Asthma
Conditions
Brief summary
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
Interventions
DRUGRoflumilast
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in lung function from baseline to final visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| diary variables | — |
| quality of life variables | — |
| pulmonary function variables | — |
| number of asthma exacerbations | — |
| safety. | — |
| time to first exacerbation | — |
Countries
Argentina, Colombia, Mexico, Peru, United States
Outcome results
None listed