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

Phase 4

Completed

• Conditions: COPD; Respiratory Disorders; Pulmonary Disease; Lung Diseases; Chronic Obstructive Lung Diseases; COPD Exacerbation; Chronic Obstructive Airway Disease
• Interventions: Drug: Roflumilast; Drug: Placebo

• Registration Number: NCT01443845
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Study Start: 2011-09-30
• Study First Posted: 2011-09-30
• Primary Completion: 2015-11-30
• Study Completion: 2016-01-31
• Results First Submitted: 2016-11-30
• Results First Submitted QC: 2016-11-30
• Results First Posted: 2017-01-25
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2354

Inclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Roflumilast	Roflumilast
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.	Baseline to Week 52	Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.

Secondary Outcome Measures

Name	Time	Method
Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)	Week 0 (Visit 2) to Week 52	Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics	Week 0 (Visit 2) to Week 52	Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.
Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)	Week 0 (Visit 2) to Week 52	Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)

Trial Locations

Locations (338)

Forest Investigative Site 081; 🇺🇸 Anniston, Alabama, United States

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

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