Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)
This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000575
First received: October 27, 1999
Last updated: September 16, 2011
Last verified: September 2011
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Purpose
Show Detailed Description
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 3 |
Study Type: | Interventional |
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 |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Budesonide
Nedocromil
Nedocromil sodium
Nedocromil calcium
Levalbuterol tartrate
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 2012 |
Primary Completion Date: | October 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1 Budesonide
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.
Other Name: Pulmicort
|
Active Comparator: 2 Nedocromil
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
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.
|
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.
|
Show Detailed Description
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
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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 14, 2013
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Virginia Taggart, Project Officer, NHLBI |
ClinicalTrials.gov Identifier: | NCT00000575 History of Changes |
Other Study ID Numbers: | 213 |
Study First Received: | October 27, 1999 |
Last Updated: | September 16, 2011 |
Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
Asthma Lung Diseases Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Nedocromil Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on February 14, 2013