Trial Outcomes & Findings for Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) (NCT NCT00000575)

Results Overview

Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1041 participants

Primary outcome timeframe

At the end of treatment, 4-6 years from baseline assessment

Results posted on

2014-04-03

Participant Flow

Between December 1993 and September 1995, 1041 children from 5 through 12 years of age with mild to moderate asthma at eight clinical centers (two HMOs associated with academic or research institutions and six located in specialty practices within academic or research institutions) were enrolled.

Patients were required to stop all asthma medications except as needed albuterol (prednisone could be used for asthma exacerbations) at the close of the second screening visit. Also at this time, patients began keeping a daily diary of asthma signs and symptoms, medications, school absences, and physician contacts.

Participant milestones

Participant milestones
Measure	1 Budesonide Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn	2 Nedocromil Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn	3 Placebo Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
Overall Study STARTED	311	312	418
Overall Study COMPLETED	311	312	418
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Budesonide n=311 Participants Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn	2 Nedocromil n=312 Participants Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn	3 Placebo n=418 Participants Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.	Total n=1041 Participants Total of all reporting groups
Age, Categorical <=18 years	311 Participants n=5 Participants	312 Participants n=7 Participants	418 Participants n=5 Participants	1041 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	9.0 years STANDARD_DEVIATION 2.1 • n=5 Participants	8.8 years STANDARD_DEVIATION 2.1 • n=7 Participants	9.0 years STANDARD_DEVIATION 2.2 • n=5 Participants	8.9 years STANDARD_DEVIATION 2.1 • n=4 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	106 Participants n=7 Participants	184 Participants n=5 Participants	420 Participants n=4 Participants
Sex: Female, Male Male	181 Participants n=5 Participants	206 Participants n=7 Participants	234 Participants n=5 Participants	621 Participants n=4 Participants
Region of Enrollment United States	274 participants n=5 Participants	274 participants n=7 Participants	368 participants n=5 Participants	916 participants n=4 Participants
Region of Enrollment Canada	37 participants n=5 Participants	38 participants n=7 Participants	50 participants n=5 Participants	125 participants n=4 Participants

PRIMARY outcome

Timeframe: At the end of treatment, 4-6 years from baseline assessment

Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.