Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Exercise-induced Asthma

Treatments: Dietary Supplement: Oil supplementation placebo; Dietary Supplement: Oil supplementation verum; Other: Methacholine challenge; Other: Exercise challenge in a cold chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT02410096

KGU-360/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 12 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

Oil supplementation verum

Active Comparator group

Description:

30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach ones daily 1190 mg of middle-chain and polyunsaturated fatty acids for four weeks. Before and after supplementation an exercise challenge in a cold chamber will be performed.

Treatment:

Dietary Supplement: Oil supplementation verum

Other: Exercise challenge in a cold chamber

Other: Methacholine challenge

Oil supplementation placebo

Placebo Comparator group

Description:

30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach placebo for four weeks. Before and after placebo treatment an exercise challenge in a cold chamber will be performed.

Treatment:

Dietary Supplement: Oil supplementation placebo

Other: Exercise challenge in a cold chamber

Other: Methacholine challenge