Status:
COMPLETED
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
Lead Sponsor:
AstraZeneca
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 bronchial asthma (with reference to the Global Initiative for Asthma Guidelines 2002)
- Baseline FEV1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, DSCG, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination
- Baseline FEV1 60 - 90% in patients receiving not more than 500 mcg BDP-CFC (or equivalent) and/or in combination with any other asthma medication mentioned above
- No change in the asthma treatment 4 weeks prior to baseline period
- Patients who, with the exception of asthma, are in good health
- Main
Exclusion
- Poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
- Patient using regularly \>8 puffs/day rescue medication prior to baseline
- History of lower airway infection in the last 4 weeks prior to baseline period
- Diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
- Heavy smoker: currently: \>20 cigarettes/day and/or \>10 pack years, ex-smoker: with a smoking history of ≥10 pack years
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- Liver insufficiency (Child Pugh A or worse)
- Active hepatitis
- Known infection with HIV
- Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
- Alcohol and/or drug abuse
- Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
- Pregnancy or patient of childbearing potential who is not using reliable method of contraception
- Patients not able to follow study procedures, e.g. due to language problems, psychological disorders
- Suspected inability or unwillingness to comply with the study procedures
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT00163475
Start Date
May 1 2004
End Date
August 1 2005
Last Update
October 25 2016
Active Locations (5)
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1
ALTANA Pharma
Cities in Australia, Australia
2
ALTANA Pharma
Cities in Belgium, Belgium
3
ALTANA Pharma
Cities in France, France
4
ALTANA Pharma
Cities in South Africa, South Africa