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Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE(2)SPOND rationale and study design.

Abstract

BACKGROUND

Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein.

METHODS

In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures.

RESULTS

Across 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016.

CONCLUSION

This study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment.

Authors+Show Affiliations

Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA; AstraZeneca, Cambridge, UK.Joan and Sanford I Weill Department of Medicine, Weill Cornell University, New York, NY; Department of Internal Medicine, Michigan Health System, Ann Arbor, MI, USA.LungenClinic Grosshansdorf, Groβhansdorf; Department of Medicine, University Kiel, Kiel; Airway Research Center North, German Center for Lung Research, Groβhansdorf, Germany.Department of Medicine, University at Buffalo, State University of New York, Buffalo, NY, USA.Department of Medicine, Universidade Federal de Santa Catarina, Santa Catarina, Brazil.Firestone Institute of Respiratory Health, St Joseph's Healthcare, McMaster University, Hamilton, ON, Canada.AstraZeneca, Gaithersburg, MD.South Texas Veterans Health Care System at San Antonio, University of Texas Health Science Center, San Antonio, TX.Allergan plc, Jersey City, NJ, USA.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27574416

Citation

Rennard, Stephen I., et al. "Effects of Roflumilast in COPD Patients Receiving Inhaled Corticosteroid/long-acting Β2-agonist Fixed-dose Combination: RE(2)SPOND Rationale and Study Design." International Journal of Chronic Obstructive Pulmonary Disease, vol. 11, 2016, pp. 1921-8.
Rennard SI, Martinez FJ, Rabe KF, et al. Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE(2)SPOND rationale and study design. Int J Chron Obstruct Pulmon Dis. 2016;11:1921-8.
Rennard, S. I., Martinez, F. J., Rabe, K. F., Sethi, S., Pizzichini, E., McIvor, A., Siddiqui, S., Anzueto, A., & Zhu, H. (2016). Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE(2)SPOND rationale and study design. International Journal of Chronic Obstructive Pulmonary Disease, 11, 1921-8. https://doi.org/10.2147/COPD.S109661
Rennard SI, et al. Effects of Roflumilast in COPD Patients Receiving Inhaled Corticosteroid/long-acting Β2-agonist Fixed-dose Combination: RE(2)SPOND Rationale and Study Design. Int J Chron Obstruct Pulmon Dis. 2016;11:1921-8. PubMed PMID: 27574416.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE(2)SPOND rationale and study design. AU - Rennard,Stephen I, AU - Martinez,Fernando J, AU - Rabe,Klaus F, AU - Sethi,Sanjay, AU - Pizzichini,Emilio, AU - McIvor,Andrew, AU - Siddiqui,Shahid, AU - Anzueto,Antonio, AU - Zhu,Haiyuan, Y1 - 2016/08/17/ PY - 2016/8/31/entrez PY - 2016/8/31/pubmed PY - 2017/8/8/medline KW - ICS/LABA KW - RE2SPOND KW - exacerbation KW - methodology KW - phosphodiesterase-4 KW - study design SP - 1921 EP - 8 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 11 N2 - BACKGROUND: Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein. METHODS: In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures. RESULTS: Across 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016. CONCLUSION: This study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/27574416/Effects_of_roflumilast_in_COPD_patients_receiving_inhaled_corticosteroid/long_acting_β2_agonist_fixed_dose_combination:_RE_2_SPOND_rationale_and_study_design_ L2 - https://dx.doi.org/10.2147/COPD.S109661 DB - PRIME DP - Unbound Medicine ER -