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Alberto Papi - One of the best experts on this subject based on the ideXlab platform.

  • beclometasone formoterol as maintenance and reliever treatment in patients with asthma a double blind randomised controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Alberto Papi, Leonardo M Fabbri, Stefano Petruzzelli, Massimo Corradi, Catherine Pigeonfrancisco, Roberta Baronio, Zenon Siergiejko, Klaus F Rabe
    Abstract:

    Summary Background According to international treatment guidelines, inhaled rapid-acting β 2 agonists should be used for the control of symptoms in patients with asthma. We compared the efficacy and safety of an extrafine combination inhaler containing a corticosteroid (beclometasone) plus a rapid-onset, long-acting β 2 agonist (formoterol) with a short-acting β 2 agonist (salbutamol) as reliever strategies in patients taking beclometasone–formoterol combination as maintenance treatment. Methods In a double-blind trial undertaken in 183 centres in 14 European countries over 48 weeks, patients (aged ≥18 years) with asthma that was not fully controlled, with a forced expiratory volume in 1 s (FEV 1 ) of at least 60% predicted, had a 2-week run in. During this period, patients were treated with a combination of beclometasone 100 μg and formoterol 6 μg per one inhalation twice daily plus salbutamol 100 μg as required delivered by use of a pressurised metered-dose inhaler. They were then randomly assigned in a 1:1 ratio with a computer-generated randomisation list to receive beclometasone 100 μg plus formoterol 6 μg or salbutamol 100 μg as reliever in addition to maintenance with beclometasone 100 μg plus formoterol 6 μg twice daily. Primary outcome was the time to first severe exacerbation (admission to hospital or visit to emergency department, or use of systemic steroids for ≥3 consecutive days). Secondary outcomes were number of severe exacerbations (events per 100 patients per year), time to and number of mild exacerbations, additional exacerbation variables, lung function, symptom scores, and asthma control. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number NCT00861926. Findings 1714 patients were randomly assigned to the as-needed beclometasone–formoterol (n=857) and as-needed salbutamol groups (n=857), and 1701 were analysed (852 and 849, respectively). 326 severe exacerbations were reported by 251 patients during the study, and 99 versus 152 patients had at least one exacerbation during the 48 weeks, respectively. Compared with beclometasone–formoterol plus salbutamol as needed, beclometasone–formoterol for both maintenance and reliever treatment significantly increased the time to first exacerbation (209 days vs 134 days) by 75 days, with a 36% reduction in risk (hazard ratio 0·64 [95% CI 0·49 to 0·82]; p=0·0005), and the estimated probability was 12% and 18%, respectively (p=0·0003). The number of days with mild asthma exacerbations was also lower with as-needed beclometasone–formoterol than with as-needed salbutamol (56·04 days per patient per year vs 65·11 days per patient per year; 0·86 [0·76 to 0·98]; p=0·021). From the run-in period to week 48, both treatments improved symptoms (mean change −1·59 [–1·94 to −1·25] in the as-needed beclometasone–formoterol group vs −1·44 [–1·78 to −1·10] in the as-needed salbutamol group, difference −0·15 [–0·60 to 0·30]; p=0·507), percentage of asthma control days (9·5% [7·3 to 11·8] vs 10·9% [8·7 to 13·1], respectively, −1·4 [–4·3 to 1·6]; p=0·359), use of reliever (–0·29 [–0·38 to −0·20] vs −0·27 [–0·36 to −0·19], respectively, −0·02 [–0·13 to 0·10]; p=0·794), and lung function (FEV 1 , 0·090 [0·060 to 0·120] vs 0·090 [0·060–0·120], respectively, 0·001 [–0·040 to 0·040]; p=0·969), and were well tolerated (patients with serious adverse events, 32 [4%] and 41 [5%], respectively). Interpretation Our results lend support to the use of the combination of a single inhaled corticosteroid plus a rapid-onset, long-acting β 2 agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of beclometasone–formoterol for this use. Funding Chiesi Farmaceutici.

  • Beclomethasone formoterol in the management of copd a randomised controlled trial
    Respiratory Medicine, 2010
    Co-Authors: Pma Calverley, Piotr Kuna, Eduard Monsó, Marco Costantini, Stefano Petruzzelli, Francesco Sergio, G. Varoli, Alberto Papi, Vito Brusasco
    Abstract:

    Summary Objectives To evaluate the effect of Beclomethasone/formoterol versus budesonide/formoterol (non-inferiority) and versus formoterol (superiority) in patients with severe stable chronic obstructive pulmonary disease (COPD). Methods A double-blind, double-dummy, randomised, active-controlled, parallel-group study. After 4 weeks run-in with ipratropium/salbutamol (40/200 μg, three times daily) patients were randomised to receive Beclomethasone/formoterol (200/12 μg pressurised metered dose inhaler), budesonide/formoterol (400/12 μg dry powder inhaler) or formoterol (12 μg dry powder inhaler) twice daily for 48 weeks. Co-primary efficacy variables were change from baseline to 48 weeks in pre-dose morning forced expiratory volume in 1 s (FEV 1 ) and mean rate of COPD exacerbations. Results Of 718 patients randomised, 703 (232 Beclomethasone/formoterol, 238 budesonide/formoterol, 233 formoterol) were in the ITT analysis. Improvement in pre-dose morning FEV 1 was 0.077 L, 0.080 L and 0.026 L for Beclomethasone/formoterol, budesonide/formoterol and formoterol respectively (LS mean from the ANCOVA model). Beclomethasone/formoterol was not inferior to budesonide/formoterol (95% CI of the difference −0.052, 0.048) and superior to formoterol ( p  = 0.046). The overall rate of COPD exacerbations/patient/year was similar and not statistically significantly different among treatments (Beclomethasone/formoterol 0.414, budesonide/formoterol 0.423 and formoterol 0.431). Quality of life and COPD symptoms improved in all groups and use of rescue medication decreased. Safety profiles were as expected and treatments well-tolerated. Conclusions Beclomethasone/formoterol (400/24 μg) treatment for 48 weeks improved pulmonary function, reduced symptoms compared to formoterol, was safe and well-tolerated in patients with severe stable COPD. Neither of the long-acting β2-agonist/inhaled corticosteroid combinations affected the low exacerbation rate seen in this population.

  • Beclomethasone formoterol vs fluticasone salmeterol inhaled combination in moderate to severe asthma
    Allergy, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    Background: Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The present study was designed to compare a new fixed combination of extrafine Beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol. Methods: This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either Beclomethasone 100 lg plus formoterol 6 l go r fluticasone 125 lg plus salmeterol 25 lg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler. Results: The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference )3.32 l/min; 95% CI )17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio. Conclusions: The new combination of extrafine Beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. (ClinicalTrials.gov number, NCT00394368).

  • rescue use of Beclomethasone and albuterol in a single inhaler for mild asthma
    The New England Journal of Medicine, 2007
    Co-Authors: Alberto Papi, Dario Olivieri, Giorgio Walter Canonica, P Maestrelli, Pierluigi Paggiaro, Ernesto Pozzi, Nunzio Crimi, Antonio M Vignola, Paolo Morelli, Gabriele Nicolini
    Abstract:

    Background Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of Beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled Beclomethasone and superior to the as-needed use of inhaled albuterol. Methods We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 μg of Beclomethasone and 100 μg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 μg of albuterol as needed (as-needed albuterol therapy); 250 μg of Beclomethasone twice daily and 100 μg of albuterol as needed (regular Beclomethasone therapy); or 250 μg of Beclomethasone and 100 μg of albuterol in a single inhaler twice...

  • Beclomethasone formoterol versus budesonide formoterol combination therapy in asthma
    European Respiratory Journal, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite® (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler® (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 μg plus formoterol 12 μg b.i.d. delivered via a pMDI or budesonide 400 μg plus formoterol 12 μg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite® pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

Leonardo M Fabbri - One of the best experts on this subject based on the ideXlab platform.

  • beclometasone formoterol as maintenance and reliever treatment in patients with asthma a double blind randomised controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Alberto Papi, Leonardo M Fabbri, Stefano Petruzzelli, Massimo Corradi, Catherine Pigeonfrancisco, Roberta Baronio, Zenon Siergiejko, Klaus F Rabe
    Abstract:

    Summary Background According to international treatment guidelines, inhaled rapid-acting β 2 agonists should be used for the control of symptoms in patients with asthma. We compared the efficacy and safety of an extrafine combination inhaler containing a corticosteroid (beclometasone) plus a rapid-onset, long-acting β 2 agonist (formoterol) with a short-acting β 2 agonist (salbutamol) as reliever strategies in patients taking beclometasone–formoterol combination as maintenance treatment. Methods In a double-blind trial undertaken in 183 centres in 14 European countries over 48 weeks, patients (aged ≥18 years) with asthma that was not fully controlled, with a forced expiratory volume in 1 s (FEV 1 ) of at least 60% predicted, had a 2-week run in. During this period, patients were treated with a combination of beclometasone 100 μg and formoterol 6 μg per one inhalation twice daily plus salbutamol 100 μg as required delivered by use of a pressurised metered-dose inhaler. They were then randomly assigned in a 1:1 ratio with a computer-generated randomisation list to receive beclometasone 100 μg plus formoterol 6 μg or salbutamol 100 μg as reliever in addition to maintenance with beclometasone 100 μg plus formoterol 6 μg twice daily. Primary outcome was the time to first severe exacerbation (admission to hospital or visit to emergency department, or use of systemic steroids for ≥3 consecutive days). Secondary outcomes were number of severe exacerbations (events per 100 patients per year), time to and number of mild exacerbations, additional exacerbation variables, lung function, symptom scores, and asthma control. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number NCT00861926. Findings 1714 patients were randomly assigned to the as-needed beclometasone–formoterol (n=857) and as-needed salbutamol groups (n=857), and 1701 were analysed (852 and 849, respectively). 326 severe exacerbations were reported by 251 patients during the study, and 99 versus 152 patients had at least one exacerbation during the 48 weeks, respectively. Compared with beclometasone–formoterol plus salbutamol as needed, beclometasone–formoterol for both maintenance and reliever treatment significantly increased the time to first exacerbation (209 days vs 134 days) by 75 days, with a 36% reduction in risk (hazard ratio 0·64 [95% CI 0·49 to 0·82]; p=0·0005), and the estimated probability was 12% and 18%, respectively (p=0·0003). The number of days with mild asthma exacerbations was also lower with as-needed beclometasone–formoterol than with as-needed salbutamol (56·04 days per patient per year vs 65·11 days per patient per year; 0·86 [0·76 to 0·98]; p=0·021). From the run-in period to week 48, both treatments improved symptoms (mean change −1·59 [–1·94 to −1·25] in the as-needed beclometasone–formoterol group vs −1·44 [–1·78 to −1·10] in the as-needed salbutamol group, difference −0·15 [–0·60 to 0·30]; p=0·507), percentage of asthma control days (9·5% [7·3 to 11·8] vs 10·9% [8·7 to 13·1], respectively, −1·4 [–4·3 to 1·6]; p=0·359), use of reliever (–0·29 [–0·38 to −0·20] vs −0·27 [–0·36 to −0·19], respectively, −0·02 [–0·13 to 0·10]; p=0·794), and lung function (FEV 1 , 0·090 [0·060 to 0·120] vs 0·090 [0·060–0·120], respectively, 0·001 [–0·040 to 0·040]; p=0·969), and were well tolerated (patients with serious adverse events, 32 [4%] and 41 [5%], respectively). Interpretation Our results lend support to the use of the combination of a single inhaled corticosteroid plus a rapid-onset, long-acting β 2 agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of beclometasone–formoterol for this use. Funding Chiesi Farmaceutici.

  • Beclomethasone formoterol vs fluticasone salmeterol inhaled combination in moderate to severe asthma
    Allergy, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    Background: Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The present study was designed to compare a new fixed combination of extrafine Beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol. Methods: This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either Beclomethasone 100 lg plus formoterol 6 l go r fluticasone 125 lg plus salmeterol 25 lg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler. Results: The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference )3.32 l/min; 95% CI )17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio. Conclusions: The new combination of extrafine Beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. (ClinicalTrials.gov number, NCT00394368).

  • Beclomethasone formoterol versus budesonide formoterol combination therapy in asthma
    European Respiratory Journal, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite® (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler® (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 μg plus formoterol 12 μg b.i.d. delivered via a pMDI or budesonide 400 μg plus formoterol 12 μg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite® pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

  • Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma.
    The European respiratory journal, 2006
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

  • comparison of fluticasone propionate with Beclomethasone dipropionate in moderate to severe asthma treated for one year international study group
    Thorax, 1993
    Co-Authors: Leonardo M Fabbri, P S Burge, L Croonenborgh, F Warlies, B Weeke, A Ciaccia, C Parker
    Abstract:

    BACKGROUND--High dose inhaled glucocorticosteroids are increasingly used in the management of patients with moderate to severe asthma. Although effective, they may cause systemic side effects. Fluticasone propionate is a topically active inhaled glucocorticosteroid which has few systemic effects at high doses. METHODS--Fluticasone propionate, 1.5 mg per day, was compared with Beclomethasone dipropionate at the same dose for one year in patients with symptomatic moderate to severe asthma; 142 patients received fluticasone propionate and 132 received Beclomethasone dipropionate. The study was multicentre, double blind and of a parallel design. For the first three months patients attended the clinic every four weeks and completed daily diary cards. For the next nine months they were only seen at three monthly intervals in the clinic. RESULTS--During the first three months diary card peak expiratory flow (PEF) rate and lung function measurements in the clinic showed significantly greater improvement in patients receiving fluticasone propionate (difference in morning PEF 15 l/min (95% CI 6 to 25)), and these differences were apparent at the end of the first week. The improved lung function was maintained throughout the 12 month period and the number of severe exacerbations in patients receiving fluticasone propionate was reduced by 8% compared with those receiving Beclomethasone dipropionate. No significant differences between the two groups were observed in morning plasma cortisol levels, urinary free cortisol levels, or response to synthetic ACTH stimulation. In addition, both the rates of withdrawal and of adverse events were low, and there were fewer exacerbations of asthma with fluticasone propionate than Beclomethasone dipropionate. CONCLUSIONS--This study shows that fluticasone propionate in a daily dose of 1.5 mg results in a significantly greater increase in PEF and asthma control than the same dose of Beclomethasone dipropionate, with no increase in systemic or other side effects.

Gabriele Nicolini - One of the best experts on this subject based on the ideXlab platform.

  • Beclomethasone formoterol vs fluticasone salmeterol inhaled combination in moderate to severe asthma
    Allergy, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    Background: Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The present study was designed to compare a new fixed combination of extrafine Beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol. Methods: This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either Beclomethasone 100 lg plus formoterol 6 l go r fluticasone 125 lg plus salmeterol 25 lg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler. Results: The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference )3.32 l/min; 95% CI )17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio. Conclusions: The new combination of extrafine Beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. (ClinicalTrials.gov number, NCT00394368).

  • rescue use of Beclomethasone and albuterol in a single inhaler for mild asthma
    The New England Journal of Medicine, 2007
    Co-Authors: Alberto Papi, Dario Olivieri, Giorgio Walter Canonica, P Maestrelli, Pierluigi Paggiaro, Ernesto Pozzi, Nunzio Crimi, Antonio M Vignola, Paolo Morelli, Gabriele Nicolini
    Abstract:

    Background Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of Beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled Beclomethasone and superior to the as-needed use of inhaled albuterol. Methods We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 μg of Beclomethasone and 100 μg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 μg of albuterol as needed (as-needed albuterol therapy); 250 μg of Beclomethasone twice daily and 100 μg of albuterol as needed (regular Beclomethasone therapy); or 250 μg of Beclomethasone and 100 μg of albuterol in a single inhaler twice...

