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

This study has been completed.
Sponsor:
Collaborators:
CAMP Steering Committee
Information provided by (Responsible Party):
James Tonascia, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000575
First received: October 27, 1999
Last updated: February 20, 2014
Last verified: February 2014
Results First Received: October 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Asthma
Lung Diseases
Interventions: Drug: Placebo
Drug: Nedocromil
Drug: Budesonide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    1 Budesonide     2 Nedocromil     3 Placebo  
STARTED     311     312     418  
COMPLETED     311     312     418  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    1 Budesonide     2 Nedocromil     3 Placebo     Total  
Number of Participants  
[units: participants]
  311     312     418     1041  
Age  
[units: participants]
       
<=18 years     311     312     418     1041  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  9.0  ± 2.1     8.8  ± 2.1     9.0  ± 2.2     8.9  ± 2.1  
Gender  
[units: participants]
       
Female     130     106     184     420  
Male     181     206     234     621  
Region of Enrollment  
[units: participants]
       
United States     274     274     368     916  
Canada     37     38     50     125  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs   [ Time Frame: 4-6 years from baseline ]

3.  Secondary:   Change From Baseline in the Rate of Asthma Free Days   [ Time Frame: 4-6 years from baseline ]

4.  Secondary:   Need for Urgent Care for Asthma   [ Time Frame: 4-6 years from baseline ]

5.  Secondary:   Mortality   [ Time Frame: 4-6 years from baseline ]

6.  Secondary:   Change in Height From Baseline to End of Treatment, 4-6 Years Later   [ Time Frame: 4-6 years from baseline ]

7.  Secondary:   Standardized Depression Scale -- Children's Depression Inventory   [ Time Frame: 4-6 years from baseline ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Alice Sternberg
Organization: Johns Hopkins Bloomberg School of Public Health, Dept of Epidemiology
phone: 410-955-3752
e-mail: asternbe@jhsph.edu


Publications:

Publications automatically indexed to this study:

Responsible Party: James Tonascia, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000575     History of Changes
Other Study ID Numbers: 213, 5U01HL075417
Study First Received: October 27, 1999
Results First Received: October 16, 2013
Last Updated: February 20, 2014
Health Authority: United States: Federal Government