Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)
The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Childhood Asthma Management Program|
- Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period [ Time Frame: At the end of treatment, 4-6 years from baseline assessment ] [ Designated as safety issue: No ]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.
- Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]Bronchial responsiveness to serial concentrations of inhaled methacholine solution (mg/ml) as measured by serial ratios of follow-up to baseline FEV1 (forced volume of air expired from the lungs in one second). A dose-response curve is calculated from the serial ratios in relation to the serial concentrations to determine PC20, the concentration associated with a 20% drop from baseline in FEV1; this PC20 is the outcome measure with units mg/ml of methacholine.
- Change From Baseline in the Rate of Asthma Free Days [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]Change from baseline proportion of days without asthma symptoms or other asthma related events to proportion of days during the 4-6 years of follow-up. Asthma free days were determined from daily asthma diaries kept from baseline to the end of treatment, 4-6 years later.
- Need for Urgent Care for Asthma [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]Counts during the period of treatment (4-6 years) of visits to emergency rooms or equivalent urgent care settings for asthma treatment.
- Mortality [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: Yes ]Counts of deaths from asthma.
- Change in Height From Baseline to End of Treatment, 4-6 Years Later [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]Change in standing height from baseline to end of treatment. Standing height is measured three times without shoes using a calibrated Harpenden stadiometer; the average of the three repeated heights to the nearest 0.1 cm is the height measure at either baseline or end of treatment.
- Standardized Depression Scale -- Children's Depression Inventory [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]Change in total score on the Children's Depression Inventory from baseline to the end of treatment, 4-6 years later. The total score ranges from 0-54 with higher scores indicating greater levels of depression.
|Study Start Date:||September 1991|
|Study Completion Date:||March 2012|
|Primary Completion Date:||October 1999 (Final data collection date for primary outcome measure)|
Active Comparator: 1 Budesonide
Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
Other Name: Pulmicort
Active Comparator: 2 Nedocromil
Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
Four 2 mg puffs bid + two 90 Og puffs albuterol prn
Other Name: Tilade
Placebo Comparator: 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.
Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn OR four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000575
|Principal Investigator:||N. F. Adkinson, MD||Johns Hopkins University|
|Principal Investigator:||Anne Fuhlbrigge, MD, MS||Brigham and Women's Hospital|
|Principal Investigator:||H. W. Kelly, PharmD||University of New Mexico|
|Principal Investigator:||Padmaja Subbarao, MD, MSc||The Hospital for Sick Children|
|Principal Investigator:||Paul Williams, MD||Asthma, Inc.|
|Principal Investigator:||Robert Strunk, MD||Washington University School of Medicine|
|Principal Investigator:||Stanley Szefler, MD||National Jewish Health|
|Principal Investigator:||James Tonascia, PhD||Johns Hopkins University|
|Principal Investigator:||Robert Zeiger, MD, PhD||University of California, San Diego|