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T Ekström - One of the best experts on this subject based on the ideXlab platform.
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Improved asthma control with Budesonide/formoterol in a single inhaler, compared with Budesonide alone.
The European respiratory journal, 2001Co-Authors: Olle Zetterström, R. Buhl, H. Mellem, M Perpina, J Hedman, S O'neill, T EkströmAbstract:Budesonide/formoterol in a single inhaler was compared with Budesonide alone, and with concurrent administration of Budesonide and formoterol from separate inhalers, in patients with asthma, not controlled with inhaled glucocorticosteroids alone. In this 12-week, double-blind, randomized, double-dummy study, 362 adult asthmatics (forced expiratory volume in one second 73.8% of predicted, inhaled glucocorticosteroid dose 960 microg x day(-1)) received single inhaler Budesonide/formoterol (Symbicort Turbuhaler) 160/4.5 microg, two inhalations b.i.d., or corresponding treatment with Budesonide, or Budesonide plus formoterol via separate inhalers. There was a greater increase in morning peak expiratory flow (PEF) with single-inhaler (35.7 L x min(-1)) and separate-inhaler (32.0 L x min(-1)) Budesonide and formoterol, compared with Budesonide alone (0.2 L x min(-1); p
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improved asthma control with Budesonide formoterol in a single inhaler compared with Budesonide alone
European Respiratory Journal, 2001Co-Authors: Olle Zetterström, R. Buhl, H. Mellem, M Perpina, J Hedman, S Oneill, T EkströmAbstract:Budesonide/formoterol in a single inhaler was compared with Budesonide alone, and with concurrent administration of Budesonide and formoterol from separate inhalers, in patients with asthma, not controlled with inhaled glucocorticosteroids alone. In this 12-week, double-blind, randomized, double-dummy study, 362 adult asthmatics (forced expiratory volume in one second 73.8% of predicted, inhaled glucocorticosteroid dose 960 microg x day(-1)) received single inhaler Budesonide/formoterol (Symbicort Turbuhaler) 160/4.5 microg, two inhalations b.i.d., or corresponding treatment with Budesonide, or Budesonide plus formoterol via separate inhalers. There was a greater increase in morning peak expiratory flow (PEF) with single-inhaler (35.7 L x min(-1)) and separate-inhaler (32.0 L x min(-1)) Budesonide and formoterol, compared with Budesonide alone (0.2 L x min(-1); p<0.001, both comparisons); the effect was apparent after 1 day (p<0.001 versus Budesonide, both comparisons). Similarly, evening PEF, use of rescue medication, total asthma symptom scores and percentage of symptom-free days improved more with both single inhaler and separate inhaler therapy than with Budesonide alone, as did asthma control days (approximately 15% more, p<0.001 versus Budesonide, both comparisons, with a marked increase in the first week). All treatments were well tolerated and the adverse event profile was similar in all three treatment groups. It is concluded that single inhaler therapy with Budesonide and formoterol is a clinically effective and well-tolerated treatment for patients with asthma that is not fully controlled by inhaled glucocorticosteroids alone.
M Pons - One of the best experts on this subject based on the ideXlab platform.
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randomised controlled trial of montelukast plus inhaled Budesonide versus double dose inhaled Budesonide in adult patients with asthma
Thorax, 2003Co-Authors: D Price, D Hernandez, P Magyar, J Fiterman, K M Beeh, I G James, S Konstantopoulos, R Rojas, J A Van Noord, M PonsAbstract:Background: Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to Budesonide with doubling the Budesonide dose in adults with asthma. Methods: After a 1 month single blind run in period, patients inadequately controlled on inhaled Budesonide (800 µg/day) were randomised to receive montelukast 10 mg + inhaled Budesonide 800 µg/day (n=448) or Budesonide 1600 µg/day (n=441) for 12 weeks. Results: Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + Budesonide group and in the double dose Budesonide group (33.5 v 30.1 l/min). During days 1–3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + Budesonide group than in the double dose Budesonide group (20.1 v 9.6 l/min, p<0.001), indicating faster onset of action in the montelukast group. Both groups showed similar improvements with respect to "as needed" s agonist use, mean daytime symptom score, nocturnal awakenings, exacerbations, asthma free days, peripheral eosinophil counts, and asthma specific quality of life. Both montelukast + Budesonide and double dose Budesonide were generally well tolerated. Conclusion: The addition of montelukast to inhaled Budesonide is an effective and well tolerated alternative to doubling the dose of inhaled Budesonide in adult asthma patients experiencing symptoms and inadequate control on Budesonide alone.
