Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Pfizer
Age
12–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
