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Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes (STAMINA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01691079
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bronchospasm, Exercise-Induced
Interventions Drug: ipratropium bromide
Drug: Placebo
Enrollment 20
Recruitment Details PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Pre-assignment Details  
Arm/Group Title Placebo Ipratropium Bromide
Hide Arm/Group Description

placebo 2 puffs prior to exercise challenge

Placebo: Inhaled placebo administered before exercise.

ipratropium bromide HFA 2 puffs prior to exercise challenge

ipratropium bromide: Inhaled ipratropium bromide administered before exercise.

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Placebo Ipratropium Bromide Total
Hide Arm/Group Description

placebo 2 puffs prior to exercise challenge

Placebo: Inhaled placebo administered before exercise.

ipratropium bromide HFA 2 puffs prior to exercise challenge

ipratropium bromide: Inhaled ipratropium bromide administered before exercise.

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race and Ethnicity Not Collected   [1] 
Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame The outcome measures will be assessed over an expected average of 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Arm/Group Title Placebo Ipratropium Bromide
Hide Arm/Group Description:

placebo 2 puffs prior to exercise challenge

Placebo: Inhaled placebo administered before exercise.

ipratropium bromide HFA 2 puffs prior to exercise challenge

ipratropium bromide: Inhaled ipratropium bromide administered before exercise.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Specific IgE Measurements
Hide Description [Not Specified]
Time Frame The outcome measures will be assessed over an expected average of 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Arm/Group Title Placebo Ipratropium Bromide
Hide Arm/Group Description:

placebo 2 puffs prior to exercise challenge

Placebo: Inhaled placebo administered before exercise.

ipratropium bromide HFA 2 puffs prior to exercise challenge

ipratropium bromide: Inhaled ipratropium bromide administered before exercise.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
 
Arm/Group Title Placebo Ipratropium Bromide
Hide Arm/Group Description

placebo 2 puffs prior to exercise challenge

Placebo: Inhaled placebo administered before exercise.

ipratropium bromide HFA 2 puffs prior to exercise challenge

ipratropium bromide: Inhaled ipratropium bromide administered before exercise.

All-Cause Mortality
Placebo Ipratropium Bromide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Placebo Ipratropium Bromide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ipratropium Bromide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mona Luke-Zeitoun, MD
Organization: University of California, San Francisco
EMail: lukezeitounm@peds.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01691079    
Other Study ID Numbers: 12-09621
First Submitted: September 13, 2012
First Posted: September 24, 2012
Results First Submitted: May 20, 2020
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020