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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT05168995
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥18 years;
2. Patients enrolled on the same day as the first prescription with BDP/FF NEXThaler® 100/6 micrograms, or having ongoing treatment with BDP/FF NEXThaler® 100/6 micrograms started within the previous 14 days (maximum), as per local standard clinical practice.
3. Not adequately controlled asthmatic patients (according to clinician's judgement) when BDP/FF NEXThaler® 100/6 micrograms was prescribed;
4. Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF NEXThaler®;
5. Written informed consent to participate in the study and for the processing of personal data.
Exclusion Criteria:
1. Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations;
2. Diagnosis of chronic obstructive pulmonary disease (COPD);
3. Asthmatic patients on treatment with biologic agents (e.g. monoclonal antibodies) and/or extemporary or fixed triple combinations (e.g. long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA)/inhaled corticosteroid (ICS) at any dose regimen;
4. Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires;
5. Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05168995
Study Brief:
Protocol Section:
NCT05168995