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

Condition(s) targeted: Asthma; GERD

Intervention: Esomeprazole (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Primary objective is to compare the anti-asthmatic effect of esomeprazole with that of placebo in adult asthmatics with gastroesophageal reflux by evaluating change in morning Peak Expiratory Flow from baseline (run-in) to treatment period.

Secondary outcome: Secondary objectives are to investigate the effect on symptoms of GERD as measured by Reflux Disease Questionnaire from randomization to end of study and to assess safety and tolerability by AEs, laboratory tests, physical examination, and vital signs.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults with diagnosis of asthma since at least 6 months.

- Symptoms of asthma during run-in.

- At least 3 months history and present symptoms of 1 or more of the following: burning

feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Exclusion Criteria:

- Patients with clinically relevant abnormalities.

- Patients with a smoking history of ≥10 pack-year.

- Patients who have had previous surgery on the esophagus or the stomach.

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AstraZeneca Clinical Trial Information - Outside US

Starting date: April 2006
Ending date: May 2008
Last updated: May 22, 2008