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Randomised controlled trial of montelukast plus inhaled Budesonide versus double dose inhaled Budesonide in adult patients with asthma
Thorax, 2003Co-Authors: D Price, D Hernandez, P Magyar, J Fiterman, K M Beeh, I G James, S Konstantopoulos, R Rojas, J A Van Noord, M PonsAbstract:Background: Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to Budesonide with doubling the Budesonide dose in adults with asthma. Methods: After a 1 month single blind run in period, patients inadequately controlled on inhaled Budesonide (800 µg/day) were randomised to receive montelukast 10 mg + inhaled Budesonide 800 µg/day (n=448) or Budesonide 1600 µg/day (n=441) for 12 weeks. Results: Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + Budesonide group and in the double dose Budesonide group (33.5 v 30.1 l/min). During days 1–3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + Budesonide group than in the double dose Budesonide group (20.1 v 9.6 l/min, p
Paul M Obyrne - One of the best experts on this subject based on the ideXlab platform.
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effect of a single day of increased as needed Budesonide formoterol use on short term risk of severe exacerbations in patients with mild asthma a post hoc analysis of the sygma 1 study
The Lancet Respiratory Medicine, 2020Co-Authors: Paul M Obyrne, Peter J Barnes, Rosa Lamarca, Margareta Puu, Mark J Fitzgerald, Eric D Bateman, Jinping Zheng, Per Gustafson, Christina Keen, Vijay AlagappanAbstract:Summary Background In mild asthma, as-needed Budesonide–formoterol reduces long-term exacerbation risk compared with as-needed short-acting β2-agonist (SABA), with a similar or increased reduction versus maintenance with Budesonide plus as-needed SABA, despite a lower Budesonide dose. In this post-hoc analysis of the SYmbicort Given as needed in Mild Asthma (SYGMA) 1 study, we investigated the short-term risk of severe exacerbations after a single day with various levels of reliever use. Methods SYGMA 1 was a 52-week, double-blind, randomised, controlled, phase 3 trial, in which patients aged 12 years or older with mild asthma were randomly assigned (1:1:1) to placebo twice daily plus as-needed terbutaline 0·5 mg, placebo twice daily plus as-needed Budesonide–formoterol 200–6 μg, or Budesonide 200 μg twice daily plus as-needed terbutaline (ie, Budesonide maintenance group). In this post-hoc analysis, we assessed the frequency of reliever use and the risk of a severe exacerbation in the 21 days after first use of more than two, four, six, or eight reliever inhalations in 24 h. SYGMA 1 is registered with ClinicalTrials.gov , NCT02149199 , and is now complete. Findings Of 5721 patients enrolled in SYGMA 1, 3849 were randomly assigned to as-needed terbutaline (n=1280), as-needed Budesonide–formoterol (n=1279), or Budesonide maintenance (n=1290), of whom 3836 had evaluable data (n=1277 as-needed terbutaline, n=1277 as needed Budesonide–formoterol, and n=1282 Budesonide maintenance). Median reliever use was 0·32 (IQR 0·08–0·91) inhalations per day for the as-needed terbutaline group, 0·29 (0·07–0·72) for the as-needed Budesonide–formoterol group, and 0·16 (0·04–0·52) for the Budesonide maintenance group. Compared with as-needed terbutaline, after adjustment for age, sex, randomly assigned treatment, pre-study treatment group, baseline % predicted post-bronchodilator FEV1, and severe exacerbation in the 12 months before enrolment in the study, the hazard ratio (HR) for severe exacerbation in the 21 days after a single day with more than two as-needed inhalations was 0·27 (95% CI 0·12–0·58; p=0·0008) with as-needed Budesonide–formoterol and 0·39 (0·19–0·79; p=0·0091) with Budesonide maintenance; after a single day of more than four as-needed inhalations the HR was 0·24 (0·10–0·62; p=0·0030) with as-needed Budesonide–formoterol and 0·30 (0·13–0·72; p=0·0065) with Budesonide maintenance; and after a single day of more than six as-needed inhalations the HR was 0·14 (0·02–1·06; p=0·057) with as-needed Budesonide–formoterol and 0·43 (0·14–1·26; p=0·12) with Budesonide maintenance. HRs were not calculated for more than eight as-needed inhalations due to the small number of events. Interpretation In mild asthma, as-needed Budesonide–formoterol reduces the short-term risk of severe exacerbations after a single day of higher use (more than two as-needed inhalations), even when overall use is infrequent. Use of an anti-inflammatory reliever might reduce the risk of short-term severe exacerbations by the timely provision of increased doses of as-needed inhaled corticosteroids and formoterol when symptoms occur. These findings should be further assessed in prospective randomised clinical trials. Funding AstraZeneca.
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the sygma programme of phase 3 trials to evaluate the efficacy and safety of Budesonide formoterol given as needed in mild asthma study protocols for two randomised controlled trials
Trials, 2017Co-Authors: Paul M Obyrne, Carin Jorup, Peter J Barnes, Mark J Fitzgerald, Eric D Bateman, Christina Keen, Nanshan Zhong, Gun Almqvist, Kristine Pemberton, Stefan IvanovAbstract:In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of Budesonide/formoterol ‘as needed’ in response to symptoms may represent an alternative treatment option for patients with mild asthma. The SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week, double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with a clinical diagnosis of asthma for at least 6 months, who would qualify for treatment with regular inhaled corticosteroids (ICS). SYGMA1 aims to recruit 3750 patients who will be randomised to placebo twice daily (bid) plus as-needed Budesonide/formoterol 160/4.5 μg, placebo bid plus as-needed terbutaline 0.4 mg, or Budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the superiority of as-needed Budesonide/formoterol over as-needed terbutaline for asthma control, as measured by well-controlled asthma weeks; a secondary objective is to establish the noninferiority of as-needed Budesonide/formoterol versus maintenance Budesonide plus as-needed terbutaline using the same outcome measure. SYGMA2 aims to recruit 4114 patients who will be randomised to placebo bid plus as-needed Budesonide/formoterol 160/4.5 μg, or Budesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the noninferiority of as-needed Budesonide/formoterol over Budesonide bid plus as-needed terbutaline as measured by the annualised severe exacerbation rate. In both studies, use of all blinded study inhalers will be recorded electronically using Turbuhaler® Usage Monitors. Given the known risks of mild asthma, and known poor adherence with regular inhaled corticosteroids, the results of the SYGMA programme will help to determine the efficacy and safety of as-needed Budesonide/formoterol therapy in mild asthma. Patient recruitment is complete, and completion of the phase 3 studies is planned in 2017. ClinicalTrials.gov identifiers: NCT02149199 SYGMA1 and NCT02224157 SYGMA2. Registered on 16 May 2014 and 19 August 2014, respectively.
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low dose inhaled Budesonide and formoterol in mild persistent asthma the optima randomized trial
American Journal of Respiratory and Critical Care Medicine, 2001Co-Authors: Paul M Obyrne, Peter J Barnes, Roberto Rodriguezroisin, Eva Runnerstrom, Thomas Sandstrom, Klas Svensson, A E TattersfieldAbstract:The optimal treatment for mild asthma is uncertain. We assessed the effects of adding a long-acting inhaled beta-agonist, formoterol, to low doses of an inhaled corticosteroid, Budesonide, for 1 yr in subjects with mild asthma, receiving no or only a small dose of inhaled corticosteroid. The 698 corticosteroid free patients (Group A) were assigned to twice daily treatment with 100 microg Budesonide, 100 microg Budesonide plus 4.5 microg formoterol, or placebo. The 1,272 corticosteroid-treated patients (Group B) were assigned to twice daily treatment with 100 microg Budesonide, 100 microg Budesonide plus 4.5 microg formoterol, 200 microg Budesonide, or 200 microg Budesonide plus 4.5 microg formoterol. The main outcome variables were time to the first severe asthma exacerbation and poorly controlled asthma days. In Group A, Budesonide alone reduced the risk for severe exacerbations by 60% and poorly controlled days by 48%; adding formoterol increased lung function with no change in other end points. By contrast, in Group B, adding formoterol reduced the risk for the first severe exacerbation and for poorly controlled days by 43 and 30%, respectively. Thus, in corticosteroid-free patients, low dose inhaled Budesonide alone reduced severe exacerbations and improved asthma control, and in patients already receiving inhaled corticosteroid, adding formoterol was more effective than doubling the corticosteroid dose.
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effect of inhaled formoterol and Budesonide on exacerbations of asthma formoterol and corticosteroids establishing therapy facet international study group
The New England Journal of Medicine, 1997Co-Authors: Romain Pauwels, Claesgoran Lofdahl, Dirkje S Postma, A E Tattersfield, Paul M Obyrne, Peter J Barnes, A UllmanAbstract:BACKGROUND: The role of long-acting, inhaled beta2-agonists in treating asthma is uncertain. In a double-blind study, we evaluated the effects of adding inhaled formoterol to both lower and higher doses of the inhaled glucocorticoid Budesonide. METHODS: After a four-week run-in period of treatment with Budesonide (800 microg twice daily), 852 patients being treated with glucocorticoids were randomly assigned to one of four treatments given twice daily by means of a dry-powder inhaler (Turbuhaler): 100 microg of Budesonide plus placebo, 100 microg of Budesonide plus 12 microg of formoterol, 400 microg of Budesonide plus placebo, or 400 microg of Budesonide plus 12 microg of formoterol. Terbutaline was permitted as needed. Treatment continued for one year; we compared the frequency of exacerbations of asthma, symptoms, and lung function in the four groups. A severe exacerbation was defined by the need for oral glucocorticoids or a decrease in the peak flow to more than 30 percent below the base-line value on two consecutive days. RESULTS: The rates of severe and mild exacerbations were reduced by 26 percent and 40 percent, respectively, when formoterol was added to the lower dose of Budesonide. The higher dose of Budesonide alone reduced the rates of severe and mild exacerbations by 49 percent and 37 percent, respectively. Patients treated with formoterol and the higher dose of Budesonide had the greatest reductions -- 63 percent and 62 percent, respectively. Symptoms of asthma and lung function improved with both formoterol and the higher dose of Budesonide, but the improvements with formoterol were greater. CONCLUSIONS: In patients who have persistent symptoms of asthma despite treatment with inhaled glucocorticoids, the addition of formoterol to Budesonide therapy or the use of a higher dose of Budesonide may be beneficial. The addition of formoterol to Budesonide therapy improves symptoms and lung function without lessening the control of asthma.
Olle Zetterström - One of the best experts on this subject based on the ideXlab platform.
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Improved asthma control with Budesonide/formoterol in a single inhaler, compared with Budesonide alone.
