Trial record 7 of 3707 for:
"Lung Diseases, Obstructive"
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.
Verified August 2012 by Forest Laboratories
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: August 1, 2012
Last verified: August 2012
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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: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443845
Show 392 Study Locations
Contacts
| Contact: Sandra Beaird, PhD | 1-800-678-1605 ext 66297 | info@forestpharm.com |
Show 392 Study LocationsSponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Paul Rowe, 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: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Latvia: State Agency of Medicines Romania: National Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Mexico: Secretaria de Salud Peru: Instituto Nacional de Salud Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Taiwan : Food and Drug Administration Malaysia: Ministry of Health Thailand: Food and Drug Administration Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices 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 May 16, 2013