Adult Asthmatics and Acid Reflux

The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.

Completed

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of asthma
Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
Severe heartburn 3 days/week during the run-in period.

Exclusion criteria

Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1.
Any other significant disease or pathology judged to be clinically significant by the investigator

Treatment and study plan

Esomeprazole

Drug

40mg twice a day

Other names: Nexium

Placebo

Drug

40mg twice a day

Primary outcomes

Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores

Time frame: 4 weekly

Secondary outcomes

Safety as assessed by adverse event recording and clinical and laboratory measurements.

Time frame: 4 weekly

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Mar 5, 2008
Registry last updated: Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed