Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00272506 |
Other study ID # |
351 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
January 3, 2006 |
Last updated |
July 11, 2016 |
Start date |
August 2002 |
Est. completion date |
September 2004 |
Study information
Verified date |
January 2006 |
Source |
National Heart, Lung, and Blood Institute (NHLBI) |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
United States: Federal Government |
Study type |
Interventional
|
Clinical Trial 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.
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:
Pediatric Asthma Controller Trial (PACT) is a study to determine the comparative
effectiveness of inhaled corticosteroid, a leukotriene receptor antagonist, or a combination
medication of inhaled corticosteroid and long-acting beta2-agonist in children with mild
asthma. The study addresses a critical question facing primary care physicians about the
optimal choice for initiating daily long-term treatment in children. The primary study
outcome is the percentage of days without asthma during the 12-month treatment period.
Recruitment began in August, 2002. A total of 300 children were assigned to one of three
active treatment arms for 12 months: active ICS; a combination of active ICS and salmeterol;
or active montelukast (LTRA). Major outcomes on the follow-up of 277 children were presented
in May, 2005 at the American Thoracic Society meeting.
The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).