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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00712335
Eligibility Criteria:
Inclusion Criteria:
Asthmatics:
* clinical history of asthma for at least 1 year
* with evidence of reversible airway obstruction,
* two documented FEV1 between 60-85%,
* PC20 \< 4mg/ml by methacholine challenge test
* and average baseline β-agonist use of 2 puffs/day
Smokers:
* smoke 1/2 to 2 packs a day
* with a smoking history of 5-30 pack years
Non-smokers:
* Non-smokers will have either never smoked or have stopped smoking cigarettes over 5 years ago
Exclusion Criteria:
* positive HCG (for females)
* have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks
* history of COPD or respiratory disorder other than asthma
* history of psychiatric illness
* allergy to fluticasone propionate, salmeterol, montelukast or any of their components
* significant, unstable medical condition other than asthma
* history of life-threatening asthma exacerbation requiring intubation and mechanical ventilation in the last ten years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00712335
Study Brief:
Protocol Section:
NCT00712335