Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes

NCT01691079 | Completed Phase 4 Results

• 1 other identifier: 12-09621
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.

Conditions

Bronchospasm, Exercise-Induced

Outcome Measures

Primary Outcomes (1)

• Spirometry and Specific Airway Conductance Measured by Body Plethysmography Before and After Exercise Challenge After Randomized Administration of Either Inhaled Ipratropium Bromide or Inhaled Placebo

  The outcome measures will be assessed over an expected average of 6 months.

Secondary Outcomes (1)

• Specific IgE Measurements

  The outcome measures will be assessed over an expected average of 6 months.

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo 2 puffs prior to exercise challenge

Drug: Placebo

ipratropium bromide

ACTIVE COMPARATOR

ipratropium bromide HFA 2 puffs prior to exercise challenge

Drug: ipratropium bromide

Interventions

ipratropium bromide DRUG

Inhaled ipratropium bromide administered before exercise.

Also known as: atrovent

ipratropium bromide

Placebo DRUG

Inhaled placebo administered before exercise.

placebo

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Athletes \> 13 years of age

You may not qualify if:

• History of cardiac complaints (chest pain, shortness of breath, palpitations, dyspnea on exertion).
• History of cardiac disease or taking cardioactive medications.
• History of smoking.
• History of glaucoma.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Mona Luke-Zeitoun, MD
• Organization: University of California, San Francisco

lukezeitounm@peds.ucsf.edu

Study Officials

• Mona Luke-Zeitoun

  Assistant Clinical Professor (Volunteer)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 24, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 5, 2020
• Results First Posted: June 5, 2020

Record last verified: 2020-05

Locations

US (1)