- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526357
Effect of Dietary Supplements With Fish Oil on Mannitol-induced Airway Sensitivity & Inflammation in Persons With Asthma
The Effect of Dietary Supplementation With Encapsulated Fish Oil on Mannitol-induced Airway Sensitivity and Inflammation in Persons With Asthma
Study Overview
Detailed Description
Asthma is a chronic inflammatory disorder of the airways characterized by recurrent episodes of dyspnea, wheeze and chest tightness and is associated with variable airway obstruction. Exercise-induced bronchoconstriction (EIB) is a feature specific to asthma. Exercise testing protocols have been developed to identify the presence of asthma as well as to assess asthma therapy. Airway narrowing following exercise in persons with asthma is thought to result from dry air hyperpnoea-induced dehydration of the airway surface, leading to the release of mediators from inflammatory cells residing in the airway. Regular treatment with inhaled corticosteroids inhibits the airway response to exercise by decreasing the number of inflammatory cells and thus the source of bronchoconstricting mediators. Therefore, a decrease in the source of mediator may be the reason for this eventual inhibition of the airway response to exercise.
It has recently been demonstrated that fish oil supplementation in capsule form, taken daily over three weeks, provides significant protection against EIB. This protection appears to be of equal or greater efficacy than inhaled corticosteroids treatment over a similar period. This may have positive implications in the treatment of asthma as inhaled corticosteroids are known to have some unwanted side effects. Fish oil supplementation in the high doses given in previous studies have not demonstrated any side effects and may lead to an alternative treatment, or a decrease in the dose of inhaled steroids required in the treatment of asthma.
A new bronchial provocation test using inhaled mannitol, derived from the mechanism of EIB, has been recently developed and is now registered in Australia and the European Union. Mannitol causes airway narrowing in a similar manner to exercise in persons with asthma and is effective in identifying responsiveness to inhaled corticosteroids. We wish to use inhaled mannitol as a model for EIB in an effort to further investigate the use of fish oil supplementation in the treatment of asthma. Our hypothesis is that daily orally administered encapsulated fish oil will attenuate the airway response to mannitol over a 3-week treatment period. We also wish to measure associated markers of inflammation in the blood, urine, sputum and exhaled condensate as well as monitor clinical outcomes such as symptoms and daily beta2 agonist use.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- Firestone Institute for Respiratory Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: A
Of the 24 asthmatic subjects, 12 will be enrolled who are taking beta2 agonists alone to treat their asthma
|
Pharmaceutical grade fish oil administered daily in the form of 10 capsules (5 capsules b.i.d.) each containing 400mg of eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA) which will equate to a daily dose of 4000 mg of EPA and 2000 mg or DHA.
The matched placebo containing a 50/50 mix of soybean and corn oil will be supplied by the same manufacturer (Ocean Nutrition, Canada)
Other Names:
|
OTHER: B
Of the 24 asthmatic subjects, 12 will be enrolled who are taking beta2 agonists and inhaled steroids to treat their asthma
|
Pharmaceutical grade fish oil administered daily in the form of 10 capsules (5 capsules b.i.d.) each containing 400mg of eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA) which will equate to a daily dose of 4000 mg of EPA and 2000 mg or DHA.
The matched placebo containing a 50/50 mix of soybean and corn oil will be supplied by the same manufacturer (Ocean Nutrition, Canada)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The cumulative dose of mannitol to cause a 15% reduction in FEV1 (PD15).
Time Frame: 3 weeks
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change following treatment in resting levels of eicosanoid metabolites in blood, urine & exhaled breath condensate (EBC). Sputum counts of eosinophils and metachromatic cells and LTB4, IL-a and TNF-a in sputum supernatant.
Time Frame: 3 weeks
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3 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paul M O'Byrne, MD, Firestone Institute for Respiratory Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.P. #06-2750
- Health Canada File No. 120532
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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