NCT00375232

Brief Summary

The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

First QC Date

September 11, 2006

Last Update Submit

January 5, 2016

Conditions

Exercise-Induced Bronchospasm

Keywords

Exercise-Induced BronchospasmAsthmaCardiopulmonary Stress TestEucapnic Voluntary HyperventilationInduced sputum

Outcome Measures

Primary Outcomes (2)

  • Effective blunting of the EIB response by Spirometric measurement

  • Improvement in indices of ventilation and cardiopulmonary response measured on CPST

Interventions

Administration of montelukast or placeboDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • College level varsity athlete
  • age 18yr or older
  • healthy.
  • Able to swallow pills
  • No prior history of asthma

You may not qualify if:

  • Younger than 18yr
  • smoker
  • Prior history of asthma
  • Unable to swallow pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institue Of Fitness and Sport

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-InducedAsthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Mark O Farber, M.D.

    Indiana University School of Medicine Division of Pulmonary Critical Care and Occupational medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

October 1, 2006

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(1)