The European respiratory journal, 2001Co-Authors: Olle Zetterström, R. Buhl, H. Mellem, M Perpina, J Hedman, S O'neill, T EkströmAbstract:Budesonide/formoterol in a single inhaler was compared with Budesonide alone, and with concurrent administration of Budesonide and formoterol from separate inhalers, in patients with asthma, not controlled with inhaled glucocorticosteroids alone. In this 12-week, double-blind, randomized, double-dummy study, 362 adult asthmatics (forced expiratory volume in one second 73.8% of predicted, inhaled glucocorticosteroid dose 960 microg x day(-1)) received single inhaler Budesonide/formoterol (Symbicort Turbuhaler) 160/4.5 microg, two inhalations b.i.d., or corresponding treatment with Budesonide, or Budesonide plus formoterol via separate inhalers. There was a greater increase in morning peak expiratory flow (PEF) with single-inhaler (35.7 L x min(-1)) and separate-inhaler (32.0 L x min(-1)) Budesonide and formoterol, compared with Budesonide alone (0.2 L x min(-1); p
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improved asthma control with Budesonide formoterol in a single inhaler compared with Budesonide alone
European Respiratory Journal, 2001Co-Authors: Olle Zetterström, R. Buhl, H. Mellem, M Perpina, J Hedman, S Oneill, T EkströmAbstract:Budesonide/formoterol in a single inhaler was compared with Budesonide alone, and with concurrent administration of Budesonide and formoterol from separate inhalers, in patients with asthma, not controlled with inhaled glucocorticosteroids alone. In this 12-week, double-blind, randomized, double-dummy study, 362 adult asthmatics (forced expiratory volume in one second 73.8% of predicted, inhaled glucocorticosteroid dose 960 microg x day(-1)) received single inhaler Budesonide/formoterol (Symbicort Turbuhaler) 160/4.5 microg, two inhalations b.i.d., or corresponding treatment with Budesonide, or Budesonide plus formoterol via separate inhalers. There was a greater increase in morning peak expiratory flow (PEF) with single-inhaler (35.7 L x min(-1)) and separate-inhaler (32.0 L x min(-1)) Budesonide and formoterol, compared with Budesonide alone (0.2 L x min(-1); p<0.001, both comparisons); the effect was apparent after 1 day (p<0.001 versus Budesonide, both comparisons). Similarly, evening PEF, use of rescue medication, total asthma symptom scores and percentage of symptom-free days improved more with both single inhaler and separate inhaler therapy than with Budesonide alone, as did asthma control days (approximately 15% more, p<0.001 versus Budesonide, both comparisons, with a marked increase in the first week). All treatments were well tolerated and the adverse event profile was similar in all three treatment groups. It is concluded that single inhaler therapy with Budesonide and formoterol is a clinically effective and well-tolerated treatment for patients with asthma that is not fully controlled by inhaled glucocorticosteroids alone.
D Price - One of the best experts on this subject based on the ideXlab platform.
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randomised controlled trial of montelukast plus inhaled Budesonide versus double dose inhaled Budesonide in adult patients with asthma
Thorax, 2003Co-Authors: D Price, D Hernandez, P Magyar, J Fiterman, K M Beeh, I G James, S Konstantopoulos, R Rojas, J A Van Noord, M PonsAbstract:Background: Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to Budesonide with doubling the Budesonide dose in adults with asthma. Methods: After a 1 month single blind run in period, patients inadequately controlled on inhaled Budesonide (800 µg/day) were randomised to receive montelukast 10 mg + inhaled Budesonide 800 µg/day (n=448) or Budesonide 1600 µg/day (n=441) for 12 weeks. Results: Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + Budesonide group and in the double dose Budesonide group (33.5 v 30.1 l/min). During days 1–3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + Budesonide group than in the double dose Budesonide group (20.1 v 9.6 l/min, p<0.001), indicating faster onset of action in the montelukast group. Both groups showed similar improvements with respect to "as needed" s agonist use, mean daytime symptom score, nocturnal awakenings, exacerbations, asthma free days, peripheral eosinophil counts, and asthma specific quality of life. Both montelukast + Budesonide and double dose Budesonide were generally well tolerated. Conclusion: The addition of montelukast to inhaled Budesonide is an effective and well tolerated alternative to doubling the dose of inhaled Budesonide in adult asthma patients experiencing symptoms and inadequate control on Budesonide alone.
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Randomised controlled trial of montelukast plus inhaled Budesonide versus double dose inhaled Budesonide in adult patients with asthma
Thorax, 2003Co-Authors: D Price, D Hernandez, P Magyar, J Fiterman, K M Beeh, I G James, S Konstantopoulos, R Rojas, J A Van Noord, M PonsAbstract:Background: Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to Budesonide with doubling the Budesonide dose in adults with asthma. Methods: After a 1 month single blind run in period, patients inadequately controlled on inhaled Budesonide (800 µg/day) were randomised to receive montelukast 10 mg + inhaled Budesonide 800 µg/day (n=448) or Budesonide 1600 µg/day (n=441) for 12 weeks. Results: Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + Budesonide group and in the double dose Budesonide group (33.5 v 30.1 l/min). During days 1–3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + Budesonide group than in the double dose Budesonide group (20.1 v 9.6 l/min, p
