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Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 28, 2011
Last updated: March 16, 2017
Last verified: March 2017
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.

Condition Intervention Phase
COPD Exacerbation
Lung Diseases
Respiratory Disorders
Pulmonary Disease
Chronic Obstructive Lung Diseases
Chronic Obstructive Airway Disease
Drug: Roflumilast
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. [ Time Frame: Baseline to Week 52 ]
    Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

Secondary Outcome Measures:
  • Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations) [ Time Frame: Week 0 (Visit 2) to Week 52 ]
    Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

  • Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics [ Time Frame: Week 0 (Visit 2) to Week 52 ]
    Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.

  • Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Week 0 (Visit 2) to Week 52 ]
    Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)

Enrollment: 2354
Actual Study Start Date: September 30, 2011
Study Completion Date: January 31, 2016
Primary Completion Date: November 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Roflumilast
Roflumilast 500 µg, oral administration, once per day
Other Name: Daliresp
Placebo Comparator: 2
Drug: Placebo
Dose-matched placebo, oral administration, once per day.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01443845

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Sponsors and Collaborators
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01443845     History of Changes
Other Study ID Numbers: ROF-MD-07
Study First Received: September 28, 2011
Results First Received: November 30, 2016
Last Updated: March 16, 2017

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases processed this record on May 22, 2017