Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Glenmark Pharmaceuticals Europe Ltd. (R&D)
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eligibility Criteria:
Adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an FEV1 of 60% to 85% of the predicted value).
The following criteria must be met at the randomisation visit:
At least 80% compliance during the single-blind placebo run-in period
FEV1 between 60% and 85% of the predicted value
Without asthma exacerbation during the run-in period
Reversibility: patients are required to demonstrate a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer
Any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in
Use of salbutamol for symptom relief on \> 2 occasions on at least 4 out of the last 7 days of the run-in