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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00862394
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Outpatients of both sexes, aged \> 12 years
* Moderate to severe symptomatic asthma
* Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values
* Reversibility test
* "Partly controlled" asthma (GINA revised 2006)
* Patients free of long-acting beta2-agonists (LABAs) treatment
* Under inhaled corticosteroids (ICS) treatment
* A minimum inspiratory flow ≥ 40 L/min 10.
* Non-smokers or ex smokers
* Asthma Control Questionnaire ACQ score ≥ 1.5
Exclusion Criteria:
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
* Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
* History of near fatal asthma
* Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
* Diagnosis COPD
* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
* Diagnosis of restrictive lung disease
* Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
* Allergy to any component of the study treatments
* Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
* Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
* Patients with abnormal QTc
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00862394
Study Brief:
Protocol Section:
NCT00862394