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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02573233
Eligibility Criteria:
Inclusion criteria:
* Male and female adults with a physician diagnosis of persistent asthma for ≥12 months.
* Existing treatment with medium to high dose inhaled corticosteroids in combination with a long-acting beta agonist for at least 3 months with a stable dose ≥1 month prior to Visit 1 (Screening Visit).
* Treatment with a third asthma controller for at least 3 months with a stable dose \>=1 month prior to Visit 1 was allowed.
* Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.
Exclusion criteria:
* Participants \<18 years or \>65 years.
* Fractional exhaled nitric oxide (FeNO) \<26 parts per billion (ppb) at Visit 1 (Screening Visit).
* Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis \[Churg-Strauss Syndrome\]) which could impair lung function.
* A participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
* A participant who had experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.
* Evidence of lung disease(s) other than asthma.
* Previous smoker (smoking history \>10 pack-years) or current smoker (within 6 months prior to Visit 1).
* Comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (e.g., bronchoscopy).
* Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within 6 months of Visit 1.
* Exposure to another investigative study medication within a time period prior to Visit 1 that is less than 5 half-lives of the study medication.
* Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit 1.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02573233
Study Brief:
Protocol Section:
NCT02573233