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Study of MAP0010 in Asthmatic Children and Adolescents

9. december 2013 opdateret af: Allergan

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

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

208

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
Medicin: MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
Eksperimentel: MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Medicin: MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Placebo komparator: Placebo
Placebo delivered by nebulization twice daily for 6 weeks
Medicin: Placebo
Placebo delivered by nebulization twice daily for 6 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Daytime Composite Symptom Score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in FEV1% Predicted
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Allergan

Samarbejdspartnere

MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Efterforskere

  • Studieleder: Medical Director, MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2006

Primær færdiggørelse (Faktiske)

1. december 2006

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

12. juni 2008

Først indsendt, der opfyldte QC-kriterier

13. juni 2008

Først opslået (Skøn)

16. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MAP0010-CL-P201

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med MAP0010 low dose

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Paraguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner