Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00073177
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2003-11-17
• Study First Submitted QC: 2003-11-18
• Study First Posted: 2003-11-19
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 819

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)

Main

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in lung function from baseline to final visit.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ALTANA Pharma; 🇵🇪 Cities in Peru, Peru