AsthmaPhase 4NCT00237068
A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.
A Phase 4 study testing Lansoprazole; Solutab in people with Asthma, run by Emory University at 3 sites in United States.
Trial summary
Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have demonstrated that asthma and GERD often co-exists, and that this co-existence is more frequent than just chance. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Lansoprazole; Solutab
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Dec 2010
- Phase
- Phase 4
- 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 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-11 years Informed Consent/ Assent Asthma Clinically normal laboratory results and physical exam
Who cannot join
- Unable or unwilling to give informed consent Unable to comply with study protocol Any preexisting condition that would require A PPI for a period of 6 months or more and/other major chronic illnesses.
- Drug Allergies toPPI. At High risk for non-compliance and/or adherence.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Children's Center
Atlanta, Georgia, 30322
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342
Georgia Pediatric Pulmonology Associates/ CHOA
Atlanta, Georgia, 30342
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma
Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have demonstrated that asthma and GERD often co-exists, and that this co-existence is more frequent than just chance. Therefore, studies that characterize associations between these conditions, and, help in the development of interventions will positively impact the outcomes of these patients, which are critically needed.
Subjects that participate in this study are required to be between the ages of 4-11 years old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use, or frequent asthma episodes.
Read more
The purpose of this research study is to:
- Determine, whether children with symptomatic, poorly controlled, asthma assigned to treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than similar participants assigned to placebo for a similar duration of time
- Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor): have a longer time to first exacerbation, have improved lung function, improved asthma symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma medications, reduced emergency room/urgent care/ physician office visits that are asthma related.
- Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from PPI's, can be identified.
Read the detailed description
GERD and asthma likely co-exist, and may be pathogenetically linked. However, it is controversial whether GERD per se is an important risk factor for severe asthma, and whether treatment of GERD and/or GERD symptoms improves asthma control. In addition, there are no published data on how often asthmatics are treated with the anti-secretory agents proton pump inhibitors (PPIs) for GERD. However, a preliminary survey from the American Lung Association's Asthma Clinical Research Centers consortium show diverse practice patterns among clinics with about 15% of children and 20% - 30% of adults being prescribed medical treatment (unpublished data).
The NIH Expert Panel on The Diagnosis and Management of Asthma, recommends that "…for patients with poorly controlled asthma, particularly with a nocturnal component, investigation for gastroesophageal reflux may be warranted even in the absence of suggestive symptoms". The American Thoracic Society (ATS) workshop on severe refractory asthma, concluded that GERD "…could contribute to the severity" of asthma and recommended that all patients with severe refractory asthma undergo esophageal pH probe monitoring to evaluate for the presence of GERD". Noticeably absent in both of these "expert panel" documents were randomized placebo controlled trial data in all populations, and properly designed clinical trial information in the pediatric population with clear case and control definitions of GERD and asthma. The American Gastroenterological Association recommends ambulatory pH probe monitoring in adult patients with reflux-triggered asthma; but, to date has developed no recommendations for children 20. While these are reasonable recommendations, there is no convincing evidence that GERD is more common in patients with severe asthma than mild asthma, or that treatment of reflux can decrease asthma severity. PPIs, the most effective treatment for GERD (i.e., resolve both symptoms and mucosal disease), have a retail cost between $100 and $153 per month. However, recent hospital data demonstrates that anti-reflux surgery is being performed at an increasing rate in children with respiratory manifestations of their GERD at a sizeable cost and with no long term outcome studies to date. Thus, it can be estimated that the cost for diagnosing and treating GERD in symptomatic asthmatics ranges from $1 to $8 billion dollars per year if all poorly controlled asthmatics were both investigated and treated. Therefore, randomized controlled clinical trials are critically needed to reduce overall healthcare costs and the public health burden of these two chronic conditions.
- Conditions
- Asthma
- Being tested
- Lansoprazole; Solutab
- Keywords
- Gastroesophageal Reflux
- 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.
Lansoprazole; SolutabDrug
Also called Prevacid
15 and 30 mg doses of dissolvable tablet, 2 tablets daily for one year
What is being measured
The primary outcome is the main question the study is designed to answer.
One of the aims of this trial is to see if we can demonstrate a significant response to acid-suppression therapy in a group of poorly controlled childhood asthmatics using the number of asthma exacerbations as outcome variables.
Measured: 3 year
Secondary outcomes (1)
A major unanswered question is whether severity or frequency of asthma is related to the response to anti-reflux treatment.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMar 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
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.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Investigators
- Benjamin D. Gold, MD., Principal investigator, Emory University School of Medicine / Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237068
- Sponsor's protocol ID
- GERD AsthmaStudy
- Status last verified
- Mar 2011
- First submitted
- 11 Oct 2005
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma
- ClinicalTrials.gov ID
- NCT00237068
- Acronym / sponsor ID
- GERD AsthmaStudy
- Conditions
- Asthma
- Keywords
- Gastroesophageal Reflux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 12 Oct 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.
Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have demonstrated that asthma and GERD often co-exists, and that this co-existence is more frequent than just chance. Therefore, studies that characterize associations between these conditions, and, help in the development of interventions will positively impact the outcomes of these patients, which are critically needed.
Subjects that participate in this study are required to be between the ages of 4-11 years old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use, or frequent asthma episodes.
The purpose of this research study is to:
- Determine, whether children with symptomatic, poorly controlled, asthma assigned to treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than similar participants assigned to placebo for a similar duration of time
- Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor): have a longer time to first exacerbation, have improved lung function, improved asthma symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma medications, reduced emergency room/urgent care/ physician office visits that are asthma related.
- Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from PPI's, can be identified.
Detailed description
GERD and asthma likely co-exist, and may be pathogenetically linked. However, it is controversial whether GERD per se is an important risk factor for severe asthma, and whether treatment of GERD and/or GERD symptoms improves asthma control. In addition, there are no published data on how often asthmatics are treated with the anti-secretory agents proton pump inhibitors (PPIs) for GERD. However, a preliminary survey from the American Lung Association's Asthma Clinical Research Centers consortium show diverse practice patterns among clinics with about 15% of children and 20% - 30% of adults being prescribed medical treatment (unpublished data).
The NIH Expert Panel on The Diagnosis and Management of Asthma, recommends that "…for patients with poorly controlled asthma, particularly with a nocturnal component, investigation for gastroesophageal reflux may be warranted even in the absence of suggestive symptoms". The American Thoracic Society (ATS) workshop on severe refractory asthma, concluded that GERD "…could contribute to the severity" of asthma and recommended that all patients with severe refractory asthma undergo esophageal pH probe monitoring to evaluate for the presence of GERD". Noticeably absent in both of these "expert panel" documents were randomized placebo controlled trial data in all populations, and properly designed clinical trial information in the pediatric population with clear case and control definitions of GERD and asthma. The American Gastroenterological Association recommends ambulatory pH probe monitoring in adult patients with reflux-triggered asthma; but, to date has developed no recommendations for children 20. While these are reasonable recommendations, there is no convincing evidence that GERD is more common in patients with severe asthma than mild asthma, or that treatment of reflux can decrease asthma severity. PPIs, the most effective treatment for GERD (i.e., resolve both symptoms and mucosal disease), have a retail cost between $100 and $153 per month. However, recent hospital data demonstrates that anti-reflux surgery is being performed at an increasing rate in children with respiratory manifestations of their GERD at a sizeable cost and with no long term outcome studies to date. Thus, it can be estimated that the cost for diagnosing and treating GERD in symptomatic asthmatics ranges from $1 to $8 billion dollars per year if all poorly controlled asthmatics were both investigated and treated. Therefore, randomized controlled clinical trials are critically needed to reduce overall healthcare costs and the public health burden of these two chronic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4-11 years Informed Consent/ Assent Asthma Clinically normal laboratory results and physical exam
Key exclusion criteria (2 listed)
- Unable or unwilling to give informed consent Unable to comply with study protocol Any preexisting condition that would require A PPI for a period of 6 months or more and/other major chronic illnesses.
- Drug Allergies toPPI. At High risk for non-compliance and/or adherence.
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 |
|---|---|---|
| Lansoprazole; SolutabAlso: Prevacid15 and 30 mg doses of dissolvable tablet, 2 tablets daily for one year | Drug | – |
Primary outcome
One of the aims of this trial is to see if we can demonstrate a significant response to acid-suppression therapy in a group of poorly controlled childhood asthmatics using the number of asthma exacerbations as outcome variables.
Time frame: 3 year
1 secondary outcome
A major unanswered question is whether severity or frequency of asthma is related to the response to anti-reflux treatment.
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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.
Benjamin D. Gold, MD. principal investigator
Emory University School of Medicine / Pediatrics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole; Solutab in people with Asthma, run by Emory University at 3 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
One of the aims of this trial is to see if we can demonstrate a significant response to acid-suppression therapy in a group of poorly controlled childhood asthmatics using the number of asthma exacerbations as outcome variables. (time frame: 3 year). 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 16 Mar 2011; AzTrials last refreshed its copy on 6 Nov 2026.