Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000575
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
1999-10-27
Brief Title:
Childhood Asthma Management Program CAMP Phases I Trial II CAMPCS III CAMPCS2 and IV CAMPCS3
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Childhood Asthma Management Program
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
Brief 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 198 to 284 discharges per 10000 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 childrens 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 1041 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
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 198 to 284 discharges per 10000 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 childrens 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 1041 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01HL075417 | NIH | None | httpsreporternihgovquickSearch5U01HL075417 |