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

• 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: University of California, San Francisco
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Placebo	Ipratropium Bromide	Total
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
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

Outcome Measures

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
Description	[Not Specified]
Time Frame	The outcome measures will be assessed over an expected average of 6 months.

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	The outcome measures will be assessed over an expected average of 6 months.

Outcome Measure Data

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
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.

Adverse Events

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
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
Serious Adverse Events
	Placebo	Ipratropium Bromide
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Mona Luke-Zeitoun, MD
• Organization: University of California, San Francisco
• EMail: lukezeitounm@peds.ucsf.edu

• 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