Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol.
Peter M.A. Calverley,Fernando J. Martinez,Leonardo M. Fabbri,Udo-Michael Goehring,Klaus F. Rabe +4 more
TL;DR: It is hypothesized that because roflumilast (a phosphodiesterase-4 inhibitor) has a different mode of action to bronchodilators and inhaled corticosteroids, it may provide additional benefits when added to these treatments in frequent exacerbators.
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Abstract: Background Many patients with chronic obstructive pulmonary disease (COPD) continue to suffer exacerbations, even when treated with maximum recommended therapy (eg, inhaled combinations of long-acting β2-agonist and high dose inhaled corticosteroids, with or without a long-acting anticholinergic [long-acting muscarinic antagonist]) Roflumilast is approved to treat severe COPD in patients with chronic bronchitis--and a history of frequent exacerbations--as an add-on to bronchodilators Purpose The REACT (Roflumilast in the Prevention of COPD Exacerbations While Taking Appropriate Combination Treatment) study (identification number RO-2455-404-RD, clinicaltrials gov identifier NCT01329029) will investigate whether roflumilast further reduces exacerbations when added to inhaled combination therapy in patients still suffering from frequent exacerbations Patients and methods REACT is a 1-year randomized, double-blind, multicenter, phase III/IV study of roflumilast 500 μg once daily or placebo on top of a fixed long-acting β2-agonist/inhaled corticosteroid combination A concomitant long-acting muscarinic antagonist will be allowed at stable doses The primary outcome is the rate of moderate or severe COPD exacerbations Using a Poisson regression model with a two-sided significance level of 5%, a sample size of 967 patients per treatment group is needed for 90% power COPD patients with severe to very severe airflow limitation, symptoms of chronic bronchitis, and at least two exacerbations in the previous year will be recruited Conclusion It is hypothesized that because roflumilast (a phosphodiesterase-4 inhibitor) has a different mode of action to bronchodilators and inhaled corticosteroids, it may provide additional benefits when added to these treatments in frequent exacerbators REACT will be important to determine the role of roflumilast in COPD management Here, the design and rationale for this important study is described
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Citations
Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD.
TL;DR: The frequent discontinuation of roflumilast suggests that the dose-escalation strategy may not be useful in Asian patients, and this study aimed to determine if a dose- escalation strategy is useful to improve the drug adherence rate.
The use of roflumilast in COPD: a review
Andrea Zanini,Francesca Cherubino,Patrizia Pignatti,Antonio Spanevello +3 more
- 19 Aug 2015
TL;DR: Roflumilast is an anti-inflammatory drug which has been licensed as an add-on therapy for COPD patients with forced expiratory volume in the first second <50% and frequent exacerba- tions, and its interaction with concomitant inhaled treatments is generally well tolerated.
What Affects Chronic Obstructive Pulmonary Disease in Korea
Hae-Wol Cho,Chaeshin Chu +1 more
TL;DR: A large number of patients with advanced COPD are experiencing depression or decreased quality of life, which is associated with severe dyspnea accompanied by coughing, sputum and fatigue, as well as cardiovascular complications such as cardiac insufficiency.
1
A clinical study on safety and efficacy of formoterol and tiotropium combination compared to formoterol and tiotropium with roflumilast combination in treatment of moderate to severe chronic obstructive pulmonary disease patients
Kavitha Devi M,S. Sarumathy,Sarath Lal Sasidharan,Mehanaz Shaik,Gottimukkala Sandeep,Vunnam Rajasekhar,Damodharan N +6 more
TL;DR: Tiotropium and formoterol with roflumilast combination were found to be safe and effective in moderate-to-severe COPD patients.
1
Rebuttal From Dr Rho et al
Jason Rho,Nancy Ho,Vinay Prasad +2 more
TL;DR: It appears future roflumilast trials may be better but remain far from good, because of their heavily restricted inclusion and exclusion criteria and, in certain cases, reliance on end points of dubious clinical significance, which undermine generalizability.
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