Phase 2
Completed N=961
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
Asthma · GERD
Source: ClinicalTrials.gov NCT00317044 ↗
Enrolled (actual)
961
Serious AEs
1.8%
Results posted
Jun 2014
Primary outcomePrimary: 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). — 21.1891; 19.1847; 15.6771 L/minute
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
21.1891; 19.1847; 15.6771 | — |
| SECONDARY Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) |
21.88; 18.37; 18.55 | — |
| SECONDARY Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total |
-0.61; -0.47; -0.52 | — |
| SECONDARY 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 |
-0.77; -0.73; -0.68 | — |
| SECONDARY Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma |
-0.238; -0.219; -0.223 | — |
| SECONDARY Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period. |
0.09; 0.07; 0.02 | — |
| SECONDARY Number of Patients With Severe Asthma Exacerbations. |
33; 41; 43 | — |
| SECONDARY Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7 |
0.97; 0.83; 0.55 | — |
| SECONDARY Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7 |
-1.95; -1.91; -1.27 | — |
| SECONDARY Number of Severe Adverse Events |
4; 5; 9 | — |
| SECONDARY Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night |
-0.31; -0.23; -0.27 | — |
| SECONDARY Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day |
-0.30; -0.25; -0.25 | — |
| SECONDARY Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night |
-0.30; -0.27; -0.29 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00317044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.