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 November 2014 by Forest Laboratories
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: November 26, 2014
Last verified: November 2014
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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: | February 2016 |
| Estimated Primary Completion Date: | November 2015 (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
Show 489 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443845
Contacts
| Contact: Reynold Daniel | (201) 427-8000 ext 2038 | reynold.daniel@frx.com |
Show 489 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Michelle Patel, BA | Forest Research Institute, a subsidiary of Actavis plc. |
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: | November 26, 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 Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on March 03, 2015