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The Effect of Esomeprazole and Fundoplication on Airways

This study has been completed.
Sponsor:
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT00994708
First received: October 12, 2009
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Airway Responsiveness
 Drug: esomeprazole
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Study Start Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994708

Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00994708     History of Changes
Other Study ID Numbers: R04002M
Study First Received: October 12, 2009
Last Updated: October 13, 2009
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013