Adult Asthmatics and Acid Reflux

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628953

SD-NEE-0003

D9611C00003

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,400 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Esomeprazole

2

Placebo Comparator group

Treatment:

Drug: Placebo