The Effect of Esomeprazole and Fundoplication on Airways

Airway Responsiveness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994708
• Other study ID #: R04002M
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2009
• Last updated: October 13, 2009
• Start date: December 2004

Study information

• Verified date: October 2009
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Airway Responsiveness
• Gastroesophageal Reflux

Intervention

Drug:
• esomeprazole

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland,