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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT07292805
Eligibility Criteria:
Inclusion Criteria:
* adult (\>18 years)
* severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical therapy (GINA treatment step 5; alternative diseases excluded, therapy compliance and adequate inhalation technique confirmed)
* 1 or more trials of treatment with a biologic or ineligible for biologic treatment
* 2 or more severe asthma exacerbations in the previous year (defined as the need for a course of OCS or doubling dose of maintenance OCS for at least 3 consecutive days)
* FEV1 ≥ 50% predicted after 400μg inhaled salbutamol or equivalent
Exclusion Criteria:
* chronic OCS therapy at a dose \>20 mg/day prednisone equivalent
* 1 or more ICU admission for mechanical or endotracheal intubation for
* asthma in the previous year.
* anti-coagulation therapy that cannot be stopped temporarily
* pregnancy
* body mass index ≥35
* current or ex-smokers with \>20 pack years
* DLCOc \<70%
* Subject has a known sensitivity to medications required to perform bronchoscopy
* Subject is using immunosuppressant therapy other than oral steroid therapy that impact on BT
* Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2 or known coagulopathy
* Comorbidities that are a contra-indication for BT such as severe heart failure and other respiratory diseases including bronchiectasis, interstitial lung disease, emphy-sema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (ABPA)
* Subject uses an internal or external pacemaker or cardiac defibrillator..
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07292805
Study Brief:
Protocol Section:
NCT07292805