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Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

NCT00163475 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2016-10-25

No results posted yet for this study

Summary

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Conditions

Interventions

DRUG

Roflumilast

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca AstraZeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • Australia
  • Belgium
  • France
  • South Africa
  • Spain

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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 NCT00163475 on ClinicalTrials.gov