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:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00712205
Eligibility Criteria:
Inclusion Criteria:
* 20 outpatients of either sex,
* ages ≥18 years, with a history of persistent asthma as defined by the American Thoracic Society (ATS) will be eligible for entry into the study.
* Additionally, patients must have been previously treated with ICS for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
* Patients will be required to have a forced expiratory volume in 1 s (FEV1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
* an improvement in FEV1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
* airway hyperresponsiveness to methacholine causing a 20% decline in FEV1 (PC20 FEV1) at a concentration of \< 16 mg/ml;
* diurnal peak expiratory flow (PEF) variability of ≥ 15% during at least 3 of 7 days before randomization.
Exclusion Criteria:
* Patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
* Also patients will not be eligible if they had \> 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required \> or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
* Patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-IgE (Xolair®).
* Patients with chronic obstructive pulmonary disease and current or former smokers of \>10 pack-years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00712205
Study Brief:
Protocol Section:
NCT00712205