The Effect of Esomeprazole and Fundoplication on Airways

Tampere University Hospital

Status and phase: Completed; Phase 3

Conditions: Airway Responsiveness

Treatments: Drug: esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00994708

R04002M

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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