Abstract
The Childhood Asthma Management Program (CAMP) is a multicenter, randomized, double-masked clinical trial designed to determine the long-term effects of three inhaled treatments for mild to moderate childhood asthma: budesonide (a glucocorticoid used daily) and albuterol (a short-acting β-agonist bronchodilator used as needed); nedocromil (a nonsteroid anti-inflammatory agent used daily) and albuterol; and placebo and albuterol. One thousand forty-one children (32% from ethnic minority groups), aged 5 to 12 years at screening, are currently participating. The primary outcome measure is lung growth as indicated by postbronchodilator forced expiratory volume in 1 second (FEV1) percent of predicted, observed over 5- to 6-year period. The trial also assesses differences between treatment groups with respect to airway responsiveness, morbidity, physical growth and development, and psychological growth and development. This report describes the design of the trial, the rationale for the design choices made, and the methods used to carry out the trial.
Original language | English (US) |
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Pages (from-to) | 91-120 |
Number of pages | 30 |
Journal | Controlled Clinical Trials |
Volume | 20 |
Issue number | 1 |
DOIs | |
State | Published - Feb 1999 |
Externally published | Yes |
Funding
The Childhood Asthma Management Program is supported by Contracts NO1-HR-16044, 16045, 16046, 16047, 16048, 16049, 16050, 16051, and 16052 with the National Heart, Lung, and Blood Institute. Appendix The members of the CAMP Research Group as of February 1998 are as follows.
Keywords
- Albuterol
- Allergens
- Anti-inflammatory agents
- Atopy
- Bronchial provocation test
- Bronchodilator agents
- Budesonide
- Childhood asthma
- Clinical trials
- Environmental exposure
- Glucocorticoids
- Growth
- Inhaled bronchodilator
- Nedocromil
- Psychological test
- Spirometry
ASJC Scopus subject areas
- Pharmacology