Emory University researchers are recruiting patients for a national multi-site clinical trial to study whether treating acid reflux improves asthma symptoms.
Emory is one of twenty sites in the American Lung Association-Asthma Clinical Research Centers (ACRC) network participating in the Study of Acid Reflux and Asthma (SARA). The SARA trial is designed to determine whether asthma is worsened by gastroesophageal reflux disease (GERD or severe heartburn) and whether treatment of this condition using proton pump inhibitors improves asthma symptoms.
"It's not well known why there appears to be more GERD in asthmatics than in the general population, or whether the presence of GERD actually worsens asthma," says Sumita Khatri, MD, MS, an assistant professor in the division of pulmonary & critical care medicine, Emory University School of Medicine. "There are links experimentally between acid reflux and bronchial spasms related to asthma. In addition, bronchial spasms may increase reflux by altering pressures in the chest that may allow more acid to reflux into the esophagus. Asthma medications may also contribute to worsening GERD."
Dr. Khatri is the principal investigator of the SARA trial for the Emory site and co-principal investigator for the studies conducted through the ACRC. Emory pediatric pulmonologist Gerald Teague, MD, is the main principal investigator for the studies conducted through the ACRC.
Patients with asthma and some degree of continued asthma symptoms, who also have some signs of GERD are being sought for enrollment. Nine visits to either the Emory Children's Center or Emory Crawford Long Hospital over a six-month period are required from participants.
The national SARA trial will enroll 400 non-smoking 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, or matching placebo. The presence, severity, and temporal relationship of GERD to asthma symptoms will be documented with a 24-hour ambulatory esophageal pH probe test of the participant's esophagus to determine whether gastric acid washes back into the esophagus and causes symptoms. Interested participants who qualify and complete the study will receive between $600 and $650 for their time and effort.
For more information about eligibility requirements and exclusion factors for the SARA trial, contact Rachna Patel, MPH at Emory Children's Center at (404) 712-1773 or Jeannie Peabody, RN at Emory Crawford Long Hospital at (404) 686-1956.