39th Multicenter Airway Research Collaboration (MARC-39)
Kohei Hasegawa, MD, MPH (Principal Investigator)
Carlos A. Camargo, Jr., MD, DrPH (Co-Investigator)
Daniel J Pallin, MD, MPH (Site Investigator, Brigham and Women’s Hospital)
Nathan I. Shapiro, MD, MPH (Site Investigator, Beth Israel Deaconess Medical Center)
Catalina Gimenez-Zapiola, BA (Project Coordinator)
Funded by a grant from Teva Pharmaceuticals to MGH (Kohei Hasegawa, PI). Teva has no role in the conduct of the study nor collection, management, or analysis of data.
Primary Objective: The primary objective of this study is to determine the change in proportion of ED visits made by adults with acute asthma who report they ran-out of their SABA rescue inhaler before presenting to the ED in Boston between the pre-inhaler dose counter era and the present dose counter predominant era.
Secondary Objectives: The secondary objectives of the study are as follows:
- To examine the change in the characteristics of ED patients with acute asthma between the pre-inhaler dose counter era and the present dose counter predominant era
- To examine the ED asthma patients’ technique in using their SABA inhalers in 2015-2016
- To examine the changes in the methods used by the ED asthma patients to identify how many doses remain in their SABA inhalers between the pre-inhaler dose counter era and the present dose counter predominant era
- To examine the association between SABA inhaler ran-out status and acute asthma outcomes, such as a) hospitalization and b) relapse
Design and Setting: This is a multicenter, observational cohort study of adults, age 18-54 years, who present with acute asthma to the ED. It will build on the success of prior Multicenter Airway Research Collaboration (MARC) studies by updating previously collected observational data from 3 large academic EDs in Boston (Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, and Massachusetts General Hospital). Site research staff will enroll 400 participants between approximately October 1, 2015 and approximately September 30, 2016; each site will need to enroll 33-34 participants in each 3-month period (October to December, January to March, April to June, and July to September) to meet the overall enrollment goal of 400 participants. All patients will be managed at the discretion of the treating physician.
Study Population: Adults 18 to 54 years of age presenting to the ED with acute asthma, with a history of asthma before the index ED visit, and the ability to give informed consent. Study data will be collected for the first visit of consecutive patients only, ie, repeat ED visits within the study period will be excluded.
Study Period: 12 months; starting approximately October 1, 2015 and ending approximately September 30, 2016
Study Endpoints: The primary study endpoint is the proportion of ED adults with acute asthma who report they ran-out of their SABA rescue inhaler during the 7 days before the index ED visit in 2015-2016, compared to data from the same 3 EDs in the late 1990s.
The secondary study endpoints are:
- The characteristics of the adults with acute asthma who ran-out of their SABA inhalers during the 7 days before the index ED visit in 2015-2016, compared to data from the same 3 EDs in the late 1990s
- The patients’ technique in using their SABA inhaler in 2015-2016
- The methods used by the ED patients to identify how many doses remain in their SABA inhalers in 2015-2016, compared to data from the early 2000s from families chosen from the Allergy & Asthma Network / Mothers of Asthmatics (AANMA).
- Relationship of SABA inhaler ran-out status to outcome of acute asthma during the 2-week follow-up period: hospitalization and relapse