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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT02948959
Eligibility Criteria:
Inclusion criteria :
Children 6 to \<12 years of age, with a physician diagnosis of persistent asthma for greater than or equal to (\>=)12 months prior to screening, based on clinical history and examination, pulmonary function parameters according to Global initiative for asthma (GINA) 2015 Guidelines and the following criteria:
* Existing background therapy of medium-dose ICS with second controller medication (i.e., long-acting β2 agonist , leukotriene receptor antagonist, long acting muscarinic antagonist, or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller, for at least 3 months with a stable dose \>=1 month prior to Screening Visit 1.
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) \<=95 percentage (%) of predicted normal or pre bronchodilator FEV1/forced vital capacity ratio \<0.85 at Screening and Baseline Visits.
* Reversibility of at least 10% in FEV1 after the administration of 200 to 400 micrograms (mcg; 2 to 4 puff inhalations with metered-dose inhaler \[MDI\]) of albuterol/salbutamol or 45 to 90 mcg (2 to 4 puffs with MDI) of levalbuterol/levosalbutamol reliever medication before randomization (up to 3 opportunities during the same visit were allowed with a maximum of 12 puffs of reliever medication if tolerated by the participant).
* Must had experienced, within 1 year prior to Screening Visit 1, any of the following events:
* Treatment with a systemic corticosteroid (oral or parenteral), as prescribed by a healthcare professional for worsening asthma at least once or,
* Hospitalization or emergency visit for worsening asthma.
* Evidence of uncontrolled asthma, with at least one of the following criteria during the 4 (±1) weeks Screening Period:
* Asthma Control Questionnaire-Interviewer Administered (ACQ-IA) ACQ-5 score \>=1.5 on at least one day of the Screening Period.
* Use of reliever medication (i.e., albuterol/salbutamol or levalbuterol/levosalbutamol), other than as a preventive for exercise induced bronchospasm, on 3 or more days per week, in at least one week during the Screening Period.
* Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening Period.
* Asthma symptoms 3 or more days per week in at least one week during the Screening Period.
Exclusion criteria:
* Participants \<6 or \>=12 years of age.
* Participants with \<16 kg bodyweight.
* Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc.), which may impair lung function.
* A participant with any history of life threatening asthma (ie, extreme exacerbation that requires intubation).
* Co-morbid disease that might interfere with the evaluation of investigational medicinal product.
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:
6 Years
Maximum Age:
11 Years
Study:
NCT02948959
Study Brief:
Protocol Section:
NCT02948959