Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
12–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
