CAMP Continuation Study / Phase 2

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

This application is for the Data Coordinating Center (DCC) for the Childhood Asthma Management Program Continuation Study/Phase 2 (CAMPCS/2). CAMPCS/2 will be carried out by 8 clinical centers and the DCC. The objectives, specific aims, and research plan for CAMPCS/2 are provided in the CAMPCS/2 application from Washington University (Robert Strunk, Principal Investigator), one of the 8 CAMP clinical centers submitting proposals. This application provides the objectives, specific aims, and research plan for the DCC. In CAMPCS/2, we propose following CAMP (Childhood Asthma Management Program) participants for an i additional 3.75 years. CAMP was a randomized, multicenter clinical trial of 3 therapies for childhood asthma inhaled albuterol alone, inhaled budesonide with albuterol, inhaled nedocromil with albuterol). CAMP participants were age 5-13 at randomization; follow-up during the trial phase lasted 3.5-5.5 years. Participants are currently being followed in an observational phase (CAMP Continuation Study or CAMPCS). Participants will be age 13 to 23 at the close of CAMPCS. At the end of CAMPCS/2 followup, participants will be age 16 to 27, with 91% of males and 92% of females age 18 or older. These data will answer questions in 3 areas: (1) the long-term effects of anti-inflammatory treatment for asthma on height and lung function in young adulthood; (2) the natural history of asthma from childhood into young adulthood; and (3) the genetics of asthma. The DCC will provide leadership, coordination, communication, organization, data management, quality assurance, facilitation, and biostatistical design and analysis expertise to support the CAMPCS/2 research team to complete patient follow-up and report findings. This application reviews the performance of the team in terms of data quality and quantity and publication of findings. Methods and procedures for CAMPCS/2 are I proposed with the aim of preserving the quality and comparability of measurements over time as was achieved in CAMP/CAMPCS. We outline the statistical methods needed for analysis of the CAMPCS/2 longitudinal data and show the adequacy of the sample size for addressing the scientific aims.