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Clinical Trials/NCT00073177
NCT00073177CompletedPhase 3

A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma

AstraZeneca41 sites in 5 countries819 target enrollmentStarted: November 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
819
Locations
41
Primary Endpoint
change in lung function from baseline to final visit.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Main Inclusion Criteria:
  • •Persistent bronchial asthma
  • •No change in asthma treatment within 4 weeks prior to visit 1
  • •Non-smoker or ex-smoker (for 12 months or longer)

Exclusion Criteria

  • •Poorly controlled asthma or seasonal asthma
  • •History of lower airway infection four weeks prior to visit 1
  • •Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
  • •Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
  • •Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
  • •Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
  • •Patients with chronic heart failure
  • •Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
  • •Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
  • •Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study

Outcomes

Primary Outcomes

change in lung function from baseline to final visit.

Secondary Outcomes

  • number of asthma exacerbations
  • safety.
  • pulmonary function variables
  • diary variables
  • quality of life variables
  • time to first exacerbation

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (41)

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