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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Tampere University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014