Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Not Applicable

Completed

• Conditions: Exercise-induced Asthma

• Registration Number: NCT02410096
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

The investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.

Study Timeline

• Study First Submitted: 2015-03-18
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-07
• Primary Completion: 2016-02
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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
• smokers
• inability to capture extend and consequences of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo	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 Outcome Measures

Name	Time	Method
Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)	4 weeks	Comparison of decrease in eNO before and after supplementation in verum and placebo group
Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)	4 weeks	Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group

Trial Locations

Locations (1)

Goethe University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany