AsthmaNCT00200980
Importance of Non-Acid Reflux in Asthma in Children
An observational study of Asthma and Gastroesophageal Reflux, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The purpose of the study is to follow the medical course of children with moderate to severe asthma and see how this relates to whether they have acid of non-acid gastroesophageal reflux Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Asthma, Gastroesophageal Reflux
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to not given
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Moderate to Severe Asthma in Children 1 - 18 years
Who cannot join
- Antireflux surgery Unable to have 24 hr reflux study completed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Importance of Non-Acid Reflux in Moderate and Severe Asthma
The purpose of the study is to follow the medical course of children with moderate to severe asthma and see how this relates to whether they have acid of non-acid gastroesophageal reflux
Read the detailed description
Research Plan
Hypothesis and Specific Aims:
Asthma and gastroesophageal reflux are both common medical conditions in infants and children as in adults, and often co-exist (Gibson 2002, Andze, 1991). Though an association with overt reflux disease and asthma is well described and accepted, occult acid reflux has also been shown to be associated with asthma. The vexing question has been whether non-acidic reflux exacerbates asthma, particularly moderate to severe asthma. Current approaches and the extensive literature to date have dealt with the role of acid reflux only, and hence medical management is dominated by gastric acid suppression strategies recently outlined by a consensus statement from the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (Rudolph 2001). Based on this consensus, and randomized double blind studies in adults, our strategy is to now use long-term proton pump inhibitors. Clinically, this intervention has limited impact, and treatment failures are common. Now that non-acid gastroesophageal reflux can be measured with the combined impedance and pH probe, the role of non acid reflux can finally be evaluated. Our experience thus far confirms findings of limited published pediatric studies using a significant role for non-acid reflux in these "non -responders", and indeed suggests a greater role of non-acid GER in extra-esophageal disorders in general. This new tool supercedes the standard pH probe. Currently the standard of care for moderate to severe asthma is evaluation for association with gastroesophageal reflux. These cases at NCC-Wilmington undergo 24 hour combined impedance and pH study. With the advent of this new tool at NCC-Orlando also, we plan to combine resources at several sites to accumulate data on prevalence of acid and non-acid reflux in asthma. This would be an effective use of data retrieval attributes of EPIC. Future studies looking at the impact of type of refluxate on bronchospasm, parenchymal damage, and even chronic pulmonary vascularity changes prospectively would then be set up. Since currently we have no specific recommendations for medical treatment of non-acid GER, therapeutic strategies, either with existing or newer motility agents, could also be evaluated in the future to develop practice guidelines.
Specific Aim:. What is the prevalence of acid and non-acid GER in moderate to severe asthma patients referred for GI evaluation
Prevalence of acid and non-acid gastroesophageal reflux in children 1 to 18 yrs with moderate asthma and severe asthma, referred for evaluation of gastroesophageal reflux at NCC-Wilmington, New Jersey, and NCC-Orlando will be obtained. This information will be extracted from EPIC templates that have current standards of care incorporated.
- Conditions
- Asthma, Gastroesophageal Reflux
- Medical subject headings
- Asthma, Gastroesophageal Reflux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 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
- Observational
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Investigators
- Devendra I Mehta, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200980
- Sponsor's protocol ID
- 0504609
- Status last verified
- Mar 2009
- First submitted
- 12 Sep 2005
- Last updated
- 9 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Non-Acid Reflux in Moderate and Severe Asthma
- ClinicalTrials.gov ID
- NCT00200980
- Acronym / sponsor ID
- 0504609
- Conditions
- Asthma, Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Study start
- Aug 2005
- First posted
- 20 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 purpose of the study is to follow the medical course of children with moderate to severe asthma and see how this relates to whether they have acid of non-acid gastroesophageal reflux
Detailed description
Research Plan
Hypothesis and Specific Aims:
Asthma and gastroesophageal reflux are both common medical conditions in infants and children as in adults, and often co-exist (Gibson 2002, Andze, 1991). Though an association with overt reflux disease and asthma is well described and accepted, occult acid reflux has also been shown to be associated with asthma. The vexing question has been whether non-acidic reflux exacerbates asthma, particularly moderate to severe asthma. Current approaches and the extensive literature to date have dealt with the role of acid reflux only, and hence medical management is dominated by gastric acid suppression strategies recently outlined by a consensus statement from the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (Rudolph 2001). Based on this consensus, and randomized double blind studies in adults, our strategy is to now use long-term proton pump inhibitors. Clinically, this intervention has limited impact, and treatment failures are common. Now that non-acid gastroesophageal reflux can be measured with the combined impedance and pH probe, the role of non acid reflux can finally be evaluated. Our experience thus far confirms findings of limited published pediatric studies using a significant role for non-acid reflux in these "non -responders", and indeed suggests a greater role of non-acid GER in extra-esophageal disorders in general. This new tool supercedes the standard pH probe. Currently the standard of care for moderate to severe asthma is evaluation for association with gastroesophageal reflux. These cases at NCC-Wilmington undergo 24 hour combined impedance and pH study. With the advent of this new tool at NCC-Orlando also, we plan to combine resources at several sites to accumulate data on prevalence of acid and non-acid reflux in asthma. This would be an effective use of data retrieval attributes of EPIC. Future studies looking at the impact of type of refluxate on bronchospasm, parenchymal damage, and even chronic pulmonary vascularity changes prospectively would then be set up. Since currently we have no specific recommendations for medical treatment of non-acid GER, therapeutic strategies, either with existing or newer motility agents, could also be evaluated in the future to develop practice guidelines.
Specific Aim:. What is the prevalence of acid and non-acid GER in moderate to severe asthma patients referred for GI evaluation
Prevalence of acid and non-acid gastroesophageal reflux in children 1 to 18 yrs with moderate asthma and severe asthma, referred for evaluation of gastroesophageal reflux at NCC-Wilmington, New Jersey, and NCC-Orlando will be obtained. This information will be extracted from EPIC templates that have current standards of care incorporated.
Study design
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Moderate to Severe Asthma in Children 1 - 18 years
Key exclusion criteria (1 listed)
- Antireflux surgery Unable to have 24 hr reflux study completed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 9 Mar 2009.
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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.
Devendra I Mehta principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Gastroesophageal Reflux, run by Nemours Children's Clinic 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 1 inclusion and 1 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 9 Mar 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 9 Mar 2009.