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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.

  • Beclometasone\u2013formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial
    'Elsevier BV', 2013
    Co-Authors: Alberto Papi, Stefano Petruzzelli, Massimo Corradi, Roberta Baronio, Zenon Siergiejko, Catherine Pigeon Francisco, Fabbri Leonardo, Klaus F Rabe
    Abstract:

    Summary Background According to international treatment guidelines, inhaled rapid-acting \u3b22 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 \u3b22 agonist (formoterol) with a short-acting \u3b22 agonist (salbutamol) as reliever strategies in patients taking Beclometasone\u2013formoterol combination as maintenance treatment. Methods In a double-blind trial undertaken in 183 centres in 14 European countries over 48 weeks, patients (aged 6518 years) with asthma that was not fully controlled, with a forced expiratory volume in 1 s (FEV1) of at least 60% predicted, had a 2-week run in. During this period, patients were treated with a combination of Beclometasone 100 \u3bcg and formoterol 6 \u3bcg per one inhalation twice daily plus salbutamol 100 \u3bcg 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 \u3bcg plus formoterol 6 \u3bcg or salbutamol 100 \u3bcg as reliever in addition to maintenance with Beclometasone 100 \u3bcg plus formoterol 6 \u3bcg 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 653 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\u2013formoterol (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\u2013formoterol plus salbutamol as needed, Beclometasone\u2013formoterol 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\ub764 [95% CI 0\ub749 to 0\ub782]; p=0\ub70005), and the estimated probability was 12% and 18%, respectively (p=0\ub70003). The number of days with mild asthma exacerbations was also lower with as-needed Beclometasone\u2013formoterol than with as-needed salbutamol (56\ub704 days per patient per year vs 65\ub711 days per patient per year; 0\ub786 [0\ub776 to 0\ub798]; p=0\ub7021). From the run-in period to week 48, both treatments improved symptoms (mean change 121\ub759 [\u20131\ub794 to 121\ub725] in the as-needed Beclometasone\u2013formoterol group vs 121\ub744 [\u20131\ub778 to 121\ub710] in the as-needed salbutamol group, difference 120\ub715 [\u20130\ub760 to 0\ub730]; p=0\ub7507), percentage of asthma control days (9\ub75% [7\ub73 to 11\ub78] vs 10\ub79% [8\ub77 to 13\ub71], respectively, 121\ub74 [\u20134\ub73 to 1\ub76]; p=0\ub7359), use of reliever (\u20130\ub729 [\u20130\ub738 to 120\ub720] vs 120\ub727 [\u20130\ub736 to 120\ub719], respectively, 120\ub702 [\u20130\ub713 to 0\ub710]; p=0\ub7794), and lung function (FEV1, 0\ub7090 [0\ub7060 to 0\ub7120] vs 0\ub7090 [0\ub7060\u20130\ub7120], respectively, 0\ub7001 [\u20130\ub7040 to 0\ub7040]; p=0\ub7969), 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 \u3b22 agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of Beclometasone\u2013formoterol for this use

  • 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...

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.

  • 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.

Brian J Lipworth - One of the best experts on this subject based on the ideXlab platform.

  • effects of adding either a leukotriene receptor antagonist or low dose theophylline to a low or medium dose of inhaled corticosteroid in patients with persistent asthma
    Chest, 2002
    Co-Authors: Owen J Dempsey, Andrew M Wilson, Stephen J Fowler, Gwen Kennedy, Brian J Lipworth
    Abstract:

    Study objectives: To evaluate the effect of adding zafirlukast or low-dose theophylline to a beclomethasone dipropionate (BDP) extra-fine hydrofluoroalkane aerosol on bronchial hyperresponsiveness as the primary outcome variable. Methods: Twenty-four patients with mild-to-moderate asthma were studied using a randomized crossover design with the following three treatment blocks: (1) beclomethasone, 100 g/d, alone for the first 2 weeks followed by 400 g/d alone for the next 2 weeks; (2) beclomethasone, 100 g/d, followed by 400 g/d, with the addition of zafirlukast, 20 mg bid; (3) beclomethasone, 100 g/d, followed by 400 g/d, with the addition of theophylline, 200 to 300 mg bid. Measurements were made after 2 and 4 weeks of each treatment and at pretreatment baseline. Results: The mean trough plasma theophylline concentration was 6.7 mg/L, coinciding with the anti-inflammatory target range (ie, 5 to 10 mg/L). The provocative dose of methacholine causing a 20% fall in FEV1 (as doubling dose difference from baseline) was significantly (p < 0.05) greater with beclomethasone, 100 g, plus zafirlukast (1.1 doubling dose) but not with beclomethasone, 100 g, plus theophylline (0.7 doubling dose) compared to beclomethasone, 100 g alone (0.4 doubling dose), but not compared to beclomethasone, 400 g alone (1.1 doubling dose). There were also significant (p < 0.05) differences between beclomethasone, 100 g, plus zafirlukast (but not BDP, 100 g, plus theophylline) vs beclomethasone, 100 g, alone in terms of nitric oxide level, midexpiratory phase of forced expiratory flow, and peak expiratory flow. There were no further significant improvements observed with the addition of zafirlukast or theophylline to beclomethasone, 400 g. Conclusions: A leukotriene receptor antagonist, but not low-dose theophylline, conferred significant additive anti-inflammatory effects to therapy with a low-dose inhaled corticosteroid but not to that with a medium dose of an inhaled corticosteroid. Thus, optimizing the dose of inhaled corticosteroid as monotherapy would seem to be the logical first step, which is in keeping with current guidelines. (CHEST 2002; 122:151–159)

Mark Spears - One of the best experts on this subject based on the ideXlab platform.

  • effect of low dose theophylline plus Beclometasone on lung function in smokers with asthma a pilot study
    European Respiratory Journal, 2009
    Co-Authors: Mark Spears, Iona Donnelly, Lisa Jolly, M Brannigan, K Ito, C Mcsharry, Jane Lafferty, Rekha Chaudhuri, G Braganza, Ian M Adcock
    Abstract:

    Smoking is common in asthma and is associated with worse asthma control and a reduced therapeutic response to corticosteroids. The present authors hypothesised that treating smokers with asthma with low-dose theophylline added to inhaled corticosteroids would enhance steroid sensitivity and thereby improve lung function and symptoms. In a double-blind, parallel group exploratory trial, 68 asthmatic smokers were randomised to one of three treatments for 4 weeks: inhaled Beclometasone (200 mg?day -1 ), theophylline (400 mg?day -1 ) or both treatments combined. Outcome measures included change in lung function and Asthma Control Questionnaire (ACQ) scores. At 4 weeks, theophylline added to inhaled Beclometasone produced an improvement in peak expiratory flow (39.9 L?min -1 , 95% confidence intervals (CI) 10.9-68.8) and ACQ score (-0.47, 95% CI -0.91- -0.04) and a borderline improvement in pre-bronchodilator forced expiratory volume in one second (mean difference 165 mL, 95% CI -13-342) relative to inhaled corticosteroid alone. Theophylline alone improved the ACQ score (-0.55, 95% CI -0.99- -0.11), but not lung function. In the present pilot study, the combination of low-dose theophylline and inhaled Beclometasone produced improvements in both lung function and symptoms in a group of smokers with asthma. Larger trials are required to extend and confirm these findings.

  • Bronchodilatory Effect of the PPAR-γ Agonist Rosiglitazone in Smokers With Asthma
    Clinical Pharmacology & Therapeutics, 2009
    Co-Authors: Mark Spears, Iona Donnelly, Lisa Jolly, M Brannigan, K Ito, C Mcsharry, Jane Lafferty, Rekha Chaudhuri, G Braganza, P Bareille
    Abstract:

    Smokers with asthma show a reduced response to inhaled corticosteroids. We hypothesized that a peroxisome proliferator–activated receptor-γ (PPAR-γ) agonist would be superior for the clinical treatment of these asthma patients. Forty-six smokers with asthma were randomized to inhaled Beclometasone dipropionate (200 µg per day) or rosiglitazone (8 mg per day) for 4 weeks. Rosiglitazone produced improvements in lung function (forced expiratory volume in 1 s (FEV1) = 183 ml, P = 0.051; forced expiratory flow between 25 and 75% of the forced vital capacity (FEF25–75) = 0.24 l/s, P = 0.030) as compared with inhaled Beclometasone dipropionate. Further trials using PPAR-γ agonists in steroid-resistant airway disease are indicated. Clinical Pharmacology & Therapeutics (2009); 86, 1, 49–53 doi:10.1038/clpt.2009.41

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.