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The data for this project come from the Childhood Asthma Management Program (CAMP), a clinical trial carried out in children with asthma. The trial was designed to determine the long-term effects of 3 treatments (budesonide, nedocromil, or placebo) on pulmonary function as measured by normalized FEV1 over a 5-6.5 year period. The CAMP study also followed participants after the treatment trial to understand potential impacts of long-term steroid treatment of lung development in children.
The design of CAMP was a multicenter, masked, placebo-controlled, randomized trial. A total of 685 children (210 in the budesonide group, 210 in the nedocromil group and 275 in the placebo group) aged 5-12 years were enrolled between December of 1993 and September of 1995. Participants were treated for up to 5-6.5 years. The same outcome measurements were collected after the treatment trial ended (CAMP-CS study) for an additional 4.5 years.
The primary outcome of the trial was lung function as measured by the Forced Expiratory Volume at 1 second (FEV1). Secondary outcomes were FEV1/FVC and bronchial responsiveness to a bronchodilator.
Biologically it isn’t clear whether the treatments take immediate effect, have increased effects over time, or if the treatment effect wears off. What we learned in project 1 is that at 5 years there is little difference in FEV1 between treatments? However, it remains an open question whether there was more impact earlier in the study and the effect on secondary measures.
Does either treatment impact the primary or secondary outcomes differentially over the treatment period and how do these patterns compare to pattern of the primary or secondary outcomes over time in control children? Additionally, are the patterns in the primary or secondary outcomes different between the treatment groups and the controls after treatment ends?
The data and a data dictionary can be found on canvas under the Project 1 assigment.