Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.
The hypothesis for this study is that potent anti-secretory therapy with high dose PPI improves asthma control regardless of either asthma severity or the presence of GERD symptoms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Double-blind Placebo Controlled Clinical Trial to Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.|
- Asthma symptoms
- Asthma quality of life
|Study Start Date:||September 2002|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Many patients with GERD do not experience heartburn symptoms. Barium esophagram, endoscopy and/or overnight esophageal pH monitoring are commonly relied upon to objectively establish the diagnosis of GERD. In general, overnight esophageal pH monitoring is the most sensitive and specific test available to confirm GERD. However, the literature exploring GERD as a cause of chronic cough suggests that the currently accepted criteria for defining abnormal overnight esophageal pH may not be adequately sensitive. It is therefore possible that aggressive GERD therapy may improve asthma control in patients with "normal" overnight esophageal pH probe results. To our knowledge, there are no published data addressing this question.
Primary Objective The primary objective is to compare asthma control in asthmatic subjects treated with high dose PPI with asthmatic subjects taking placebo PPI. The primary outcome variables will be measurements of asthma symptoms and asthma quality of life.
Secondary Objectives Secondary objectives include evaluating the effect of this aggressive anti-secretory therapy on lung function, asthma medication use (including both baseline and rescue medication), and GERD symptoms. An additional secondary objective will be to evaluate whether the presence or absence of GERD symptoms at baseline (prior to proton pump inhibitor therapy) will independently associate with improvement in any of the other outcomes measured.
Measurements will include: Juniper Asthma Control Questionnaire (visits 2 and 5), Juniper Asthma Quality of Life Questionnaire (visits 2 - 5), GSAS gastroesophageal reflux instrument (visit 2, visit 5), the occurrence of adverse events, change in FVC, FEF25-75%, MIF50 / MEF50, peak expiratory flow rate, FEV1 reversibility, and the physical exam.
Additional measurements will include methacholine challenge and eosinophilia in induced sputum specimens. Induced sputum will be offered to all patients, though it is anticipated that only approximately 50% will agree to this procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214552
|United States, Washington|
|Richland, Washington, United States, 99352|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Stephen A Tilles,, MD||ASTHMA, Inc.|