Study of MAP0010 in Asthmatic Children and Adolescents
A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
California
-
San Diego, California, Stati Uniti
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female asthmatic children/adolescents
- 1 to 18 years of age
- FEV1 greater than or equal to 50% predicted normal (where obtainable)
- Stable but symptomatic
- Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.
Exclusion Criteria:
- Any other significant childhood illness.
- Participated in any investigational clinical trial within the 30 days prior to screening.
- Use of any corticosteroid within 2 weeks of screening.
- Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
- Use of inhaled long acting bronchodilators.
- Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
- Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
- History suggestive (or diagnosis) of other concomitant lung disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
|
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
|
|
Sperimentale: MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
|
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
|
|
Comparatore placebo: Placebo
Placebo delivered by nebulization twice daily for 6 weeks
|
Placebo delivered by nebulization twice daily for 6 weeks
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Daytime Composite Symptom Score
Lasso di tempo: baseline, week 6
|
The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. |
baseline, week 6
|
|
Change From Baseline in Nighttime Composite Symptom Score
Lasso di tempo: baseline, week 6
|
The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. |
baseline, week 6
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in FEV1% Predicted
Lasso di tempo: baseline, week 6
|
The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second.
The percent predicted is calculated for age, gender, and height.
Subjects had to perform at least 3 acceptable maneuvers into a spirometer.
An increase indicates an improvement (a greater volume of air expired).
|
baseline, week 6
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Medical Director, MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MAP0010-CL-P201
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 .