NCT00317044CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 961
- Locations
- 1
- Primary Endpoint
- Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Esomeprazole 40 mg twice daily
Experimental
Intervention: Esomeprazole (Drug)
Esomeprazole 40 mg once daily
Experimental
Intervention: Esomeprazole (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).
Time Frame: Baseline to 6 months
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.
Secondary Outcomes
- Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))(Baseline to 6 months)
- Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total(Baseline to 6 months)
- Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months(Baseline to 6 months)
- Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma(Baseline to 6 months)
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.(From randomization (Visit 3) to visit 7.)
- Number of Patients With Severe Asthma Exacerbations.(Up to 6 months)
- Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7(From randomization (Visit 3) to Visit 7)
- Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7(Randomization (Visit 3) to Visit 7)
- Number of Severe Adverse Events(Up to 6 months)
- Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night(Baseline to 6 months)
- Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day(Baseline to 6 months)
- Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night(Baseline to 6 months)
Investigators
Study Sites (1)
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