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OpenTrials
Completed

NCT Number: NCT00994708

The Effect of Esomeprazole and Fundoplication on Airways

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.

Completed

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Key information

Conditions

Airway Responsiveness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 of age
  • Diagnosis of gastroesophageal reflux disease
  • Compliance to perform methacholine inhalation challenge (judged by the investigator)

Exclusion criteria

  • Known allergy to esomeprazole or any other PPI
  • Use of systemic corticosteroids within 3 weeks before any study visit
  • 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)
  • Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit
  • Regular use of PPI or H2-RA medication 3 months after fundoplication

Treatment and study plan

Esomeprazole

Drug

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2004
First posted
Oct 14, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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