Terminé

CAMPGestion de l'asthme pédiatrique avec des médicaments inhalés

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
But de l'étude

Cette étude vise à évaluer l'efficacité des médicaments inhalés dans la prise en charge de l'asthme chez l'enfant sur une période de 4 à 6 ans, en se concentrant spécifiquement sur les améliorations de la fonction pulmonaire mesurées par le FEV1 normalisé après l'utilisation d'un bronchodilatateur.

Ce qui est testé

Budesonide : Une aide à la respiration

+ Utilisation du Nedocromil pour le traitement

+ Traitement par placebo pour l'asthme

Médicament
Qui peut participer

Maladies bronchiques+6

+ Hypersensibilité

+ Hypersensibilité immédiate

De 5 à 12 ans
+30 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Groupe PlaceboPhase 3
Interventionnel
Date de début : septembre 1991
Voir le détail du protocole

Résumé

Sponsor principalJohns Hopkins Bloomberg School of Public Health
Dernière mise à jour : 3 avril 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 septembre 1991

Date à laquelle le premier participant a commencé l'étude.

BACKGROUND: Asthma is a serious chronic condition, affecting approximately 14 million Americans. People with asthma experience well over 100 million days of restricted activity annually, and costs for asthma care exceed $10 billion a year. Asthma is much more prevalent among children than adults. Hospitalizations for asthma have been increasing among children. For example, from 1979 to 1987, the hospital discharge rate with asthma as the first-listed diagnosis rose 43 percent among children less than 15 years of age, from 19.8 to 28.4 discharges per 10,000 population. Death rates for asthma are greater in Blacks than in whites, and the difference is increasing. In 1979, Blacks of both sexes were about twice as likely to die from asthma as whites. Over the past decade this ratio has increased, and by 1987 the asthma death rate was almost three times greater among Blacks than whites. In children, these mortality differences between Blacks and whites are even more striking. Current knowledge about the epidemiology and natural history of childhood asthma is incomplete, but the relationship between asthma early in life and development of chronic obstructive pulmonary disease (COPD) in adulthood is becoming more apparent. Asthmatic children with persistent and severe asthma symptoms have lower levels of lung function by young adulthood than those with milder disease. Recent longitudinal studies have confirmed a decrease in rate of growth of lung function as measured by FEV1 among symptomatic (primarily wheeze) children compared to asymptomatic children. Among persons who develop COPD, initial level of lung function is the strongest predictor of subsequent rapid decline of ventilatory function. Thus, less than maximally attained levels of lung function among children with asthma may predispose them to greater than normal decline of lung function later in life. Although the long-term effect of treatment on the course of asthma is not known, the treatment goal of decreasing bronchial hyperresponsiveness and maximizing lung function and growth during childhood may have a beneficial effect on lung health throughout life and prevent progression to irreversible airflow obstruction. Two classes of medications are currently available for treatment of inflammation--corticosteroids and cromolyn sodium. Inhaled corticosteroids have significantly fewer side effects than systemic administration. Corticosteroids do not inhibit the early asthmatic response, but are effective in suppressing the inflammation and bronchial hyperresponsiveness of the late phase response. Long-term studies of inhaled corticosteroids have shown beneficial effects on lung function as measured by FEV1. However, there has been concern about possible effects of long-term use of inhaled corticosteroids. Although epidemiological studies of the use of inhaled corticosteroids have shown no significant adverse effects, large-scale randomized controlled studies of their effects on children's growth and development are needed. When CAMP was initiated in the United States, bronchodilator treatment was the most common approach to therapy. Two classes of bronchodilators, inhaled beta-2-adrenergic agonists and oral theophylline, are most frequently prescribed for asthma. To date, no randomized, controlled studies have compared the two classes of anti-inflammatory medications to each other and to bronchodilator therapy on the course of asthma. The initiative was proposed by the Pulmonary Disease Advisory Committee working group in October 1987 and approved by the full committee at the February 1988 meeting and by the National Heart, Lung, and Blood Advisory Council in May 1990. The Request for Proposals was released in October 1990. Awards were made in September 1991. DESIGN NARRATIVE: Children were randomized to one of three treatment groups to receive either: inhaled albuterol alone, albuterol with inhaled budesonide, albuterol with nedocromil. Upon randomization, data were collected on demographic factors, physical and psychosocial development, clinical factors including medical history and extent of allergies, and quality of life factors including limitation of activity, absenteeism from school, emergency room visits, and hospitalizations. All subjects received a common educational program, differing only in the information presented regarding the medication used by the subjects. Each subject was given a standard protocol for dealing with asthma attacks. All subjects were treated and followed for five years with quarterly visits yearly. Recruitment began in July 1993 and ended in June 1995 with the accrual of 1,041 subjects. The study has been extended through June 2011 through three funding phases to observe the subjects but not provide asthma treatment. This will allow CAMP to (1.) determine the full impact of 4 to 6 years of anti-inflammatory therapy on attaining maximal lung function and final height; (2.) examine the natural history of asthma through age 26; and (3.) define patterns of reduced lung function growth and early decline of lung function in young adults.

NCT00000575
Sponsor principalJohns Hopkins Bloomberg School of Public Health
Dernière mise à jour : 3 avril 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

1041 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 5 à 12 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies bronchiquesHypersensibilitéHypersensibilité immédiateMaladies du Système ImmunitaireMaladies pulmonaires obstructivesHypersensibilité respiratoireMaladies des voies respiratoiresAsthmeMaladies pulmonaires

Critères

9 critères d'inclusion nécessaires pour participer
2 or more usages per week of an inhaled bronchodilator

Ability to comply with trial for 5 - 6.5 years

Age 5 to 12 years at time of screening

Asthma symptoms at least 2 times per week

Voir plus de critères

21 critères d'exclusion empêchent la participation
Any chronic condition presumed to interfere with the successful completion of the project or confound its interpretation

Any other active pulmonary disease

Current use of metoclopramide, ranitidine, or cimetidine

Demonstrated need for continuous use of glucocorticoids, either oral or inhaled

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

3 groupes d'intervention sont désignés dans cette étude

33,333% de chances d'être dans le groupe placebo en aveugle

Groupes de traitement

Groupe I

Comparateur actif
Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn

Groupe II

Comparateur actif
Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn

Groupe III

Placebo
Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
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TerminéAucun centre d'étude