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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT03034005
Eligibility Criteria:
Inclusion Criteria:
* Asthma as defined by GINA (www.ginasthma.org) Eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) \> 25 ppb (marker of eosinophilic airway inflammation) Non-eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) \< 25 ppb
* An FEV1 value of ≥70% of expected
* Airway hyperresponsiveness to mannitol (PD15 ≤ 315 mg)
* Not treated with oral or inhaled steroids (past 3 months)
Exclusion Criteria:
* Smoking (current smokers or a maximum of 10 pack years)
* Competing respiratory diseases
* Lower respiratory tract infection within the past 4 weeks
* Medical history with significant comorbidity (ASA\>2)
* Pregnant or breastfeeding
* Hypersensitivity to study medication including Spirocort, Osmohale, Midazolam or Fentanyl
* Uncontrolled hypertension
* Acute myocardial infarction within past 6 months
* Aorta- or cerebral aneurism
* Recent abdominal operation
* Failure to comply with study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03034005
Study Brief:
Protocol Section:
NCT03034005