Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma (RELAX)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma; GERD

Treatments: Drug: Placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317044

D9618C00001

RELAX

Details and patient eligibility

About

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.

Enrollment: 961 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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961 participants in 3 patient groups, including a placebo group

Esomeprazole 40 mg twice daily

Experimental group

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

Esomeprazole 40 mg once daily

Experimental group

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo