AsthmaPhase 3NCT00214552
Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.
A Phase 3 study testing rabeprazole in people with Asthma and Gastroesophageal Reflux Disease, run by Associated Scientists to Help Minimize Allergies at 2 sites in United States.
Trial summary
The hypothesis for this study is that potent anti-secretory therapy with high dose PPI improves asthma control regardless of either asthma severity or the presence of GERD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma, Gastroesophageal Reflux Disease
- What is being tested?
- rabeprazole
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Mar 2005
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be 18 years of age or older.
- Subjects baseline FEV1 must be greater than or equal to 50% of predicted at both Visit 1 and visit 2, when all bronchodilators medications have been withheld for the specified intervals.
- Subjects must have physician-diagnosed asthma at visit 1 and report ongoing chronic or intermittent symptoms that include at least one of the following: wheezing, chest tightness, dyspnea, or cough.
- All subjects with a baseline FEV1 greater than or equal to 70% predicted must have a positive methacholine challenge (provocative dose required to reduce FEV1 20% is less than or equal to 10 mg inhaled methacholine) at either visit 1 or visit 2.
- All subjects with a baseline FEV1 greater than 50% but less than 70% must demonstrate at least 12% improvement in FEV1 after a bronchodilator is administered at visit 1 or visit 2.
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- Subjects must report using rescue inhaled beta adrenergic agonist treatment at least twice weekly for asthma symptoms (e.g. 2 or more nebulized treatments or 4 or more puffs of inhaled albuterol per week).
- Subjects must experience asthma symptoms (wheezing, shortness of breath, cough, chest tightness, or nocturnal awakening) of at least mild severity on at least 2 days out of each week of run-in (1 week equals 7 days). In addition, the asthma symptom diary card score (over a two week period) must total at least 10 as recorded by the study subject in the run-in diary card. The run-in period may vary in length from 7 days to 28 days, as long as the 10 point score is achieved in a 10 day period.
- Subjects must be free of any clinically significant disease other than asthma.
- Women of childbearing potential must have a negative urine (hCG) pregnancy test at visit 1 or visit 2 and agree, if sexually active, to use medically accepted contraception as defined in ICH guidelines throughout the study.
- Subjects must agree to have the investigator inform their usual treating physician (if other than the study investigator) of their participation in the study.
Who cannot join
- Female subjects who are pregnant or lactating.
- Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 21 days during the 6 months immediately prior to Visit 1.
- Subjects who require daily treatment with proton pump inhibitors, H2-receptor antagonists, or OTC anti-reflux medications).
- Subjects on immunotherapy, unless they are on a stable maintenance schedule for at least 6 months.
- Subjects who have used any investigational drug in the 30 days prior to visit 1.
- Subjects who have experienced allergic or idiosyncratic reactions to PPI, corticosteroid, or inhaled beta adrenergic agonist agents.
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- Subjects demonstrating a change in FEV1 of 20% or more between visit 1 and 2.
- Subjects who have required ventilatory support for respiratory failure due to asthma within 5 years of Visit 1.
- Subjects who smoke, have smoked within the past 6 months, or have more than a 15 pack-year history of smoking.
- Subjects who have required hospitalization for asthma in the previous 3 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ASTHMA, Inc.
Richland, Washington, 99352
ASTHMA, Inc.
Seattle, Washington, 98105
About this study
Official title: A Double-blind Placebo Controlled Clinical Trial to Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.
The hypothesis for this study is that potent anti-secretory therapy with high dose PPI improves asthma control regardless of either asthma severity or the presence of GERD symptoms.
Read the detailed description
Many patients with GERD do not experience heartburn symptoms. Barium esophagram, endoscopy and/or overnight esophageal pH monitoring are commonly relied upon to objectively establish the diagnosis of GERD. In general, overnight esophageal pH monitoring is the most sensitive and specific test available to confirm GERD. However, the literature exploring GERD as a cause of chronic cough suggests that the currently accepted criteria for defining abnormal overnight esophageal pH may not be adequately sensitive. It is therefore possible that aggressive GERD therapy may improve asthma control in patients with "normal" overnight esophageal pH probe results. To our knowledge, there are no published data addressing this question.
Primary Objective The primary objective is to compare asthma control in asthmatic subjects treated with high dose PPI with asthmatic subjects taking placebo PPI. The primary outcome variables will be measurements of asthma symptoms and asthma quality of life.
Secondary Objectives Secondary objectives include evaluating the effect of this aggressive anti-secretory therapy on lung function, asthma medication use (including both baseline and rescue medication), and GERD symptoms. An additional secondary objective will be to evaluate whether the presence or absence of GERD symptoms at baseline (prior to proton pump inhibitor therapy) will independently associate with improvement in any of the other outcomes measured.
Measurements will include: Juniper Asthma Control Questionnaire (visits 2 and 5), Juniper Asthma Quality of Life Questionnaire (visits 2 - 5), GSAS gastroesophageal reflux instrument (visit 2, visit 5), the occurrence of adverse events, change in FVC, FEF25-75%, MIF50 / MEF50, peak expiratory flow rate, FEV1 reversibility, and the physical exam.
Additional measurements will include methacholine challenge and eosinophilia in induced sputum specimens. Induced sputum will be offered to all patients, though it is anticipated that only approximately 50% will agree to this procedure.
- Conditions
- Asthma, Gastroesophageal Reflux Disease
- Being tested
- rabeprazole
- Keywords
- GERD, Gastroesophageal reflux disease, Asthma symptoms
- Medical subject headings
- Asthma, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma symptoms
Secondary outcomes (1)
Asthma quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associated Scientists to Help Minimize Allergies
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals, Eisai Inc.
- Investigators
- Stephen A Tilles,, MD, Principal investigator, ASTHMA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214552
- Sponsor's protocol ID
- RAB-USA-38
- Status last verified
- Jun 2011
- First submitted
- 10 Sep 2005
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo Controlled Clinical Trial to Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.
- ClinicalTrials.gov ID
- NCT00214552
- Acronym / sponsor ID
- RAB-USA-38
- Conditions
- Asthma, Gastroesophageal Reflux Disease
- Keywords
- GERD, Gastroesophageal reflux disease, Asthma symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Associated Scientists to Help Minimize AllergiesUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals, Eisai Inc.
- Study start
- Sep 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 22 Sep 2005 (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.
The hypothesis for this study is that potent anti-secretory therapy with high dose PPI improves asthma control regardless of either asthma severity or the presence of GERD symptoms.
Detailed description
Many patients with GERD do not experience heartburn symptoms. Barium esophagram, endoscopy and/or overnight esophageal pH monitoring are commonly relied upon to objectively establish the diagnosis of GERD. In general, overnight esophageal pH monitoring is the most sensitive and specific test available to confirm GERD. However, the literature exploring GERD as a cause of chronic cough suggests that the currently accepted criteria for defining abnormal overnight esophageal pH may not be adequately sensitive. It is therefore possible that aggressive GERD therapy may improve asthma control in patients with "normal" overnight esophageal pH probe results. To our knowledge, there are no published data addressing this question.
Primary Objective The primary objective is to compare asthma control in asthmatic subjects treated with high dose PPI with asthmatic subjects taking placebo PPI. The primary outcome variables will be measurements of asthma symptoms and asthma quality of life.
Secondary Objectives Secondary objectives include evaluating the effect of this aggressive anti-secretory therapy on lung function, asthma medication use (including both baseline and rescue medication), and GERD symptoms. An additional secondary objective will be to evaluate whether the presence or absence of GERD symptoms at baseline (prior to proton pump inhibitor therapy) will independently associate with improvement in any of the other outcomes measured.
Measurements will include: Juniper Asthma Control Questionnaire (visits 2 and 5), Juniper Asthma Quality of Life Questionnaire (visits 2 - 5), GSAS gastroesophageal reflux instrument (visit 2, visit 5), the occurrence of adverse events, change in FVC, FEF25-75%, MIF50 / MEF50, peak expiratory flow rate, FEV1 reversibility, and the physical exam.
Additional measurements will include methacholine challenge and eosinophilia in induced sputum specimens. Induced sputum will be offered to all patients, though it is anticipated that only approximately 50% will agree to this procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be 18 years of age or older.
- Subjects baseline FEV1 must be greater than or equal to 50% of predicted at both Visit 1 and visit 2, when all bronchodilators medications have been withheld for the specified intervals.
- Subjects must have physician-diagnosed asthma at visit 1 and report ongoing chronic or intermittent symptoms that include at least one of the following: wheezing, chest tightness, dyspnea, or cough.
- All subjects with a baseline FEV1 greater than or equal to 70% predicted must have a positive methacholine challenge (provocative dose required to reduce FEV1 20% is less than or equal to 10 mg inhaled methacholine) at either visit 1 or visit 2.
Key exclusion criteria (10 listed)
- Female subjects who are pregnant or lactating.
- Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 21 days during the 6 months immediately prior to Visit 1.
- Subjects who require daily treatment with proton pump inhibitors, H2-receptor antagonists, or OTC anti-reflux medications).
- Subjects on immunotherapy, unless they are on a stable maintenance schedule for at least 6 months.
- Subjects who have used any investigational drug in the 30 days prior to visit 1.
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 |
|---|---|---|
| rabeprazole | Drug | – |
Primary outcome
Asthma symptoms
1 secondary outcome
Asthma quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Stephen A Tilles,, MD principal investigator
ASTHMA, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rabeprazole in people with Asthma and Gastroesophageal Reflux Disease, run by Associated Scientists to Help Minimize Allergies at 2 sites 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asthma symptoms. 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 23 Jun 2011.