AsthmaPhase 3NCT00069823
Study of Acid Reflux in Asthma
A Phase 3 study testing Esomeprazole in people with Asthma and Lung Diseases, run by Johns Hopkins Bloomberg School of Public Health at 20 sites in United States.
Trial summary
The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Lung Diseases, Lung Diseases, Obstructive
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 403 participants
- Where
- 20 sitesUnited States
- Study dates
- Sep 2003to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The general goal of patient selection is to enroll patients for whom asthma physicians might prescribe GERD treatment, but where there is uncertainty whether it might be effective.
- Age 18 or older
- Physician diagnosed asthma
- If amount of air expired in the first second during a forced expiratory maneuver (FEV1) is greater than or equal to 70% predicted normal pre-bronchodilator: demonstrate methacholine 20% from post-diluent baseline (PC20). PC20 less than 16 mg/ml during Visit 1
- If FEV1 less than 70% and greater than or equal to 50% predicted normal pre-bronchodilator: demonstrate 12% reversibility during Visit 1 or within past 12 months
- Currently on stable dose of daily inhaled steroids for asthma control, i.e., inhaled corticosteroid equivalent to 400 ug/day of fluticasone44 or greater for 8 weeks or longer
Show all 9Show fewer
- Poor asthma control: Either of the following; a score of 1.5 or greater on the Juniper Asthma Control Questionnaire; two or more episodes of asthma symptoms in the past 12 months with each episode requiring at least one of the following: an emergency department visit, unscheduled physician visit, prednisone course, hospitalization
- Non-smoker for 6 months or longer
- Less than 10 pack/year smoking history
Who cannot join
- Surgery: Previous anti-reflux or peptic ulcer surgery
- Pulmonary function: FEV1 less than 50% predicted normal pre-bronchodilator
- GERD Symptoms: Severe reflux constituting a clinical indication for treatment with a PPI or H2 blocker, typically two or more episodes per week of heartburn requiring antacids
- Other major chronic illnesses; conditions which in the judgment of the Study Physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, congestive heart failure, stroke, severe hypertension, Type 1 insulin dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, major neuropsychiatric disorder
- Medication use: Anti-reflux medication (proton pump inhibitors or H2 blockers) within 1 month Theophylline, azoles, iron, anti-coagulants, insulin (for Type I diabetes), digitalis, any investigative drugs within 1 month
- Drug allergy: Previous adverse effects from proton pump inhibitors or methacholine challenge
Show all 12Show fewer
- Females of childbearing potential: Pregnant or lactating, unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal)
- Inability or unwillingness to provide consent
- Inability to perform baseline measurements
- Completion of less than 10 of the last 14 days of screening period diary entry
- Inability to be contacted by telephone
- Intention to move out of the area within 6 months
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northern New England Consortium
Colchester, Vermont, 05446
Ohio State University
Columbus, Ohio, 43210
National Jewish Medical and Research Center
Denver, Colorado, 80206
Duke University
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030-3411
Indiana University ACRC
Indianapolis, Indiana, 46202
Nemours Childrens Clinic
Jacksonville, Florida, 32207
Univ of MO Kansas City School of Medicine
Kansas City, Missouri, 64108
University of Miami
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
North Shore-LIJ Medical Center
New Hyde Park, New York, 11040
LSUHSC Pulmonary Critical Care
New Orleans, Louisiana, 70112
NYU School of Medicine
New York, New York, 10016
Thomas Jefferson Hospital Pulmonary Lab
Philadelphia, Pennsylvania, 19107
University of California, San Diego
San Diego, California, 92103
Washington University School of Medicine
St Louis, Missouri, 63310-1093
New York Medical College
Valhalla, New York, 10595
About this study
Official title: The Study of Acid Reflux in Asthma
The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
Read the detailed description
BACKGROUND:
Gastroesophageal reflux (GERD) is frequent in asthmatics with poor asthma control, often occurs without symptoms, and can induce bronchoconstriction. Poorly controlled asthmatics are often treated for GERD with drugs that suppress gastric acid, but this treatment is expensive and the benefit of such treatment is not established. Proton pump inhibitors are a relatively new class of medications that provide highly effective treatment for GERD and associated problems. This success has led many doctors to begin PPI treatment in their asthma patients in an attempt to achieve better asthma control.
