Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) (CAMP)
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|ClinicalTrials.gov Identifier: NCT00000575|
Recruitment Status : Completed
First Posted : October 28, 1999
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asthma Lung Diseases||Drug: Placebo Drug: Nedocromil Drug: Budesonide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1041 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Childhood Asthma Management Program|
|Study Start Date :||September 1991|
|Actual Primary Completion Date :||October 1999|
|Actual Study Completion Date :||March 2012|
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.
- 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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|