Trial · NCT00317044
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
NCT00317044, Phase 2, Completed, AstraZeneca; results first posted 2014-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma. Trials, record NCT00317044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00317044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
- NCT number
- NCT00317044
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 961 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma, GERD
- Interventions
- Esomeprazole, Esomeprazole, Placebo
- First posted
- 2006-04-24
- Last updated
- 2014-06-09
- Results first posted
- 2014-06-09
- Limitations and caveats
- Numbers of patients analyzed in each of the Outcome Measures varies due to the amount of qualifying data captured for the patients.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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). | 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 | Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | 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. No dispersion measure available. |
| Secondary | Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Baseline to 6 months | Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores. |
| 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 | Baseline to 6 months | This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period. |
| Secondary | 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 percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. |
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period. | From randomization (Visit 3) to visit 7. | Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis. |
| Secondary | Number of Patients With Severe Asthma Exacerbations. | Up to 6 months | |
| Secondary | 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 | The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life). |
| Secondary | 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 | The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5. |
| Secondary | Number of Severe Adverse Events | Up to 6 months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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). | Baseline to 6 months | L/minute | LEAST_SQUARES_MEAN | |
| SECONDARY | Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | Baseline to 6 months | L/minute | LEAST_SQUARES_MEAN | |
| SECONDARY | Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Baseline to 6 months | Scores on a scale | LEAST_SQUARES_MEAN | |
| 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 | Baseline to 6 months | Inhalations | LEAST_SQUARES_MEAN | |
| SECONDARY | Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma | Baseline to 6 months | Percent of nights | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period. | From randomization (Visit 3) to visit 7. | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Patients With Severe Asthma Exacerbations. | Up to 6 months | Participants | NUMBER | |
| SECONDARY | 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 | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | 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 | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Severe Adverse Events | Up to 6 months | Events | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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). | Esomeprazole 40 mg Twice Daily | 21.1891 | Standard Error 2.8689 | L/minute | |
| 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). | Esomeprazole 40 mg Once Daily | 19.1847 | Standard Error 2.8422 | L/minute | |
| 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). | Placebo | 15.6771 | Standard Error 2.8086 | L/minute | |
| Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | Esomeprazole 40 mg Twice Daily | 21.88 | Standard Error 2.89 | L/minute | |
| Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | Esomeprazole 40 mg Once Daily | 18.37 | Standard Error 2.87 | L/minute | |
| Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute)) | Placebo | 18.55 | Standard Error 2.83 | L/minute | |
| Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Esomeprazole 40 mg Twice Daily | -0.61 | Standard Error 0.05721 | Scores on a scale | |
| Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Esomeprazole 40 mg Once Daily | -0.47 | Standard Error 0.05652 | Scores on a scale | |
| Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total | Placebo | -0.52 | Standard Error 0.05609 | Scores on a scale | |
| 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 | Esomeprazole 40 mg Twice Daily | -0.77 | Standard Error 0.10 | Inhalations |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esomeprazole 40 mg Twice Daily | 320 | |
| Overall Study | STARTED | Esomeprazole 40 mg Once Daily | 313 | |
| Overall Study | STARTED | Placebo | 328 | |
| Overall Study | COMPLETED | Esomeprazole 40 mg Twice Daily | 272 | |
| Overall Study | COMPLETED | Esomeprazole 40 mg Once Daily | 273 | |
| Overall Study | COMPLETED | Placebo | 283 | |
| Overall Study | NOT COMPLETED | Esomeprazole 40 mg Twice Daily | 48 | |
| Overall Study | NOT COMPLETED | Esomeprazole 40 mg Once Daily | 40 | |
| Overall Study | NOT COMPLETED | Placebo | 45 |
Source ClinicalTrials.gov
Adverse events57
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Esomeprazole 40 mg Twice Daily | 11 | 319 | |
| other | Bronchitis | Infections and infestations | Esomeprazole 40 mg Once Daily | 16 | 313 | |
| other | Bronchitis | Infections and infestations | Placebo | 18 | 328 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Esomeprazole 40 mg Twice Daily | 26 | 319 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Esomeprazole 40 mg Once Daily | 28 | 313 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 37 | 328 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Esomeprazole 40 mg Twice Daily | 0 | 319 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Esomeprazole 40 mg Once Daily | 0 | 313 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 328 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Esomeprazole 40 mg Twice Daily | 1 | 319 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esomeprazole 40 mg Twice Daily | ||
| Total, all-cause mortality | Esomeprazole 40 mg Once Daily | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Esomeprazole 40 mg Twice Daily | 37 | 319 |
| Total, other adverse events | Esomeprazole 40 mg Once Daily | 44 | 313 |
| Total, other adverse events | Placebo | 55 | 328 |
| Total, serious adverse events | Esomeprazole 40 mg Twice Daily | 7 | 319 |
| Total, serious adverse events | Esomeprazole 40 mg Once Daily | 5 | 313 |
| Total, serious adverse events | Placebo | 5 | 328 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20110554 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00317044
GET https://conductscience.org/api/trials/v1/NCT00317044/results?page=2