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CompletedNCT00994708Updated Oct 14, 2009

The Effect of Esomeprazole and Fundoplication on Airways

A Phase 3 interventional study of esomeprazole in Airway Responsiveness, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-14.

Sponsored by Tampere University Hospital · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Airway Responsiveness
03

In context

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3

Interventions

  • Drugesomeprazole
06

Study locations

1 site
  • Tampere University Hospital
    Tampere, 33521, Finland
07

References and documents

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 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00994708
Lead sponsor
Tampere University Hospital
First posted
Oct 14, 2009
Start date
Dec 2004
Last update
Oct 14, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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