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Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients (Sweapea)

11. oktober 2013 opdateret af: AstraZeneca

A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1144

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Brasilien
    • Brasil
      • Porto Alegre, Brasil, Brasilien
        • Research Site
    • ES
      • Vitoria, ES, Brasilien
        • Research Site
    • MG
      • Belo Horizonte, MG, Brasilien
        • Research Site
      • Juiz de Fora, MG, Brasilien
        • Research Site
    • RS
      • Porto Alegre, RS, Brasilien
        • Research Site
    • SP
      • Santo Andre, SP, Brasilien
        • Research Site
      • Sao Paulo, SP, Brasilien
        • Research Site
    • Santa Catarina
      • Florian Polis, Santa Catarina, Brasilien
        • Research Site
  • Den Russiske Føderation
      • Novosibirsk, Den Russiske Føderation
        • Research Site
      • Saint Petersburg, Den Russiske Føderation
        • Research Site
      • St. Petersburg, Den Russiske Føderation
        • Research Site
      • Vladikavkaz, Den Russiske Føderation
        • Research Site
    • Russia
      • Ekaterinburg, Russia, Den Russiske Føderation
        • Research Site
      • Moscow, Russia, Den Russiske Føderation
        • Research Site
  • Forenede Stater
    • California
      • Fullerton, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site
      • Mission Viejo, California, Forenede Stater
        • Research Site
      • Rolling Hills Estates, California, Forenede Stater
        • Research Site
      • San Diego, California, Forenede Stater
        • Research Site
      • San Jose, California, Forenede Stater
        • Research Site
    • Maryland
      • Wheaton, Maryland, Forenede Stater
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, Forenede Stater
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater
        • Research Site
    • Ohio
      • Sylvania, Ohio, Forenede Stater
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Research Site
    • Oregon
      • Medford, Oregon, Forenede Stater
        • Research Site
      • Portland, Oregon, Forenede Stater
        • Research Site
    • Pennsylvania
      • Collegeville, Pennsylvania, Forenede Stater
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
        • Research Site
      • Clinton, South Carolina, Forenede Stater
        • Research Site
    • Texas
      • Waco, Texas, Forenede Stater
        • Research Site
    • Washington
      • Tacoma, Washington, Forenede Stater
        • Research Site
  • Japan
      • Kochi, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Oita, Japan
        • Research Site
    • Fukuoka
      • Yanagawa, Fukuoka, Japan
        • Research Site
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Chitose, Hokkaido, Japan
        • Research Site
      • Kitahiroshima, Hokkaido, Japan
        • Research Site
      • Obihiro, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Himeji, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Naka-gun, Ibaraki, Japan
        • Research Site
    • Kagawa
      • Sakaide, Kagawa, Japan
        • Research Site
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Niigata
      • Nagaoka, Niigata, Japan
        • Research Site
    • Oita
      • Beppu, Oita, Japan
        • Research Site
    • Okayama
      • Kurashiki-shi, Okayama, Japan
        • Research Site
    • Shimane
      • Matsue, Shimane, Japan
        • Research Site
    • Tokyo
      • Chuo, Tokyo, Japan
        • Research Site
      • Chuo-ku, Tokyo, Japan
        • Research Site
      • Itabashi-ku, Tokyo, Japan
        • Research Site
      • Kodaira, Tokyo, Japan
        • Research Site
      • Nakano-ku, Tokyo, Japan
        • Research Site
      • Ohota-ku, Tokyo, Japan
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
    • Baja California
      • Tijuana, Baja California, Mexico
        • Research Site
    • D.f.
      • Mexico, D.f., Mexico
        • Research Site
    • Michoacan
      • Morelia, Michoacan, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Rumænien
      • Brasov, Rumænien
        • Research Site
      • Bucharest, Rumænien
        • Research Site
      • Bucuresti, Rumænien
        • Research Site
      • Cluj Napoca, Rumænien
        • Research Site
      • Constanta, Rumænien
        • Research Site
      • Iasi, Rumænien
        • Research Site
      • Tg. Mures, Rumænien
        • Research Site
  • Slovakiet
      • Banska Bystrica, Slovakiet
        • Research Site
      • Bardejov, Slovakiet
        • Research Site
      • Bratislava, Slovakiet
        • Research Site
      • Dunajska Streda, Slovakiet
        • Research Site
      • Hnusta, Slovakiet
        • Research Site
      • Komarno, Slovakiet
        • Research Site
      • Kosice, Slovakiet
        • Research Site
      • Levice, Slovakiet
        • Research Site
      • Liptovsky Hradok, Slovakiet
        • Research Site
      • Liptovsky Mikulas, Slovakiet
        • Research Site
      • Presov, Slovakiet
        • Research Site
      • Rimavska Sobota, Slovakiet
        • Research Site
      • Ruzomberok, Slovakiet
        • Research Site
      • Trencin, Slovakiet
        • Research Site
      • Zvolen, Slovakiet
        • Research Site
  • Sydafrika
      • Amanzimtoti, Sydafrika
        • Research Site
      • Cape Town, Sydafrika
        • Research Site
      • Durban, Sydafrika
        • Research Site
      • Durbanville, Sydafrika
        • Research Site
      • Pretoria, Sydafrika
        • Research Site
      • Umkomaas, Sydafrika
        • Research Site
    • Centurion
      • Lyttleton, Centurion, Sydafrika
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, Sydafrika
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Odesa, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Vinytsa, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
  • 6 months history of asthma according to ATS definition
  • Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
  • Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
  • A total ACQ5 score of 1.5 or more

