Elite Sport and Development of Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-12-31

Brief Summary

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International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". The treatment of elite athletes with asthma seems to vary widely, and only a few studies have focused on the treatment of elite athletes with asthma. Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding and better treatment of the condition. This study will investigate the type of airway inflammation in elite athletes and examine the effect of treatment with inhaled steroids in combination with long-acting beta-agonists versus placebo in the same group.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo inhaler (sugar powder)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inhaled sugar powder in a placebo inhaler

Seretide

Seretide inhaler

Group Type ACTIVE_COMPARATOR

Seretide

Intervention Type DRUG

Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)

Interventions

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Seretide

Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr)

Intervention Type DRUG

Placebo

Inhaled sugar powder in a placebo inhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elite athletes
* Informed consent
* Doctor diagnosed asthma

Exclusion Criteria

* Current smoker or more than 10 pack-years
* Pregnancy, breast feeding or planning pregnancy during the study.
* ICS within the last 4 weeks prior to visit 1.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes