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|
- To determine the long-term effects of 3 treatments (either of two classes of anti-inflammatory agents [budesonide or nedocromil] and placebo) on pulmonary function as measured by normalized FEV1 over a 5-6.5 year period in children with asthma [ Time Frame: Measured every 4 months ] [ Designated as safety issue: No ]
- To determine if the three treatments differ with respect to the long-term effects on bronchial responsiveness to methacholine [ Time Frame: Measured once per year ] [ Designated as safety issue: No ]
- Difference between the three treatments with respect to morbidity; measured by PEFR, frequency & severity of asthma symptoms, days of limited activity, nocturnal awakenings, use of albuterol & prednisone to control symptoms, and pulmonary function [ Time Frame: Measured through the use of daily patient diaries ] [ Designated as safety issue: No ]
- To determine if the three treatments differ with respect to use of health care resources such as emergency room visits, hospitalizations, and physician contacts [ Time Frame: Measured every 4 months ] [ Designated as safety issue: No ]
- To determine if the three treatments differ with respect to mortality, long-term safety, and side effects [ Time Frame: Measured every 4 months ] [ Designated as safety issue: Yes ]
- To determine if the three treatments differ with respect to physical growth and development as indicated by sexual maturation, growth rates, and bone density [ Time Frame: Sexual maturation & bone density measured annually; growth rates measured every 4 months ] [ Designated as safety issue: No ]
- To determine if the three treatments differ with respect to psychological growth and development as indicated by measures of neurocognitive functioning and psychological adjustment [ Time Frame: Measured at baseline and Years 3 and 5 ] [ Designated as safety issue: No ]
- To determine the influence of environmental and psychological factors and atopic status in response to the different treatments [ Time Frame: Environmental questionnaire used to measure annually; skin testing at baseline and Year 5 ] [ Designated as safety issue: No ]
|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 Og puffs bid + two Og 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 Og puffs albuterol prn
Four 2 mg puffs bid + two 90 Og puffs albuterol prn
Other Name: Tilade
Placebo Comparator: 3 Placebo
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.
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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Asthma is a serious chronic condition, affecting approximately 14 million Americans. People with asthma experience well over 100 million days of restricted activity annually, and costs for asthma care exceed $10 billion a year. Asthma is much more prevalent among children than adults.
Hospitalizations for asthma have been increasing among children. For example, from 1979 to 1987, the hospital discharge rate with asthma as the first-listed diagnosis rose 43 percent among children less than 15 years of age, from 19.8 to 28.4 discharges per 10,000 population.
Death rates for asthma are greater in Blacks than in whites, and the difference is increasing. In 1979, Blacks of both sexes were about twice as likely to die from asthma as whites. Over the past decade this ratio has increased, and by 1987 the asthma death rate was almost three times greater among Blacks than whites. In children, these mortality differences between Blacks and whites are even more striking.
Current knowledge about the epidemiology and natural history of childhood asthma is incomplete, but the relationship between asthma early in life and development of chronic obstructive pulmonary disease (COPD) in adulthood is becoming more apparent. Asthmatic children with persistent and severe asthma symptoms have lower levels of lung function by young adulthood than those with milder disease. Recent longitudinal studies have confirmed a decrease in rate of growth of lung function as measured by FEV1 among symptomatic (primarily wheeze) children compared to asymptomatic children. Among persons who develop COPD, initial level of lung function is the strongest predictor of subsequent rapid decline of ventilatory function.
Thus, less than maximally attained levels of lung function among children with asthma may predispose them to greater than normal decline of lung function later in life. Although the long-term effect of treatment on the course of asthma is not known, the treatment goal of decreasing bronchial hyperresponsiveness and maximizing lung function and growth during childhood may have a beneficial effect on lung health throughout life and prevent progression to irreversible airflow obstruction.
Two classes of medications are currently available for treatment of inflammation--corticosteroids and cromolyn sodium. Inhaled corticosteroids have significantly fewer side effects than systemic administration. Corticosteroids do not inhibit the early asthmatic response, but are effective in suppressing the inflammation and bronchial hyperresponsiveness of the late phase response. Long-term studies of inhaled corticosteroids have shown beneficial effects on lung function as measured by FEV1. However, there has been concern about possible effects of long-term use of inhaled corticosteroids. Although epidemiological studies of the use of inhaled corticosteroids have shown no significant adverse effects, large-scale randomized controlled studies of their effects on children's growth and development are needed.
When CAMP was initiated in the United States, bronchodilator treatment was the most common approach to therapy. Two classes of bronchodilators, inhaled beta-2-adrenergic agonists and oral theophylline, are most frequently prescribed for asthma. To date, no randomized, controlled studies have compared the two classes of anti-inflammatory medications to each other and to bronchodilator therapy on the course of asthma.
The initiative was proposed by the Pulmonary Disease Advisory Committee working group in October 1987 and approved by the full committee at the February 1988 meeting and by the National Heart, Lung, and Blood Advisory Council in May 1990. The Request for Proposals was released in October 1990. Awards were made in September 1991.
Children were randomized to one of three treatment groups to receive either: inhaled albuterol alone, albuterol with inhaled budesonide, albuterol with nedocromil. Upon randomization, data were collected on demographic factors, physical and psychosocial development, clinical factors including medical history and extent of allergies, and quality of life factors including limitation of activity, absenteeism from school, emergency room visits, and hospitalizations. All subjects received a common educational program, differing only in the information presented regarding the medication used by the subjects. Each subject was given a standard protocol for dealing with asthma attacks. All subjects were treated and followed for five years with quarterly visits yearly. Recruitment began in July 1993 and ended in June 1995 with the accrual of 1,041 subjects.
The study has been extended through June 2011 through three funding phases to observe the subjects but not provide asthma treatment. This will allow CAMP to (1.) determine the full impact of 4 to 6 years of anti-inflammatory therapy on attaining maximal lung function and final height; (2.) examine the natural history of asthma through age 26; and (3.) define patterns of reduced lung function growth and early decline of lung function in young adults.
|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|