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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00317044

Purpose

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.

Condition	Intervention	Phase
Asthma GERD	Drug: Esomeprazole	Phase II

MedlinePlus related topics: Asthma GERD

Drug Information available for: Magnesium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	1100
Study Start Date:	April 2006
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317044

Show 134 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Nexium Medical Science Director, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D9618C00001, RELAX
Study First Received:	April 20, 2006
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00317044
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Moderate to severe Asthma
Gastroesophageal Reflux Disease
esomeprazole
GERD

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Omeprazole
Asthma
Gastroesophageal Reflux
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009