CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 403 enrolled
Drug / intervention
Esomeprazole +1 moredrug
Likely dose
Esomeprazole 40 mg orally twice dailyAI-extracted
Key inclusion· 8
  • ✓Age 18 years or older
  • ✓Physician-diagnosed asthma
  • ✓If FEV1 ≥70% predicted: demonstrate methacholine PC20 <16 mg/ml during Visit 1
  • ✓If FEV1 50-70% predicted: demonstrate ≥12% reversibility during Visit 1 or within past 12 months
Key exclusion· 7
  • ✕FEV1 <50% predicted normal pre-bronchodilator
  • ✕Severe GERD symptoms: ≥2 heartburn episodes per week requiring antacids or clinical indication for PPI/H2 blocker
  • ✕Prior anti-reflux or peptic ulcer surgery
  • ✕Major chronic illnesses: non-skin cancer, endocrine disease, coronary artery disease, congestive heart failure, stroke, severe hypertension, Type 1 diabetes, renal failure, liver disorders, immunodeficiency, major neuropsychiatric disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00069823
NCT00069823Phase 3Completed
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The Study of Acid Reflux in Asthma

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Oct 3, 2003·Updated Dec 19, 2012

In Brief

A Phase 3 clinical trial evaluating Esomeprazole and Placebo proton pump inhibitor for Asthma and 2 related conditions. Completed, enrolled 403 participants across 20 sites.

Detailed Summary

The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Lung Diseases, Lung Diseases, Obstructive
CountriesUnited States
CollaboratorsAmerican Lung Association Asthma Clinical Research Centers, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 3, 2003
Enrollment StartSep 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 22.7 years ago

Interventions

Esomeprazoledrug

Proton pump inhibitor 40 mg orally twice daily

Placebo proton pump inhibitordrug

Placebo proton pump inhibitor