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Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol.

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.

Authors+Show Affiliations

Clinical Science Center, University Hospital Aintree, Liverpool, United Kingdom. pmacal@liverpool.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22791991

Citation

Calverley, Peter M A., et al. "Does Roflumilast Decrease Exacerbations in Severe COPD Patients Not Controlled By Inhaled Combination Therapy? the REACT Study Protocol." International Journal of Chronic Obstructive Pulmonary Disease, vol. 7, 2012, pp. 375-82.
Calverley PM, Martinez FJ, Fabbri LM, et al. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82.
Calverley, P. M., Martinez, F. J., Fabbri, L. M., Goehring, U. M., & Rabe, K. F. (2012). Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. International Journal of Chronic Obstructive Pulmonary Disease, 7, 375-82. https://doi.org/10.2147/COPD.S31100
Calverley PM, et al. Does Roflumilast Decrease Exacerbations in Severe COPD Patients Not Controlled By Inhaled Combination Therapy? the REACT Study Protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82. PubMed PMID: 22791991.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. AU - Calverley,Peter M A, AU - Martinez,Fernando J, AU - Fabbri,Leonardo M, AU - Goehring,Udo-Michael, AU - Rabe,Klaus F, Y1 - 2012/06/20/ PY - 2012/7/14/entrez PY - 2012/7/14/pubmed PY - 2012/12/10/medline KW - ICS KW - LABA KW - chronic obstructive pulmonary disease KW - exacerbation KW - protocol KW - roflumilast SP - 375 EP - 82 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 7 N2 - 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. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/22791991/Does_roflumilast_decrease_exacerbations_in_severe_COPD_patients_not_controlled_by_inhaled_combination_therapy_The_REACT_study_protocol_ DB - PRIME DP - Unbound Medicine ER -