Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Nedocromil; Budesonide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; Four 2 mg puffs bid + two 90 Og puffs albuterol prn; Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
Other intervention name(s): Tilade; Pulmicort
Intervention MeSH terms: Nedocromil; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment