- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00257933
Oral Prednisolone Dosing in Children Hospitalized With Asthma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Practice guidelines for the management of asthma in children universally recommend systemic corticosteroids for the treatment of moderate to severe asthma exacerbations. However, these guidelines vary widely with respect to dose, frequency, method of delivery, and duration of therapy. In actual practice, there is also considerable variation among clinicians in terms of corticosteroid dosing in children hospitalized with asthma exacerbations. At the Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of 4.0 mg/kg/day (1.0 mg/kg every 6 hours to a maximum of 30 mg/dose) although many other pediatric hospitals use a 2.0 mg/kg/day dose (1.0 mg/kg every 12 hours to a maximum of 30 mg/dose). Systematic reviews of the literature have called for a clinical trial to evaluate the effect of different doses of corticosteroids in treating pediatric asthma patients hospitalized with exacerbations.
This study will use a randomized, double-blind, controlled trial design in order to compare the efficacy of two different steroid doses in resolving acute exacerbations of asthma in hospitalized children. Children being hospitalized for asthma exacerbations from the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive prednisolone either in the higher dose (1.0 mg/kg (max 30 mg) every 6 hours), or the lower dose (1.0 mg/kg (max 30 mg) every 12 hours and placebo doses at 6 hour intervals in between) for the first 48 hours of hospitalization. Once 48 hours has past, all patients still hospitalized will receive 1.0 mg/kg (max 30 mg) every 12 hours for the duration of hospitalization. Approximately 156 patients with 78 in each arm of the study will be enrolled. This study should be completed in six to eight months. A non-inferiority study design will be used. The primary outcome will be duration of hospitalization, as determined by duration of time elapsed from first dose of prednisolone administered in the emergency department (ED) until the discharge dose of albuterol is administered. Secondary outcomes will include time elapsed from the time the admission order is written until the discharge order is written, time spent in each severity level of the asthma care pathway, degree and rate of improvement in forced expiratory volume in one second (FEV1), improvement in peak expiratory flows (PEF), improvement in asthma symptom scores, and rate of relapse after discharge.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- The Children's Hospital of Philadelphia
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Physician-diagnosed asthma with at least two previous visits to ED or primary care provider for asthma care
- Clinical decision by ED attending physician to admit to Acute Care Unit (ACU) after standardized initial ED treatment
Exclusion Criteria:
- Clinical decision to begin continuous intravenous beta-agonist infusion
- Clinical decision to begin intravenous methylprednisolone therapy
- Clinical decision to admit to the Pediatric Intensive Care Unit
- Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
- Any contraindication to corticosteroid administration
- Any systemic corticosteroid treatment within two weeks of presenting to the ED
- Potential subjects will be excluded if informed consent is not obtained
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 1
High dose prednisolone
|
4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
Altri nomi:
|
Sperimentale: 2
Lower dose prednisolone alternating with placebo
|
2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered
Lasso di tempo: Median time from loading dose to home dose of albuterol
|
Median time from loading dose to home dose of albuterol
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order
Lasso di tempo: Mean time from writing admit order until discharge order
|
Mean time from writing admit order until discharge order
|
Time Spent in Each Severity Level of the Asthma Care Pathway
Lasso di tempo: Time spent in each severity level of pathway
|
Time spent in each severity level of pathway
|
The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups
Lasso di tempo: Every 4 hours during hospitalization
|
Every 4 hours during hospitalization
|
Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups
Lasso di tempo: Every 4 hours during hospitalization
|
Every 4 hours during hospitalization
|
Rate of Relapse Between Treatment Groups
Lasso di tempo: 2 weeks after hospitalization
|
2 weeks after hospitalization
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Joseph J Zorc, MD, Children's Hospital of Philadelphia
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie del sistema immunitario
- Malattie polmonari
- Ipersensibilità, immediata
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità
- Asma
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti antineoplastici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Agenti neuroprotettivi
- Agenti protettivi
- Prednisolone
- Acetato di metilprednisolone
- Metilprednisolone
- Metilprednisolone emisuccinato
- Prednisolone acetato
- Prednisolone emisuccinato
- Prednisolone fosfato
Altri numeri di identificazione dello studio
- 2005-9-4377
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Prednisolone high dose
-
Sanofi Pasteur, a Sanofi CompanyCompletato
-
Arizona State UniversityNational Institute of Mental Health (NIMH)CompletatoDepressione | Disturbo della condottaStati Uniti
-
University of Alabama at BirminghamNon ancora reclutamentoTerapia medica nutrizionale ed educazione all'autogestione del diabete per le persone con disabilitàDiabete di tipo 2 | Disabilità fisica
-
Zimmer BiometCompletatoOsteoartrite | Artrite reumatoide | Artrite traumaticaCorea, Repubblica di
-
Barnes-Jewish HospitalCompletato
-
Ohio State UniversityCompletatoAmbulatoriale | Relazioni medico-paziente | Diagnosi delle strutture ospedaliere | Fascicolo Sanitario ElettronicoStati Uniti
-
Ewha Womans UniversityCompletatoFemmina | Artrosi del ginocchioCorea, Repubblica di
-
University of PittsburghPatient-Centered Outcomes Research InstituteAttivo, non reclutanteDepressione | Ipertensione | Diabete | Artrite | Schizofrenia | Broncopneumopatia cronica ostruttiva | Fibrillazione atriale | Asma | Ansia | Disordine bipolare | Insufficienza cardiaca congestiziaStati Uniti
-
Duke UniversityVanderbilt UniversityCompletatoAllenamento ad intervalli ad alta intensità | Malattia critica | Covid19 | Tracker per il fitness | Terapia intensiva | Unità di Terapia IntensivaStati Uniti
-
Fudan UniversityReclutamentoBambino | Funzione cardiopolmonareCina