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| Descriptive Information Fields | |||||
| Brief Title † | Study of Acid Reflux in Asthma | ||||
| Official Title † | The Study of Acid Reflux in Asthma | ||||
| Brief 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. |
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| 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 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Proportion of participants who have exacerbations of asthma, as defined by asthma diaries and interviews [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Asthma symptom and control scores [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Asthma specific and generic health related quality of life [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] GERD symptoms [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Health care use [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Pulmonary function [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Airway reactivity [ Time Frame: Measured at 24 weeks ] [ Designated as safety issue: No ] |
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| Condition † | Asthma Lung Diseases Lung Diseases, Obstructive |
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| Intervention † | Drug: Esomeprazole Drug: Placebo proton pump inhibitor |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 400 | ||||
| Start Date † | September 2003 | ||||
| Completion Date | May 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00069823 | ||||
| Organization ID | 157 | ||||
| Secondary IDs †† | U01 HL72968 | ||||
| Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators †† | American Lung Association Asthma Clinical Research Centers | ||||
| Investigators † |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | October 1, 2003 | ||||
| Last Updated Date | July 18, 2008 | ||||