Examination of Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation With Middle-chain and Polyunsaturated Fatty Acids in an Exercise-induced Asthma Provocation Model
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 73
- Locations
- 2
- Primary Endpoint
- Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo
Study Overview
Brief Summary
The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.
Detailed Description
Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. In a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature.
It is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators.
In this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model.
Therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation.
Before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. The investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to 44 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent
- •Patients: Age ≥12 and 44 years
- •known exercise induced asthma
- •basic lung function FVC ≥ 75%, FEV1 ≥ 70%
- •decrease in FEV1 after exercise ≥ 15%
Exclusion Criteria
- •lung function Forced vital capacity (FVC) <75% and Forced expiratory volume in 1 second (FEV1) <70%
- •chronic diseases or infections (e.g. HIV, Tbc)
- •pregnancy
- •systemic corticosteroid-treatment
- •inhalative corticosteroid therapy or leukotriene antagonists
- •alcohol, substance or drug abuse
- •inability to capture extend and consequences of the study
Outcomes
Primary Outcomes
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo
Time Frame: 4 weeks
The exercise challenge in cold air will be done on two timepoints. Before and after oil supplementation versus placebo supplementation. After exercise challenge spirometry will be measured. Decrease in FEV1 in verum and control group will be compared with t-test and Wilcoxon-Mann-Whitney-Test.
Secondary Outcomes
- Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)(4 weeks)
- Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)(4 weeks)
Investigators
Johannes Schulze MD
Consultant Pediatric Allergy and Pneumology
Johann Wolfgang Goethe University Hospital