Phase 4
Completed N=2,354
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Chronic Obstructive Pulmonary Disease · acute exacerbation of chronic obstructive pulmonary disease · Lung Diseases · Respiratory Disease
Source: ClinicalTrials.gov NCT01443845 ↗
Enrolled (actual)
2,354
Serious AEs
14.5%
Results posted
Jan 2017
Primary outcomePrimary: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. — 1.27; 1.17 COPD exacerbations per patient per year — p=0.1634
◆ Published Evidence
Highly cited
125citations · ~13 / year
Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting β2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial.
Summary
To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
Linked Publications (3)
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Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting β2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial.
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Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials.
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The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. |
1.27; 1.17 | 0.1634 |
| SECONDARY Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations) |
0.29; 0.28 | 0.6354 |
| SECONDARY Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics |
1.45; 1.31 | 0.0884 |
| SECONDARY Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1) |
-0.0091; 0.0441 | < 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 1. Male or female patients at least 40 years of age
- 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
- 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
- 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
- 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
- 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
- 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years
Exclusion Criteria
- 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
- 2. Known alpha-1-antitrypsin deficiency
- 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
- 4. Body mass index (BMI) ≥ 45 kg/m2
- 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
Data sourced from ClinicalTrials.gov (NCT01443845) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.