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

NCT01443845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2354

Last updated 2017-04-13

Study results available
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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.

Conditions

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

Interventions

DRUG

Roflumilast

Roflumilast 500 µg, oral administration, once per day

DRUG

Placebo

Dose-matched placebo, oral administration, once per day.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Colombia
  • Italy
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Romania
  • Russia
  • Serbia
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443845 on ClinicalTrials.gov