Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272506
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2006-01-03
Brief Title:
Pediatric Asthma Controller Trial PACT
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-01
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:
None
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 72 percent compared to 51 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 450000 hospitalizations 5000 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
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 72 percent compared to 51 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 450000 hospitalizations 5000 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: