At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 961 enrolled
Drug / intervention
Esomeprazole +2 moredrug
Likely dose
Esomeprazole 40 mg twice daily or 40 mg once dailyAI-extracted
Key inclusion· 4
- ✓Age 18 and over (adults)
- ✓Asthma diagnosis for at least 6 months
- ✓Active asthma symptoms during run-in period
- ✓At least 3 months history of GERD symptoms: burning behind breastbone, pain behind breastbone, or acid taste in mouth
Key exclusion· 3
- ✕Clinically relevant abnormalities (unspecified)
- ✕Smoking history of 10 pack-years or more
- ✕Prior surgery on esophagus or stomach
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma
In Brief
A Phase 2 clinical trial evaluating Esomeprazole and Placebo for Asthma and GERD. Completed, enrolled 961 participants across 130 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedApr 2006
Primary CompletionJul 2008
TodayJul 2026
First PostedApr 24, 2006
Enrollment StartApr 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.2 years ago
Interventions
Esomeprazoledrug
Esomeprazole 40 mg twice daily
Esomeprazoledrug
Esomeprazole 40 mg once daily
Placebodrug
Placebo twice daily