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Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma

NCT00317044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 961

Last updated 2014-06-09

Study results available
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Summary

The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

Conditions

Interventions

DRUG

Esomeprazole

Esomeprazole 40 mg twice daily

DRUG

Esomeprazole

Esomeprazole 40 mg once daily

DRUG

Placebo

Placebo twice daily

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Nexium Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Slovakia
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317044 on ClinicalTrials.gov