Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000575

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00000575

Purpose

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.

Condition	Intervention	Phase
Asthma Lung Diseases	Drug: Placebo Drug: Nedocromil Drug: Budesonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Childhood Asthma Management Program

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Nedocromil Nedocromil sodium Nedocromil calcium

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	1041
Study Start Date:	September 1991
Estimated Study Completion Date:	June 2011
Primary Completion Date:	October 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Budesonide: Active Comparator Budesonide (Pulmicort), two 100 Og puffs bid + two Og puffs albuterol (Ventolin) prn	Drug: Budesonide Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
2 Nedocromil: Active Comparator Nedocromil (Tilade), four 2 mg puffs bid + two 90 Og puffs albuterol prn	Drug: Nedocromil Four 2 mg puffs bid + two 90 Og puffs albuterol prn
3 Placebo: Placebo Comparator 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.	Drug: 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.

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Eligibility

Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Age 5 to 12 years at time of screening
Chronic asthma as evidenced by one or more of the following historical findings for at least 6 months during the past year:
Asthma symptoms at least 2 times per week
2 or more usages per week of an inhaled bronchodilator
Daily asthma medication
Current asthma symptoms either by diary symptom code of 1 or greater or am or pm PEFR less than 80% of personal best post-bronchodilator value by diary, on 8 or more days during the prn screening period
Methacholine sensitivity: estimated PC20 FEV1 less than or equal to 12.5 mg/ml
Consent of guardian and assent of child
Ability to comply with trial for 5 - 6.5 years

Exclusion criteria:

Presence of one or more of the following confounding or complicating problems:
Any other active pulmonary disease
Any chronic condition presumed to interfere with the successful completion of the project or confound its interpretation
Pulmonary function testing findings suggesting a ventilatory defect other than asthma, or evidence of existing irreversible lung damage
Severe chronic sinusitis or nasal polyposis
Introduction of or a change in allergen immunotherapy within the past month
Use of more than 4 sprays of nasal steroids daily (only beclomethasone allowed)
Pregnancy
Current use of metoclopramide, ranitidine, or cimetidine
Treatment for gastroesophageal reflux
Participation in another drug study
Evidence of severe asthma as indicated by one or more of the following:
Two or more hospitalizations for asthma in the past year
Six or more steroid bursts in the past year
Demonstrated need for continuous use of glucocorticoids, either oral or inhaled
When off inhaled O2-agonist for more than 4 hrs and theophylline for more than 24 hrs, FEV1 less than 65% predicted
Intubation for asthma at any time in the past
Need for 9 or more puffs/day of albuterol for each of 3 consecutive days (excluding preventive use prior to exercise), or nocturnal asthma awakenings more than 1.5 times per week on average, or average diary card symptom code greater than 2, or requirement for other medications to control asthma, during prn screening period
Inability to perform 3 acceptable FVC maneuvers of which at least 2 reproducible FEV1s are within 10% of the largest FEV1
Inability to complete the methacholine challenge or methacholine PC20 FEV1 greater than 12.5 mg/ml
Evidence that patient or family may be unreliable or non-compliant or may move from the metropolitan area before trial completion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000575

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Responsible Party:	NHLBI ( Virginia Taggart, Project Officer )
Study ID Numbers:	213
Study First Received:	October 27, 1999
Last Updated:	July 16, 2009
ClinicalTrials.gov Identifier:	NCT00000575 History of Changes
Health Authority:	United States: Federal Government