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Completed

NCT Number: NCT02410096

Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

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.

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Key information

Conditions

Exercise-induced Asthma Asthma Asthma, Exercise-Induced Bronchial Diseases Exercise-Induced Allergies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise challenge in a cold chamber

Other

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.

Methacholine challenge

Other

Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg

Oil supplementation verum

Dietary Supplement

Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks

Oil supplementation placebo

Dietary Supplement

Patients and subjects will take double blind sunflower oil for four weeks

Primary outcomes

  1. 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

  1. Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)

    Time frame: 4 weeks

    Comparison of decrease in eNO before and after supplementation in verum and placebo group

  2. Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)

    Time frame: 4 weeks

    Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group

Other outcomes

  1. Comparison of two methods of lung function testing as measured by spirometry (FEV1, percent predicted) and body plethysmography (specific airway resistance, sRAW, kPa*sec)

    Time frame: 4 weeks

    Both methods will be done in parallel before and 4 times after exercise challenge in cold air. Afterwards the investigators can compare both methods and calculate the sensitivity for both methods to indicate exercise induced bronchoconstriction.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Examination of Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation With Middle-chain and Polyunsaturated Fatty Acids in an Exercise-induced Asthma Provocation Model

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2015
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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