DESIGN NARRATIVE:
The randomized, placebo-controlled trial will enroll 400 asthmatics, ages 18 or older, who have poor asthma control on inhaled steroids, defined on the basis of excessive bronchodilator use, nocturnal awakenings, or frequent exacerbations. Participants will be randomly assigned to treatment with either a proton pump inhibitor, esomeprazole (Nexium) 40 mg twice a day, or matching placebo. The presence, severity, and temporal relationship of GERD to asthma symptoms will be documented with 24 hour ambulatory esophageal potential Hydrogen (pH) probe monitoring, but participants will be enrolled irrespective of the severity of GERD. The primary outcome measure is the proportion of participants who have exacerbations of asthma within a 6-month period defined by asthma diaries and interviews. Secondary outcome measures include asthma symptom and control scores, asthma-specific and generic health-related quality of life, GERD symptoms, health care use, pulmonary function, and airways reactivity. Pre-specified subgroup analyses will be conducted to determine if there are clinical or demographic characteristics that predict benefit from treatment of GERD in asthma.
- Conditions
- Asthma, Lung Diseases, Lung Diseases, Obstructive
- Being tested
- Esomeprazole, Placebo proton pump inhibitor
- Medical subject headings
- Asthma, Lung Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
Proton pump inhibitor 40 mg orally twice daily
Placebo proton pump inhibitorDrug
Placebo proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole | Experimental | Proton pump inhibitor of gastric acid Receives: Drug: Esomeprazole |
| Placebo for esomeprazoe | Placebo comparator | Placebo Receives: Drug: Placebo proton pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion
Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma
Measured: Baseline to 24 Weeks
Secondary outcomes (17)
Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days
Measured: Baseline to 24 Weeks
Exacerbation Components: Urgent Care Visit
Measured: Measured at Month 6
Exacerbation Components: New Use of Oral Corticosteroids
Measured: Baseline to 24 Weeks
Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists
Measured: Baseline to 24 Weeks
Use of Rescue Medications
Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.
Measured: Baseline to 24 Weeks
Night Awakening
Rate of awakening at night because of asthma symptoms
Measured: Baseline to 24 Weeks
Pulmonary Function: Change in Prebronchodilator FEV1
Mean change in pre-bronchodilator FEV1 - forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups.
Measured: Baseline to 24 Weeks
Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity
Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks
Measured: Baseline to 24 Weeks
Pulmonary Function: Change in Peak Flow Rate
Mean change from baseline to 24 weeks in the peak flow rate - how forceful patient can blow out air
Measured: Baseline to 24 Weeks
Pulmonary Function: Change in PC20
Mean Change in the dose of methacholine that results in a 20% drop in FEV1
Measured: Baseline to 24 Weeks
Change in Juniper Asthma Control Score(JACQ)
Mean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference.
Measured: Baseline to 24 Weeks
Change in Asthma Symptom Utility Index (ASUI)
Mean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma.
Measured: Baseline to 24 Weeks
Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Mean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.
Measured: Baseline to 24 Weeks
Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component
Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.
Measured: Baseline to 24 Weeks
Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component
Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.
Measured: Baseline to 24 Weeks
Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score
Mean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress.
Measured: Baseline to 24 Weeks
Change in Number of Gastric Symptoms: No. of Symptoms
Mean change
Measured: Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2003 (estimated)
- Study startSep 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association Asthma Clinical Research Centers, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert Wise, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Robert Wise, Principal investigator, Johns Hopkins University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069823
- Sponsor's protocol ID
- 157
- Other IDs
- U01HL072968
- Status last verified
- Dec 2012
- First submitted
- 1 Oct 2003
- Last updated
- 19 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kaminsky DA, He J, Henderson R, Dixon AE, Irvin CG, Mastronarde J, Smith LJ, Sugar EA, Wise RA, Holbrook JT. Bronchodilator response does not associate with asthma control or symptom burden among patients with poorly controlled asthma. Respir Med. 2023 Nov;218:107375. doi: 10.1016/j.rmed.2023.107375. Epub 2023 Aug 1.
PubMed 37536444Bime C, Wei CY, Holbrook JT, Sockrider MM, Revicki DA, Wise RA. Asthma symptom utility index: reliability, validity, responsiveness, and the minimal important difference in adult asthmatic patients. J Allergy Clin Immunol. 2012 Nov;130(5):1078-84. doi: 10.1016/j.jaci.2012.07.058. Epub 2012 Sep 29.
PubMed 23026499Bime C, Wei CY, Holbrook J, Smith LJ, Wise RA. Association of dietary soy genistein intake with lung function and asthma control: a post-hoc analysis of patients enrolled in a prospective multicentre clinical trial. Prim Care Respir J. 2012 Dec;21(4):398-404. doi: 10.4104/pcrj.2012.00073.
PubMed 22885561DiMango E, Holbrook JT, Simpson E, Reibman J, Richter J, Narula S, Prusakowski N, Mastronarde JG, Wise RA; American Lung Association Asthma Clinical Research Centers. Effects of asymptomatic proximal and distal gastroesophageal reflux on asthma severity. Am J Respir Crit Care Med. 2009 Nov 1;180(9):809-16. doi: 10.1164/rccm.200904-0625OC. Epub 2009 Aug 6.
PubMed 19661245American Lung Association Asthma Clinical Research Centers; Mastronarde JG, Anthonisen NR, Castro M, Holbrook JT, Leone FT, Teague WG, Wise RA. Efficacy of esomeprazole for treatment of poorly controlled asthma. N Engl J Med. 2009 Apr 9;360(15):1487-99. doi: 10.1056/NEJMoa0806290.
PubMed 19357404
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Acid Reflux in Asthma
- ClinicalTrials.gov ID
- NCT00069823
- Acronym / sponsor ID
- 157
- Conditions
- Asthma, Lung Diseases, Lung Diseases, Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- American Lung Association Asthma Clinical Research Centers, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 3 Oct 2003 (estimated)
- Results
- Posted 19 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
Detailed description
BACKGROUND:
Gastroesophageal reflux (GERD) is frequent in asthmatics with poor asthma control, often occurs without symptoms, and can induce bronchoconstriction. Poorly controlled asthmatics are often treated for GERD with drugs that suppress gastric acid, but this treatment is expensive and the benefit of such treatment is not established. Proton pump inhibitors are a relatively new class of medications that provide highly effective treatment for GERD and associated problems. This success has led many doctors to begin PPI treatment in their asthma patients in an attempt to achieve better asthma control.
DESIGN NARRATIVE:
The randomized, placebo-controlled trial will enroll 400 asthmatics, ages 18 or older, who have poor asthma control on inhaled steroids, defined on the basis of excessive bronchodilator use, nocturnal awakenings, or frequent exacerbations. Participants will be randomly assigned to treatment with either a proton pump inhibitor, esomeprazole (Nexium) 40 mg twice a day, or matching placebo. The presence, severity, and temporal relationship of GERD to asthma symptoms will be documented with 24 hour ambulatory esophageal potential Hydrogen (pH) probe monitoring, but participants will be enrolled irrespective of the severity of GERD. The primary outcome measure is the proportion of participants who have exacerbations of asthma within a 6-month period defined by asthma diaries and interviews. Secondary outcome measures include asthma symptom and control scores, asthma-specific and generic health-related quality of life, GERD symptoms, health care use, pulmonary function, and airways reactivity. Pre-specified subgroup analyses will be conducted to determine if there are clinical or demographic characteristics that predict benefit from treatment of GERD in asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole | Experimental | Drug: EsomeprazoleProton pump inhibitor of gastric acid |
| Placebo for esomeprazoe | Placebo comparator | Drug: Placebo proton pump inhibitorPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The general goal of patient selection is to enroll patients for whom asthma physicians might prescribe GERD treatment, but where there is uncertainty whether it might be effective.
- Age 18 or older
- Physician diagnosed asthma
- If amount of air expired in the first second during a forced expiratory maneuver (FEV1) is greater than or equal to 70% predicted normal pre-bronchodilator: demonstrate methacholine 20% from post-diluent baseline (PC20). PC20 less than 16 mg/ml during Visit 1
- If FEV1 less than 70% and greater than or equal to 50% predicted normal pre-bronchodilator: demonstrate 12% reversibility during Visit 1 or within past 12 months
Key exclusion criteria (12 listed)
- Surgery: Previous anti-reflux or peptic ulcer surgery
- Pulmonary function: FEV1 less than 50% predicted normal pre-bronchodilator
- GERD Symptoms: Severe reflux constituting a clinical indication for treatment with a PPI or H2 blocker, typically two or more episodes per week of heartburn requiring antacids
- Other major chronic illnesses; conditions which in the judgment of the Study Physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, congestive heart failure, stroke, severe hypertension, Type 1 insulin dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, major neuropsychiatric disorder
- Medication use: Anti-reflux medication (proton pump inhibitors or H2 blockers) within 1 month Theophylline, azoles, iron, anti-coagulants, insulin (for Type I diabetes), digitalis, any investigative drugs within 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsomeprazoleAlso: NexiumProton pump inhibitor 40 mg orally twice daily | Drug | Esomeprazole |
| Placebo proton pump inhibitorPlacebo proton pump inhibitor | Drug | Placebo for esomeprazoe |
Primary outcome
Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion
Time frame: Baseline to 24 Weeks
Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma
17 secondary outcomes
Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days
Time frame: Baseline to 24 Weeks
Exacerbation Components: Urgent Care Visit
Time frame: Measured at Month 6
Exacerbation Components: New Use of Oral Corticosteroids
Time frame: Baseline to 24 Weeks
Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists
Time frame: Baseline to 24 Weeks
Use of Rescue Medications
Time frame: Baseline to 24 Weeks
Night Awakening
Time frame: Baseline to 24 Weeks
Pulmonary Function: Change in Prebronchodilator FEV1
Time frame: Baseline to 24 Weeks
Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity
Time frame: Baseline to 24 Weeks
Pulmonary Function: Change in Peak Flow Rate
Time frame: Baseline to 24 Weeks
Pulmonary Function: Change in PC20
Time frame: Baseline to 24 Weeks
Change in Juniper Asthma Control Score(JACQ)
Time frame: Baseline to 24 Weeks
Change in Asthma Symptom Utility Index (ASUI)
Time frame: Baseline to 24 Weeks
Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Time frame: Baseline to 24 Weeks
Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component
Time frame: Baseline to 24 Weeks
Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component
Time frame: Baseline to 24 Weeks
Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score
Time frame: Baseline to 24 Weeks
Change in Number of Gastric Symptoms: No. of Symptoms
Time frame: Baseline to 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37536444Kaminsky DA, He J, Henderson R, Dixon AE, Irvin CG, Mastronarde J, Smith LJ, Sugar EA, Wise RA, Holbrook JT. Bronchodilator response does not associate with asthma control or symptom burden among patients with poorly controlled asthma. Respir Med. 2023 Nov;218:107375. doi: 10.1016/j.rmed.2023.107375. Epub 2023 Aug 1.
- Derived from this study: PubMed 23026499Bime C, Wei CY, Holbrook JT, Sockrider MM, Revicki DA, Wise RA. Asthma symptom utility index: reliability, validity, responsiveness, and the minimal important difference in adult asthmatic patients. J Allergy Clin Immunol. 2012 Nov;130(5):1078-84. doi: 10.1016/j.jaci.2012.07.058. Epub 2012 Sep 29.
- Derived from this study: PubMed 22885561Bime C, Wei CY, Holbrook J, Smith LJ, Wise RA. Association of dietary soy genistein intake with lung function and asthma control: a post-hoc analysis of patients enrolled in a prospective multicentre clinical trial. Prim Care Respir J. 2012 Dec;21(4):398-404. doi: 10.4104/pcrj.2012.00073.
- Derived from this study: PubMed 19661245DiMango E, Holbrook JT, Simpson E, Reibman J, Richter J, Narula S, Prusakowski N, Mastronarde JG, Wise RA; American Lung Association Asthma Clinical Research Centers. Effects of asymptomatic proximal and distal gastroesophageal reflux on asthma severity. Am J Respir Crit Care Med. 2009 Nov 1;180(9):809-16. doi: 10.1164/rccm.200904-0625OC. Epub 2009 Aug 6.
- Derived from this study: PubMed 19357404American Lung Association Asthma Clinical Research Centers; Mastronarde JG, Anthonisen NR, Castro M, Holbrook JT, Leone FT, Teague WG, Wise RA. Efficacy of esomeprazole for treatment of poorly controlled asthma. N Engl J Med. 2009 Apr 9;360(15):1487-99. doi: 10.1056/NEJMoa0806290.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wise principal investigator
Johns Hopkins University School of Public Health
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Asthma and Lung Diseases, run by Johns Hopkins Bloomberg School of Public Health at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (time frame: Baseline to 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00069823, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2012; AzTrials last refreshed its copy on 3 Nov 2026.