Status:
COMPLETED
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Pfizer
Conditions:
Asthma
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief 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 t...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
- The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
- FEV1 between 60 and 90% predicted at visit 1
- No change in asthma treatment within 4 weeks prior to visit 1
- Main
Exclusion
- Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
- Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
- A history of lower airway infection in the four weeks prior to visit 1
- A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
- Heavy smoker currently smoking \>20 cigarettes per day and/or \>10 pack years or the patient is an ex-smoker who has smoked \>10 pack years
- Patients using \>8 puffs/day relief medication regularly prior to visit 1
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
- Patients with chronic heart failure class III or IV (New York Heart Association)
- Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
- A history of alcoholism or substance abuse within the 12 months prior to visit 1
- Pregnancy or women of childbearing potential who are not using a reliable method of contraception
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
2054 Patients enrolled
Trial Details
Trial ID
NCT00163527
Start Date
April 1 2003
End Date
November 1 2005
Last Update
December 2 2016
Active Locations (24)
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1
ALTANA Pharma
Cities in Georgia, Georgia, United States
2
ALTANA Pharma
Cities in Austria, Austria
3
ALTANA Pharma
Cities in Croatia, Croatia
4
ALTANA Pharma
Cities in the Czech Repulik, Czechia