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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT00526357
Eligibility Criteria:
Inclusion Criteria:
* Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
* Stable, mild atopic asthma with forced expiratory volume in one second (FEV1) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta2-agonists as required or for those on steroids, taking \< 1000 mcg of inhaled corticosteroid per day.
* No recent or significant history of cigarette smoking (no smoking within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
* Signed written informed consent to participate in the study; ability to return to the clinic for repeated visits.
* No history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a four week period preceding entry into the screening phase of the study.
* Subjects who take inhales steroids regularly must demonstrate reproducibility to inhaled mannitol (PD15\<1.0 doubling doses) during a 2 week run-in period.
* A PD15 to the mannitol challenge \< 315mg
Exclusion Criteria:
* Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular, metabolic such as including type II diabetes or other body system disorder.
* Regular consumption of fish consisting more than 1 meal of fish per week or regular fish oil supplements during the trial and for at least 2 weeks prior to the first study visit.
* Subjects who have taken oral corticosteroids or a leukotriene receptor antagonist in 4 weeks prior to entry into the study.
* Psychosis, alcoholism, active substance abuse, or any personality disorder, which would make compliance with this protocol problematic.
* Pregnant or nursing females.
* Any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.
* Subjects taking \>1000 mcg of inhaled steroids daily in those subjects taking inhaled steroids.
* Subjects requiring regular anti-histamines for allergies.
* Subjects who have allergy to fish or any other ingredient in the study products.
* Subjects using anti-coagulants (warfarin, heparin)
* Subjects who have surgery planned over the course of the trial.
* Subjects who use medications to lower LDL cholesterol levels
* Subjects using non-steroidal anti-inflammatory medications (e.g., aspirin, ibuprofen)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00526357
Study Brief:
Protocol Section:
NCT00526357