Adult Asthmatics and Acid Reflux

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg twice a day

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

40mg twice a day

Interventions

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Esomeprazole

40mg twice a day

Intervention Type DRUG

Placebo

40mg twice a day

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No