Asthma Clinical Trial
Official title:
Childhood Asthma Management Program
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.
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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