- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00301171
Treatment of Persistent Wheezing in Infants and Children
Respiratory Function in Infants With Persistent Wheezing
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Asthma prevalence has steadily increased in the United States since the early 1980s, with infants and young children showing the largest increase. Some young children experience wheezing, but it is not known if this is related specifically to asthma. Wheezing may be caused by a respiratory syncytial virus, maternal smoking, a family history of asthma, or allergies. In addition, some infants who experience wheezing may have small or dysfunctional airways and may not respond well to commonly prescribed anti-inflammatory medications. Because of the many causes of wheezing, in order to prescribe the most effective treatment, it is necessary to thoroughly assess lung function, allergic sensitization, and airway inflammation. The purpose of this study is to examine the causes of moderate to severe wheezing in infants and assess the infants' response to inhaled corticosteroid therapy. The study will also assess new and safer ways to measure lung function and airway inflammation.
This study will enroll infants with moderate to severe persistent wheezing. At study entry, participants will undergo lung function testing, which will include a spirometry test, measures of lung volumes, and assessment of bronchodilator responsiveness. Exhaled breath condensate and blood will be collected, and skin-prick testing will be performed to test for allergies. Participants will then be randomly assigned to receive either fluticasone, an inhaled steroid, or placebo for one month. At the end of the month, lung function testing will be performed and exhaled breath and serum measures will be collected to assess airway inflammation. Participants will attend a follow-up evaluation at age 5 years. During the evaluation, lung function, exhaled breath condensate, and serum markers of inflammation will be measured again, and skin-prick testing will also be performed again.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Moderate to severe persistent wheezing, as defined by the National Asthma Education and Prevention Program Expert Panel Report 2
- No signs of upper or lower respiratory tract infection for at least two weeks prior to study entry
Exclusion Criteria:
- Received therapy with inhaled corticosteroids in the month prior to study entry
- History of seizures or other neurologic disorders
- Hypoxemia requiring supplemental oxygen to maintain oxygen saturation above 90%
- Sepsis
- Underwent a tracheostomy
- Heart disease
- Suspected or documented pulmonary hypertension
- Currently undergoing assisted ventilation
- Born at less than 36 weeks gestation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Change in FEF75 levels
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Change in RV/TLC ratio
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Loss of bronchodilator responsiveness (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
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Mesures de résultats secondaires
Mesure des résultats |
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Change in asthma symptom scores (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Amy G. Filbrun, MD, University of Michigan
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Signes et symptômes respiratoires
- Sons respiratoires
- Effets physiologiques des médicaments
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Agents dermatologiques
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Agents anti-allergiques
- Fluticasone
Autres numéros d'identification d'étude
- 370
- K23HL067881-04 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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