Exclusion Criteria:

  • Respiratory infection significantly affecting the asthma
  • Any significant disease and disorder that may put the patient at risk or influence study results
  • Any clinically relevant abnormal findings
  • A smoking history of more than 10 pack years
  • Intake of oral, rectal or parenteral glucocorticosteroids

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Placebo to match AZD1981
Eksperimentel: AZD1981 10 mg
Medicin: AZD1981
AZD1981 twice daily
Medicin: AZD1981
AZD1981 once daily
Eksperimentel: AZD1981 40 mg
Medicin: AZD1981
AZD1981 twice daily
Medicin: AZD1981
AZD1981 once daily
Eksperimentel: AZD1981 100 mg
Medicin: AZD1981
AZD1981 twice daily
Medicin: AZD1981
AZD1981 once daily
Eksperimentel: AZD1981 400 mg
Medicin: AZD1981
AZD1981 twice daily
Medicin: AZD1981
AZD1981 once daily
Eksperimentel: AZD1981 80 mg
Medicin: AZD1981
AZD1981 twice daily
Medicin: AZD1981
AZD1981 once daily
Eksperimentel: AZD1981 200 mg
Medicin: AZD1981
AZD1981 twice daily
Medicin: AZD1981
AZD1981 once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pre-bronchodilator FEV1 at the Clinic
Tidsramme: Twelve week treatment period
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Twelve week treatment period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Morning and Evening PEF
Tidsramme: Twelve week treatment period
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Twelve week treatment period
Asthma Control Questionnaire 5-item (ACQ5)
Tidsramme: Twelve week treatment period
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Twelve week treatment period
Adverse Events
Tidsramme: Twelve week treatment period
Number of participants who had at least one adverse event during the randomized treatment period
Twelve week treatment period
Number of Participants With at Least One Severe Asthma Exacerbation
Tidsramme: Twelve week treatment period
Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
Twelve week treatment period
Number of Participants With at Least One Treatment Failure
Tidsramme: Twelve week treatment period
Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
Twelve week treatment period
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
Tidsramme: Twelve week treatment period
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.
Twelve week treatment period
Asthma Quality of Life Questionnaire (AQLQ(S))
Tidsramme: Twelve week treatment period
The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Twelve week treatment period
Asthma Symptom Score
Tidsramme: Twelve week treatment period
Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.
Twelve week treatment period
Total Reliever Medication Use
Tidsramme: Twelve week treatment period
Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.
Twelve week treatment period

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Chris O'Brien, MD, AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. oktober 2010

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

8. september 2010

Først indsendt, der opfyldte QC-kriterier

8. september 2010

Først opslået (Skøn)

9. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D9830C00008
  • 2010-020407-73 (EudraCT nummer)

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 Astmapatienter

Kliniske forsøg med AZD1981

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cyprus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner