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

October 12, 2009
October 13, 2009
December 2004
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Complete list of historical versions of study NCT00994708 on ClinicalTrials.gov Archive Site
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The Effect of Esomeprazole and Fundoplication on Airways
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.

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Interventional
Phase 3
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Airway Responsiveness
Drug: esomeprazole
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Kiljander T, Rantanen T, Kellokumpu I, Kööbi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00994708
R04002M
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Tampere University Hospital
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Tampere University Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP