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NCT00317044 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Asthma and GERD, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
961
Enrollment target
20
Study locations

NCT00317044: Completed Phase 2 study of Asthma and GERD, sponsored by AstraZeneca.

NCT00317044 is a Phase 2 study of Asthma and GERD that has completed, run by AstraZeneca. The registered enrollment target is 961 participants, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00317044, a Phase 2 study of Asthma and GERD, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
961 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Esomeprazole

Study Locations (20)

Georgia

  • Research Site - Atlanta
  • Research Site - Stockbridge

Kansas

  • Research Site - Overland Park
  • Research Site - Wichita

Ohio

  • Research Site - Cincinnati
  • Research Site - Sylvania

Pennsylvania

  • Research Site - Pittsburgh
  • Research Site - Upland

Alabama

  • Research Site - Birmingham

Arizona

  • Research Site - Scottsdale

Arkansas

  • Research Site - Little Rock

California

  • Research Site - Fountain Valley

Trial Details

FieldValue
Enrollment Target 961 participants
Start Date 2006-04
Est. Completion 2008-07
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT00317044 record still lists

NCT00317044 is an interventional study that assigns participants to a tested intervention. The registered 961 participants enrollment target is mid-sized for trials with a published cap, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (38% lower).

The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00317044 names 20 study sites across 16 states, led by Georgia, Kansas, Ohio.

Frequently Asked Questions

What is clinical trial NCT00317044 about?

NCT00317044 is a clinical study titled "Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma". 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.

What is the current status of trial NCT00317044?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 961 participants. The study started on 2006-04. Estimated completion is 2008-07.

What conditions does trial NCT00317044 study?

This clinical trial studies the following conditions: Asthma, GERD.

What interventions are being tested in trial NCT00317044?

The interventions under investigation include: Placebo (DRUG), Esomeprazole (DRUG).

Who is sponsoring clinical trial NCT00317044?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00317044 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00317044's enrollment target sits among peer trials

961 46th of 374 higher than 329 of 374 other Asthma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00317044, the US trial registry maintained by the National Library of Medicine. NCT00317044 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.