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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma GERD

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

U.S. FDA Resources

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:	April 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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. Epub 2010 Jan 28.

ClinicalTrials.gov Identifier:	NCT00317044 History of Changes
Other Study ID Numbers:	D9618C00001, RELAX
Study First Received:	April 20, 2006
Last Updated:	March 11, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Moderate to severe Asthma
Gastroesophageal Reflux Disease
esomeprazole
GERD

Additional relevant MeSH terms:

Asthma
Gastroesophageal Reflux
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Anti-Asthmatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012