Exercise Triggered AsthmaPhase 1NCT00444236
Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression
A Phase 1 study testing Nexium in people with Exercise Triggered Asthma and Gastroesophageal Reflux, run by University of Utah at 1 site in United States.
Trial summary
We propose that acid reflux affects respiratory dynamics (breathing) in patients who are exercising and that athletes improve their exercise capacity with acid suppression therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Triggered Asthma, Gastroesophageal Reflux
- What is being tested?
- Nexium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We plan to take athletes (cyclists) with GER (heartburn symptoms on a daily-weekly basis which are either improved by a trial of acid suppression or objectively documented via pH/endoscopic testing- this may include during exercise) who experience one or more of the following symptoms during exercise, limiting their perceived ability to exercise to full capacity:
- choking
- cough
- wheezing
- shortness of breath
- chest tightness during exercise
- Athletes will be defined as persons who exercise on a routine basis (at least 3 times a week on average) for at least the past 6 months.
- Subjects must be at least 18 years old.
Who cannot join
- Pregnancy
- Age less than 18 years or greater than 65 years
- Abnormal methacholine challenge tests will not exclude one from enrollment as (has been documented in a prior study) often patients with GER will have heightened bronchial reactivity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
We propose that acid reflux affects respiratory dynamics (breathing) in patients who are exercising and that athletes improve their exercise capacity with acid suppression therapy. It is our intent to determine whether treatment of GER with strong acid suppression may alleviate symptoms, improve exercise capacity, and improve quality of life.
Read the detailed description
This is a randomized, blinded, cross-over trial. We plan to take athletes with classical GER, cough, shortness of breath, chest tightness during exercise and subject them to complete pulmonary function testing in conjunction with exercise and pH testing. We will assess whether such athletes experience an increase in reflux duration and episodes during exercise. The athletes will be randomized (in a cross over fashion) to acid suppression (BID Nexium 40 mg) or placebo for 10-12 weeks. Both the athletes and investigators will be blinded. After 10-12 weeks, exercise testing (ramp protocol with VO2 and anaerobic threshold) with concurrent respiratory function testing will be repeated along with symptom assessment. After a brief washout period of 1-2 weeks, the athletes will then cross-over to the other study medication for 10-12 weeks. Again, at the end of the study period, symptomatic relief as well as respiratory function improvement will be assessed by repeating the initial exercise regimen. The exercise regimens during these medication regimens will not be held stable as indirectly, as a results of "feeling better or worse" from the medication/placebo, these patients may increase/ decrease their exercise routine, resulting in changes in their overall endurance, anaerobic threshold, etc (our endpoints). By keeping the regimen stable, we do not allow for the changes to occur which are large enough to detect.
- Conditions
- Exercise Triggered Asthma, Gastroesophageal Reflux
- Being tested
- Nexium, Placebo
- Keywords
- asthma, GERD, reflux, exercise
- Medical subject headings
- Gastroesophageal Reflux, Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexiumDrug
Also called esomeprazole
nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
PlaceboDrug
matching placebo for active drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Nexium |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients.
Measured: 6 months
Secondary outcomes (2)
To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion.
Measured: 6 months
To assess whether long term acid suppression results in enhanced athletic performance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: The sponsor decided to terminate the study due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Triggered AsthmaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Kathryn A. Peterson, University of Utah
- Investigators
- Kathryn A Peterson, MD, MSci, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444236
- Sponsor's protocol ID
- IRB # 20135
- Other IDs
- Exercise/Asthma
- Status last verified
- Jan 2016
- First submitted
- 6 Mar 2007
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression
- ClinicalTrials.gov ID
- NCT00444236
- Acronym / sponsor ID
- IRB # 20135
- Conditions
- Exercise Triggered Asthma, Gastroesophageal Reflux
- Keywords
- asthma, GERD, reflux, exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to terminate the study due to slow enrollment.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose that acid reflux affects respiratory dynamics (breathing) in patients who are exercising and that athletes improve their exercise capacity with acid suppression therapy. It is our intent to determine whether treatment of GER with strong acid suppression may alleviate symptoms, improve exercise capacity, and improve quality of life.
Detailed description
This is a randomized, blinded, cross-over trial. We plan to take athletes with classical GER, cough, shortness of breath, chest tightness during exercise and subject them to complete pulmonary function testing in conjunction with exercise and pH testing. We will assess whether such athletes experience an increase in reflux duration and episodes during exercise. The athletes will be randomized (in a cross over fashion) to acid suppression (BID Nexium 40 mg) or placebo for 10-12 weeks. Both the athletes and investigators will be blinded. After 10-12 weeks, exercise testing (ramp protocol with VO2 and anaerobic threshold) with concurrent respiratory function testing will be repeated along with symptom assessment. After a brief washout period of 1-2 weeks, the athletes will then cross-over to the other study medication for 10-12 weeks. Again, at the end of the study period, symptomatic relief as well as respiratory function improvement will be assessed by repeating the initial exercise regimen. The exercise regimens during these medication regimens will not be held stable as indirectly, as a results of "feeling better or worse" from the medication/placebo, these patients may increase/ decrease their exercise routine, resulting in changes in their overall endurance, anaerobic threshold, etc (our endpoints). By keeping the regimen stable, we do not allow for the changes to occur which are large enough to detect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Nexium |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- We plan to take athletes (cyclists) with GER (heartburn symptoms on a daily-weekly basis which are either improved by a trial of acid suppression or objectively documented via pH/endoscopic testing- this may include during exercise) who experience one or more of the following symptoms during exercise, limiting their perceived ability to exercise to full capacity:
- Athletes will be defined as persons who exercise on a routine basis (at least 3 times a week on average) for at least the past 6 months.
- Subjects must be at least 18 years old.
Key exclusion criteria (3 listed)
- Pregnancy
- Age less than 18 years or greater than 65 years
- Abnormal methacholine challenge tests will not exclude one from enrollment as (has been documented in a prior study) often patients with GER will have heightened bronchial reactivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexiumAlso: esomeprazolenexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks | Drug | 1 |
| Placebomatching placebo for active drug | Drug | 2 |
Primary outcome
To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients.
Time frame: 6 months
2 secondary outcomes
To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion.
Time frame: 6 months
To assess whether long term acid suppression results in enhanced athletic performance
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The sponsor decided to terminate the study due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn A Peterson, MD, MSci principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nexium in people with Exercise Triggered Asthma and Gastroesophageal Reflux, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The sponsor decided to terminate the study due to slow enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.