Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

Completed · Phase 4 · Has a placebo group

Conditions studied: COPD, COPD Exacerbation, Lung Diseases, Respiratory Disorders, Pulmonary Disease, Chronic Obstructive Lung Diseases, Chronic Obstructive Airway Disease

In brief

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.

Key facts

Study ID

NCT01443845

Run by

AstraZeneca

People needed

2354

Starts

2011-09-30

Expected to finish

2016-01-31

Last updated by the study team

2017-04-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 065 — Athens, Alabama, United States
• Forest Investigative Site 131 — Florence, Alabama, United States
• Forest Investigative Site 073 — Mobile, Alabama, United States
• Forest Investigative Site 272 — Mesa, Arizona, United States
• Forest Investigative Site 091 — Peoria, Arizona, United States
• Forest Investigative Site 034 — Phoenix, Arizona, United States
• Forest Investigative Site 188 — Phoenix, Arizona, United States
• Forest Investigative Site 211 — Phoenix, Arizona, United States
• Forest Investigative Site 247 — Phoenix, Arizona, United States
• Forest Investigative Site 208 — Fort Smith, Arkansas, United States
• Forest Investigative Site 101 — Little Rock, Arkansas, United States
• Forest Investigative Site 074 — Bellflower, California, United States
• Forest Investigative Site 060 — Fresno, California, United States
• Forest Investigative Site 329 — Fresno, California, United States
• Forest Investigative Site 245 — Fullerton, California, United States
• Forest Investigative Site 310 — Garden Grove, California, United States
• Forest Investigative Site 297 — Lakewood, California, United States
• Forest Investigative Site 116 — Long Beach, California, United States
• Forest Investigative Site 085 — Los Angeles, California, United States
• Forest Investigative Site 241 — Los Angeles, California, United States
• Forest Investigative Site 299 — Northridge, California, United States
• Forest Investigative Site 213 — Palo Alto, California, United States
• Forest Investigative Site 268 — Pismo Beach, California, United States
• Forest Investigative Site 025 — Riverside, California, United States
• Forest Investigative Site 081 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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