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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT01056692
Eligibility Criteria:
Inclusion Criteria:
* Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
* FEV1 \>65% of predicted on at least two occasions at screening.
* At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive.
* No steroid usage in the past 12 weeks.
* Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
* Non smokers for a minimum of 6 months; less than 10 pack year history.
Exclusion Criteria:
* Respiratory tract pathology other than allergic asthma.
* Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
* Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01056692
Study Brief:
Protocol Section:
NCT01056692