Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT00859404
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00859404
Study Brief:
Protocol Section:
NCT00859404