Airway ResponsivenessPhase 3NCT00994708
The Effect of Esomeprazole and Fundoplication on Airways
A Phase 3 study testing esomeprazole in people with Airway Responsiveness, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Evaluate the prevalence of bronchial responsiveness (BHR) among patients with gastroesophageal reflux disease (GERD). Investigate correlation between bronchial reactivity and the severity of GERD, and similarly investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Responsiveness
- What is being tested?
- esomeprazole
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Dec 2004to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 of age
- Diagnosis of gastroesophageal reflux disease
- Compliance to perform methacholine inhalation challenge (judged by the investigator)
Who cannot join
- Known allergy to esomeprazole or any other PPI
- Use of systemic corticosteroids within 3 weeks before any study visit
- Pregnancy (in a written informed consent patients are asked to assure that they are not pregnant and they are also told to immediately stop the study medication if they become pregnant during the study)
- Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit
- Regular use of PPI or H2-RA medication 3 months after fundoplication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Esomeprazole and Nissen Fundoplication on Bronchial Responsiveness, Quality of Life, Exhaled Nitric Oxide and Pulmonary Function in Patients With Gastroesophageal Reflux Disease
Evaluate the prevalence of bronchial responsiveness (BHR) among patients with gastroesophageal reflux disease (GERD).
Investigate correlation between bronchial reactivity and the severity of GERD, and similarly investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD.
Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial reactivity, exhaled NO, pulmonary function and quality of life.
- Conditions
- Airway Responsiveness
- Being tested
- esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ResponsivenessStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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 3
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994708
- Sponsor's protocol ID
- R04002M
- Status last verified
- Oct 2009
- First submitted
- 12 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
Publications
Kiljander T, Rantanen T, Kellokumpu I, Koobi T, Lammi L, Nieminen M, Poussa T, Ranta A, Saarelainen S, Salminen P. Comparison of the effects of esomeprazole and fundoplication on airway responsiveness in patients with gastro-oesophageal reflux disease. Clin Respir J. 2013 Jul;7(3):281-7. doi: 10.1111/crj.12005. Epub 2012 Oct 24.
PubMed 23006321
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esomeprazole and Nissen Fundoplication on Bronchial Responsiveness, Quality of Life, Exhaled Nitric Oxide and Pulmonary Function in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00994708
- Acronym / sponsor ID
- R04002M
- Conditions
- Airway Responsiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Dec 2004
- First posted
- 14 Oct 2009 (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.
Evaluate the prevalence of bronchial responsiveness (BHR) among patients with gastroesophageal reflux disease (GERD).
Investigate correlation between bronchial reactivity and the severity of GERD, and similarly investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD.
Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial reactivity, exhaled NO, pulmonary function and quality of life.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 of age
- Diagnosis of gastroesophageal reflux disease
- Compliance to perform methacholine inhalation challenge (judged by the investigator)
Key exclusion criteria (5 listed)
- Known allergy to esomeprazole or any other PPI
- Use of systemic corticosteroids within 3 weeks before any study visit
- Pregnancy (in a written informed consent patients are asked to assure that they are not pregnant and they are also told to immediately stop the study medication if they become pregnant during the study)
- Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit
- Regular use of PPI or H2-RA medication 3 months after fundoplication
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 |
|---|---|---|
| esomeprazole | Drug | – |
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 14 Oct 2009.
- Derived from this study: PubMed 23006321Kiljander T, Rantanen T, Kellokumpu I, Koobi T, Lammi L, Nieminen M, Poussa T, Ranta A, Saarelainen S, Salminen P. Comparison of the effects of esomeprazole and fundoplication on airway responsiveness in patients with gastro-oesophageal reflux disease. Clin Respir J. 2013 Jul;7(3):281-7. doi: 10.1111/crj.12005. Epub 2012 Oct 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing esomeprazole in people with Airway Responsiveness, run by Tampere University Hospital at 1 site in Finland.
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 3 inclusion and 5 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 14 Oct 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 Finland. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994708, which also lists 1 linked publication.
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 14 Oct 2009.