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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT05137132
Eligibility Criteria:
Inclusion Criteria:
* Asthma Global Initiative for Asthma (GINA) treatment grade 2-4 (only standard care of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), no additional treatment except as-needed short--acting beta2-agonist (SABA)
* ACQ-5 score ≥0.75
* Diagnosed with asthma by medical doctor (general practitioner or pulmonary spesialist)
* Eosinophils ≥ 150 µL
* Speaks fluent Norwegian.
* For female in fertile age, use of contraception or other indication for non-pregnancy.
* Signed informed consent and expected cooperation of the participants for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
Exclusion Criteria:
* Treatment with oral corticosteroid \<1 month prior to baseline visit
* Treatment with any biological medication, \<6 months prior to baseline visit
* Oral/intravenous antibiotics \< 3 months prior to baseline visit
* Consumption of fish oil (liquid, capsule, powder) as an oral supplement \< 1-month prior baseline visit
* Known fish or shellfish allergy
* Pregnancy and breast feeding
* Participant in a confounding study
* Inflammatory bowel disease (Chron, ulcerative colitis (UC), microscopic colitis), celiac disease, or any chronic disease that possibly affects intestinal absorption and morbidity
* In case of severe cognitive impairment where the participants are not able to fulfill the study
* Not willing to participate
* Any reason why, in the opinion of the investigator, the participant cannot participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05137132
Study Brief:
Protocol Section:
NCT05137132