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

Conditions

• COPD
• COPD Exacerbation
• Chronic Obstructive Airway Disease
• Chronic Obstructive Lung Diseases
• Lung Diseases
• Pulmonary Disease
• Respiratory Disorders

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast — DRUG
  Roflumilast 500 µg, oral administration, once per day
• Placebo — DRUG
  Dose-matched placebo, oral administration, once per day.

Study Details

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 Dates

Start date

Sep 30, 2011

Status verified

Mar 2017

Primary completion

Nov 30, 2015

Completion

Jan 31, 2016

Study Design

Enrollment

2,354 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
  Roflumilast
• Placebo Comparator: 2
  Placebo

Primary Outcome Measure

Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. [ Time Frame: Baseline to Week 52 ]

Locations (217)

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