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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT04193150
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-74 at the time of signing the informed consent form.
2. Physician diagnosed asthma.
3. Active treatment
1. Defined as minimum 1 filled prescription of an obstructive pulmonary disease drug (ACT R03) during the last 12 months.
2. Dosage of ICS as described in the NICE guidelines.
4. No asthma-related contact to a respiratory medicine outpatient clinic during the last 36 months.
Exclusion Criteria:
1. Inability to give informed consent.
2. Inability to participate in questionnaires during the 12 months follow-up. Note: follow-up questionnaires can be provided in printed form, should the patient not have internet access.
3. Inability to participate in baseline spirometry, blood sampling and skin prick test.
4. Inability to abstain from pre-assessment meals and caffeine (2 hours), smoking (same day), ICS (1 day) and bronchodilators (24 hours).
5. Any clinically important concomitant severe pulmonary disease such as COPD without an asthmatic/significant reversible component, pulmonary fibrosis, cystic fibrosis, lung cancer, previous lobectomy, alpha 1 anti-trypsin deficiency, primary ciliary dyskinesia, allergic aspergillosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT04193150
Study Brief:
Protocol Section:
NCT04193150