  • Beclomethasone formoterol versus budesonide formoterol combination therapy in asthma
    European Respiratory Journal, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite® (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler® (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 μg plus formoterol 12 μg b.i.d. delivered via a pMDI or budesonide 400 μg plus formoterol 12 μg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite® pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

  • Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma.
    The European respiratory journal, 2006
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

Pierluigi Paggiaro - One of the best experts on this subject based on the ideXlab platform.

  • Beclomethasone formoterol vs fluticasone salmeterol inhaled combination in moderate to severe asthma
    Allergy, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    Background: Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The present study was designed to compare a new fixed combination of extrafine Beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol. Methods: This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either Beclomethasone 100 lg plus formoterol 6 l go r fluticasone 125 lg plus salmeterol 25 lg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler. Results: The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference )3.32 l/min; 95% CI )17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio. Conclusions: The new combination of extrafine Beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. (ClinicalTrials.gov number, NCT00394368).

  • rescue use of Beclomethasone and albuterol in a single inhaler for mild asthma
    The New England Journal of Medicine, 2007
    Co-Authors: Alberto Papi, Dario Olivieri, Giorgio Walter Canonica, P Maestrelli, Pierluigi Paggiaro, Ernesto Pozzi, Nunzio Crimi, Antonio M Vignola, Paolo Morelli, Gabriele Nicolini
    Abstract:

    Background Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of Beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled Beclomethasone and superior to the as-needed use of inhaled albuterol. Methods We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 μg of Beclomethasone and 100 μg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 μg of albuterol as needed (as-needed albuterol therapy); 250 μg of Beclomethasone twice daily and 100 μg of albuterol as needed (regular Beclomethasone therapy); or 250 μg of Beclomethasone and 100 μg of albuterol in a single inhaler twice...

  • Beclomethasone formoterol versus budesonide formoterol combination therapy in asthma
    European Respiratory Journal, 2007
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite® (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler® (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 μg plus formoterol 12 μg b.i.d. delivered via a pMDI or budesonide 400 μg plus formoterol 12 μg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite® pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

  • Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma.
    The European respiratory journal, 2006
    Co-Authors: Alberto Papi, Gabriele Nicolini, Pierluigi Paggiaro, A M Vignola, Leonardo M Fabbri
    Abstract:

    The present study was designed to compare the fixed combination of Beclomethasone and formoterol in a hydrofluoroalkane Modulite (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with Beclomethasone 200 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of Beclomethasone and formoterol in hydrofluoroalkane Modulite pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

G Della Cioppa - One of the best experts on this subject based on the ideXlab platform.

  • the anti ige antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics
    European Respiratory Journal, 2001
    Co-Authors: M Soler, R. Buhl, H Fox, Jonathan Matz, R Townley, J Obrien, J Thirlwell, N Gupta, G Della Cioppa
    Abstract:

    The clinical benefit and steroid-sparing effect of treatment with the anti-immunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderate-to-severe allergic asthma. After a run-in period, 546 allergic asthmatics (aged 12-76 yrs), symptomatic despite inhaled corticosteroids (500-1,200 microg daily of Beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant Beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable. Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (p<0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (p<0.001) despite the greater reduction of the Beclomethasone dosage on omalizumab (p<0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups. These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement.

  • the anti ige antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics
    European Respiratory Journal, 2001
    Co-Authors: M Soler, R. Buhl, Jonathan Matz, R Townley, J Obrien, J Thirlwell, N Gupta, G Della Cioppa
    Abstract:

    The clinical benefit and steroid-sparing effect of treatment with the anti-immunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderate-to-severe allergic asthma. After a run-in period, 546 allergic asthmatics (aged 12–76 yrs), symptomatic despite inhaled corticosteroids (500–1,200 µg daily of Beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant Beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable. Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (p<0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (p<0.001) despite the greater reduction of the Beclomethasone dosage on omalizumab (p<0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups. These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement. This study was supported by Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA.