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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT02404103
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of asthma
* Informed consent by parent or legal guardian
* 6 years to 18 years of age at screening visit
* ability to comply with medication use, study visits and study procedures as judged by the site investigator
* FEF 25-75% \<65% of predicted as a marker for small airway disease
Exclusion Criteria:
* Acute wheezing at screening visit or at Baseline visit
* Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit
* Oxygen saturation \<95% at screening visit or at Baseline visit
* Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.
* Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
* Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
* Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days
* Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma
* Potential subjects who are pregnant may not enroll in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT02404103
Study Brief:
Protocol Section:
NCT02404103