Asthma Clinical Trial
Official title:
Childhood Asthma Research and Education (CARE) Network
The purpose of this study is 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.
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 as 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 to 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 aged 15 to 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. Furthermore,
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. Furthermore, 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:
This is a multicenter study performing multiple therapeutic trials for children with asthma.
One outcome of the Network will be to promote rapid dissemination of the findings from these
clinical studies to the health care community. Therapeutic trials may involve
investigational drugs, drugs already approved but not currently used in childhood asthma,
and drugs currently used in the treatment of asthma. The Network ends in May 2009.
The following protocols are under way or have been completed:
Prevention of Early Asthma in Kids (PEAK) began recruitment in January 2001 and evaluated
whether administering inhaled corticosteroids (ICS) to 24- to 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 4-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 24 months, followed by an observation period of 1 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. The study has three specific objectives: (1) to assess if chronic therapy
with ICS initiated in children 4 years or less at high risk of developing asthma can prevent
the development of significant asthma at 4 to 6 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.
Characterizing the Response to Leukotriene Antagonist and Inhaled Corticosteroids (CLIC)
began in August 2001 in children ages 6 to 17 with mild to moderate asthma. The study was a
randomized, double-blind crossover comparing montelukast to inhaled fluticasone propionate
in mild-to-moderate persistent asthma in 144 children. There was a 5- to 10-day run-in
period to qualify and characterize patients. Children were randomized to one of two
crossover treatment sequences with 8-week periods of either an active ICS, fluticasone
propionate, or an active leukotriene receptor antagonist (LTRA), montelukast. During the
active treatment period for one drug, the participant received a placebo for the alternative
drug. The first 4 weeks of the second treatment period were considered a sufficient period
for washout of study medication used in the first period of each treatment sequence. The two
crossover sequences were stratified according to clinical center, age category, and FEV1
percent predicted category by using the minimization method of randomization. Outcome
parameters were determined every 4 weeks during the 16-week treatment phase. The primary
outcome measure was percentage change in prebronchodilator FEVI from baseline to the end of
each treatment period. Results were published in the February 2005 issue of the Journal of
Allergy and Clinical Immunology.
Acute Intervention Management Strategies (AIMS) is a randomized, double-blind, double-dummy,
placebo-controlled parallel comparison study to determine if the initiation of an ICS or
LTRA with an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness
(RTI)-associated symptoms increases the proportion of symptom-free days over the entire
treatment period during the 5- to 9-month study period. There will be a 2-week period to
qualify and characterize children who at this time have no lower respiratory tract symptoms
other than mild cough. A total of 244 children were randomized to one of three treatment
groups and followed for the remainder of the fall-winter-early spring season, during which
participants received one of the following regimens for 7 days at the first sign of
RTI-associated symptoms: (1) active ICS and placebo LTRA and albuterol inhalation treatments
four times daily; (2) active LTRA and placebo ICS and albuterol inhalation treatment four
times daily; or (3) placebo ICS and placebo LTRA and albuterol inhalation treatments four
times daily.
Pediatric Asthma Controller Trial (PACT) is a study to determine the comparative
effectiveness of ICS, an LTRA, or a combination medication of ICS 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.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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