The Effect of Esomeprazole and Fundoplication on Airways

NCT00994708 | Completed Phase 3

• 1 other identifier: R04002M
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Responsiveness

Interventions

esomeprazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Related Publications (1)

• 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.

  PMID: 23006321 DERIVED

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: December 1, 2004
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

FI (1)