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 May 2014 by Forest Laboratories
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Rate of moderate or severe COPD exacerbations per subject per year [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2300
Study Start Date: September 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443845

Contacts
Contact: Sandra Beaird, PhD 1-800-678-1605 ext 66297 FRXClinTrials@frx.com

  Show 483 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Nazim Khan, MD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01443845     History of Changes
Other Study ID Numbers: ROF-MD-07
Study First Received: September 28, 2011
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Latvia: State Agency of Medicines
Malaysia: Ministry of Health
Mexico: Secretaria de Salud
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Instituto Nacional de Salud
Philippines: Bureau of Food and Drugs
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Forest Laboratories:
COPD
Exacerbations
Roflumilast
Daliresp

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on July 29, 2014