Status:
COMPLETED
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
819 Patients enrolled
Trial Details
Trial ID
NCT00073177
Start Date
November 1 2003
Last Update
October 25 2016
Active Locations (41)
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1
ALTANA Pharma
Cities in Alabama, Alabama, United States
2
ALTANA Pharma
Cities in Arizona, Arizona, United States
3
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
4
ALTANA Pharma
Cities in California, California, United States