This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Gastroesophageal reflux (GERD) is frequent in asthmatics with poor asthma control, often occurs without symptoms, and 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. The objective of this proposal is to conduct a multi-site randomized clinical trial testing the hypothesis that treatment of GERD with proton pump inhibitors will reduce the rate of exacerbationsf in patients with inadequately controlled asthma. The proposed trial will enroll 400 asthmatics, ages 18-60, 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 R) 40 mg BID, 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 exacerbation rate of asthma defined by asthma diaries and interviews within a 6-month period. An exacerbation is defined as a decrease in morning peak flow of 30% or more for 2 consecutive days, addition of oral corticosteroid for control of asthma, or seeking urgent medical care for asthma symptoms. Secondary outcome measures include rate of asthma exacerbation using an expanded definition of exacerbation (the above definition plus increase use of rescue inhalers), asthma symptom and control scores, asthma-specific and generic health-related quality of life, GERD symptoms, health care use, pulmonary function, and airways reactivity. 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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