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 is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Forest Laboratories
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: July 31, 2014
Last verified: July 2014

September 28, 2011
July 31, 2014
September 2011
January 2016   (final data collection date for primary outcome measure)
Rate of moderate or severe COPD exacerbations per subject per year [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01443845 on ClinicalTrials.gov Archive Site
Prebronchodilator Forced Expiratory Volume in 1 second (FEV1) in Liters [ Time Frame: Change from randomization, Week 0 (Visit 2) to Week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group 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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • COPD
  • COPD Exacerbation
  • Lung Diseases
  • Respiratory Disorders
  • Pulmonary Disease
  • Chronic Obstructive Lung Diseases
  • Chronic Obstructive Airway Disease
  • Drug: Roflumilast
    Roflumilast 500 µg, oral administration, once per day
    Other Name: Daliresp
  • Drug: Placebo
    Dose-matched placebo, oral administration, once per day.
  • Experimental: 1
    Roflumilast
    Intervention: Drug: Roflumilast
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2300
March 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1. Male or female patients at least 40 years of age
  • 2. History of COPD (according to 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
Both
40 Years and older
No
Contact: Sandra Beaird, PhD 1-800-678-1605 ext 66297 FRXClinTrials@frx.com
United States,   Argentina,   Canada,   Chile,   Colombia,   Italy,   Latvia,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   Serbia,   Spain,   Taiwan,   Thailand,   Ukraine
 
NCT01443845
ROF-MD-07
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Nazim Khan, MD Forest Research Institute, a subsidiary of Actavis plc.
Forest Laboratories
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP