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Prevention of Early Asthma in Kids (PEAK)

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ClinicalTrials.gov Identifier: NCT00272441
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Childhood Asthma Research and Education Network
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE January 3, 2006
First Posted Date  ICMJE January 6, 2006
Last Update Posted Date July 12, 2016
Study Start Date  ICMJE January 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Early Asthma in Kids (PEAK)
Official Title  ICMJE Not Provided
Brief Summary To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.
Detailed Description

BACKGROUND:

Asthma is a complex disease that often starts early in life. Exacerbations can be triggered by a number of agents such as allergens, respiratory infections, environmental tobacco smoke and pollutants, drugs, chemicals, exercise, cold air, infections and strong emotion making asthma therapy difficult and sometimes complicated. Multiple medications are often required to treat symptoms (bronchodilator agents such as beta-2 adrenergic agonists, theophylline, and anticholinergics), as well the underlying disease process (anti-inflammatory agents such as inhaled and systemic corticosteroids, cromolyn sodium and nedocromil; and leukotriene modifiers).

The prevalence of asthma is increasing in all age groups, but most particularly in children under the age of 18 years. In 1992, the prevalence of self-reported asthma among persons under 18 years of age was 7.2 percent, compared to 5.1 percent among all persons. The most rapid increase in asthma has occurred in children under 5 years old, with rates increasing over 160 percent over the past 15 years. Among all ages, over 450,000 hospitalizations, 5,000 deaths, and more than 100 million days of restricted activity are due to asthma every year. Yet the burden of asthma disproportionately affects children. For example, asthma hospitalization rates are highest among persons age 0-4 years, and have increased over 28 percent in the last 15 years; mortality rates increased faster among those aged 5 to-12 years than among those age 15-34 years and neither changes in disease coding nor improved recognition of asthma fully explain these increases. Nearly one third of children restrict their activities due to asthma, including participation in physical education and sports.

Despite major advances in understanding the etiology and pathophysiology of asthma and the development of new therapeutic modalities to control symptoms and prevent exacerbations, effective therapies are not widely used in the pediatric health care community. Further, the long term effects and side effects of asthma medications in children, especially children under the age of 12 years, are not well understood. Much remains to be learned about the impact of asthma therapy at different ages and at different points in the natural history of the asthma in altering the progression, chronicity, or severity of the disease.

There is an urgent need to rapidly evaluate new and existing therapeutic approaches for children with asthma, and to disseminate the findings to health care professionals, patients and the public. There are several reasons why a pediatric asthma clinical research network will accelerate clinical research and meet this need. The highly variable and sometimes complicated clinical manifestations of asthma often make it difficult to accumulate a large number of comparable patients in one center. Further, uniformity in treatment protocols may reduce the number of patients needed at each clinical center. Also, the network mechanism will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple and novel therapeutic trials in a timely, efficient manner. This, in turn, would promote rapid dissemination of research findings to health care professionals.

DESIGN NARRATIVE:

Prevention of Early Asthma in Kids (PEAK) began recruitment in January 2001 and evaluated whether administering inhaled corticosteroids to 24-48 month old children at risk of developing asthma prevented the development of persistent asthma. All subjects were expected to be randomized prior to December 2001 with study completion by September 2004. The study was a double blind, randomized, placebo controlled, parallel comparison of inhaled fluticasone to placebo. There was a four week run-in period to qualify and characterize children. A total of 285 children were randomized to one of two treatment groups; one receiving active treatment, the other placebo. The study was based on a continuous treatment schedule for a period of twenty-four months, followed by an observation period of one year during which the main outcomes were assessed. The primary outcome measure was the number of asthma-free days. Secondary outcomes included number of exacerbations, use of asthma medications, and lung function. There were three specific objectives of the study: 1) To assess if chronic therapy with inhaled corticosteroids initiated in children four years or less at high risk of developing asthma can prevent the development of significant asthma at four to six years of age, 2) To determine if asthma therapy as described above can prevent both losses in lung function and the development of bronchial hyperresponsiveness (BHR) associated with early onset asthma, and 3) To assess potential side effects that may be associated with long term use of inhaled steroids in early life. PEAK study outcomes were presented at the 2005 annual meetings of the American Academy of Allergy, Asthma, and Immunology and the American Thoracic Society. A manuscript has been submitted for publication by the New England Journal of Medicine.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Lung Diseases
Intervention  ICMJE Drug: inhaled corticosteroids
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Asthmatic children from birth to 18 years. Emphasis is placed on infants and young children through 5 years of age.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00272441
Other Study ID Numbers  ICMJE 350
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Childhood Asthma Research and Education Network
Investigators  ICMJE
Investigator: Vernon Chinchilli Milton S. Hershey Medical Center
Investigator: Robert Lemanske University of Wisconsin, Madison
Investigator: Fernando Martinez University of Arizona
Investigator: Robert Strunk Washington University School of Medicine
Investigator: Stanley Szefler National Jewish Health
Investigator: Robert Zeiger University of California, San Diego
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP