Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204672
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
The Role of GER in Exercise Triggered Asthma
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
The Role of GER in Exercise Triggered Asthma
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HYPOTHESIS
Gastroesophageal reflux is a major contributor to exercise-triggered asthma
Two groups of patients will be studied those with asthma who have difficulty with exertion those without asthma who experience difficulty with exertion Both groups will experience gastroesophageal reflux GER twice of less per week Patients will complete a treadmill exam to determine their VO2 max They will then undergo pH monitoring while exercising for 30 minutes at 65-70 of their VO2 max Subjects will be given placebo or acid suppression pill for 12 weeks At the end of 12 weeks the subjects will repeat the exercise 30 minutes and 24-hour pH study
Gastroesophageal reflux is a major contributor to exercise-triggered asthma
Two groups of patients will be studied those with asthma who have difficulty with exertion those without asthma who experience difficulty with exertion Both groups will experience gastroesophageal reflux GER twice of less per week Patients will complete a treadmill exam to determine their VO2 max They will then undergo pH monitoring while exercising for 30 minutes at 65-70 of their VO2 max Subjects will be given placebo or acid suppression pill for 12 weeks At the end of 12 weeks the subjects will repeat the exercise 30 minutes and 24-hour pH study
Detailed Description:
PRIMARY OBJECTIVE
To determine whether patients with exercise-triggered asthma experience GER during exercise
SECONDARY OBJECTIVES
To determine whether the exercise-induced GER within the subjects relates temporally to their exertional asthma
To evaluate the efficacy of potent acid suppression with a proton pump inhibitor in suppressing exercise-triggered GER and asthma in these subjects
METHODS
Population to be evaluated
Exercise-triggered asthmatics - defined as asthmatics with exertion as their primary exacerbating factor and experiencing less than two episodes of classic gastroesophageal reflux a week
These patients will be randomized into three different treatment groups
1 Placebo BID
2 20 mg Aciphex QD and placebo QPM
3 20 mg Aciphex BID
12 patients will be studied in each group
DATA
pH data - Data will be collected on the frequency and duration of the reflux episodes number of episodes and the percent time the esophageal pH is less than 40 This will then be correlated with the respiratory symptom and changes in spirometry A symptom index will be designed to associate the episodes of reflux and bronchospasm that occur within 5 minutes of a drop in esophageal pH
Exercise ToleranceSymptoms - comparisons will be made between the three groups regarding symptomatology during exercise after randomization to either placebo or differing doses of Aciphex
Spirometry testing - done after exercise test Comparisons between baseline and following treatment Symptoms scores - both the overall numerical grades of the patients quality of life and the number of asthmatic episodes and rescue inhaler use will be compared to baseline after the 12 week study
STUDY DURATION
The asthma database at the University covers approximately 500 patients A database search will be performed to identify patients suitable for recruitment Additional recruitment if needed will be pursued through radio advertising Once the study is initiated the baseline time for therapy is 12 weeks for each patient An estimate of the time necessary to complete the study is 15 months
STATISTICS
Exercise triggered asthma has not been well studied with respect to its relationship to GER This study will be considered a pilot study with 12 subjects per arm Results from this study may be used to power a follow up study
To determine whether patients with exercise-triggered asthma experience GER during exercise
SECONDARY OBJECTIVES
To determine whether the exercise-induced GER within the subjects relates temporally to their exertional asthma
To evaluate the efficacy of potent acid suppression with a proton pump inhibitor in suppressing exercise-triggered GER and asthma in these subjects
METHODS
Population to be evaluated
Exercise-triggered asthmatics - defined as asthmatics with exertion as their primary exacerbating factor and experiencing less than two episodes of classic gastroesophageal reflux a week
These patients will be randomized into three different treatment groups
1 Placebo BID
2 20 mg Aciphex QD and placebo QPM
3 20 mg Aciphex BID
12 patients will be studied in each group
DATA
pH data - Data will be collected on the frequency and duration of the reflux episodes number of episodes and the percent time the esophageal pH is less than 40 This will then be correlated with the respiratory symptom and changes in spirometry A symptom index will be designed to associate the episodes of reflux and bronchospasm that occur within 5 minutes of a drop in esophageal pH
Exercise ToleranceSymptoms - comparisons will be made between the three groups regarding symptomatology during exercise after randomization to either placebo or differing doses of Aciphex
Spirometry testing - done after exercise test Comparisons between baseline and following treatment Symptoms scores - both the overall numerical grades of the patients quality of life and the number of asthmatic episodes and rescue inhaler use will be compared to baseline after the 12 week study
STUDY DURATION
The asthma database at the University covers approximately 500 patients A database search will be performed to identify patients suitable for recruitment Additional recruitment if needed will be pursued through radio advertising Once the study is initiated the baseline time for therapy is 12 weeks for each patient An estimate of the time necessary to complete the study is 15 months
STATISTICS
Exercise triggered asthma has not been well studied with respect to its relationship to GER This study will be considered a pilot study with 12 subjects per arm Results from this study may be used to power a follow up study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None