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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT02148120
Eligibility Criteria:
Inclusion Criteria:
* Patient's written informed consent obtained prior to any study-related procedures.
* Male or female aged between 18 and 65 years inclusive;
* Evidence for "partially controlled" or "uncontrolled" asthma;
* Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
* FEV1 between 60% and 85% of the predicted normal values;
* A documented positive response to the reversibility test;
* Non-smokers or ex-smokers;
* A cooperative attitude and ability to be trained in the proper use of a DPI.
Exclusion Criteria:
* Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
* Significant seasonal variation in asthma occurring or expected to occur during study participation;
* History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
* Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
* Diagnosis of Chronic Obstructive Pulmonary Disease;
* 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 8 weeks;
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
* Allergy, sensitivity or intolerance to study drugs or excipients;
* Patients who received any investigational drug within the last 8 weeks before the screening;
* Patients taking any of the non-permitted concomitant medication;
* Subjects unlikely to comply with the study protocol;
* Any clinically relevant abnormal value or physical finding at screening;
* Significant medical history;
* Abnormal and clinically significant 12-lead electrocardiogram;
* Patients with low compliance of QVAR intake.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02148120
Study Brief:
Protocol Section:
NCT02148120