Clincosm LogoSign in Get a demo

The Effect of Esomeprazole and Fundoplication on Airways

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00994708
Collaborator
(none)
1
Location

Study Details

Study Description

Brief 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.

Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial reactivity, exhaled NO, pulmonary function and quality of life.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
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
Study Start Date :
Dec 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Over 18 of age

    2. Diagnosis of gastroesophageal reflux disease

    3. Compliance to perform methacholine inhalation challenge (judged by the investigator)

    Exclusion Criteria:

    1. Known allergy to esomeprazole or any other PPI

    2. Use of systemic corticosteroids within 3 weeks before any study visit

    3. 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)

    4. Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit

    5. Regular use of PPI or H2-RA medication 3 months after fundoplication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampere University Hospital Tampere Finland 33521

    Sponsors and Collaborators

    • Tampere University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00994708
    Other Study ID Numbers:
    • R04002M
    First Posted:
    Oct 14, 2009
    Last Update Posted:
    Oct 14, 2009
    Last Verified:
    Oct 1, 2009
    Additional relevant MeSH terms:
    Esomeprazole

    Study Results

    No Results Posted as of Oct 14, 2009