Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01443845 |
Recruitment Status
:
Completed
First Posted
: September 30, 2011
Results First Posted
: January 25, 2017
Last Update Posted
: April 13, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD 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 (Clinical Trial) |
Actual Enrollment : | 2354 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (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) |
Actual Study Start Date : | September 30, 2011 |
Actual Primary Completion Date : | November 30, 2015 |
Actual Study Completion Date : | January 31, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Roflumilast
|
Drug: Roflumilast
Roflumilast 500 µg, oral administration, once per day
Other Name: Daliresp
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Dose-matched placebo, oral administration, once per day.
|
- 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.
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443845

Additional Information:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01443845 History of Changes |
Other Study ID Numbers: |
ROF-MD-07 |
First Posted: | September 30, 2011 Key Record Dates |
Results First Posted: | January 25, 2017 |
Last Update Posted: | April 13, 2017 |
Last Verified: | March 2017 |
Keywords provided by AstraZeneca:
COPD Exacerbations Roflumilast Daliresp |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases |