Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)

4. november 2010 opdateret af: AstraZeneca

A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Hvidovre, Danmark
        • Research Site
      • København Nv, Danmark
        • Research Site
      • Odense C, Danmark
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Preitilä, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • Holland
      • Breda, Holland
        • Research Site
      • Groningen, Holland
        • Research Site
  • Norge
      • Elverum, Norge
        • Research Site
      • Oslo, Norge
        • Research Site
      • Trondheim, Norge
        • Research Site
  • Sverige
      • Lund, Sverige
        • 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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of COPD, with symptoms for more than 1 year
  • Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
  • Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion Criteria:

  • Clinical suspicion of active tuberculosis
  • Any current clinically significant respiratory tract disorder other than COPD
  • History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina

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: 2
Placebo
Medicin: Placebo
Eksperimentel: 1
AZD4818
Medicin: AZD4818
Dry Powder, inhalation, b.i.d., 4 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Experiencing Adverse Events
Tidsramme: At all study visits
Number of patients who had an Adverse Event
At all study visits

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forced Expiratory Volume 1 (FEV1)
Tidsramme: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Change in (FEV1) from baseline to end of treatment
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Vital Capacity (FVC)
Tidsramme: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Change in FVC from baseline to end of treatment
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Vital Capacity (VC)
Tidsramme: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Change in VC from baseline to end of treatment
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Inspiratory Capacity (IC)
Tidsramme: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Change from IC baseline to end of treatment
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Expiratory Flow (FEF) 25%-75%
Tidsramme: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Change in FEF from baseline to end of treatment
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Tidsramme: Daily during run-in and treatment
Change from average during run-in to average during treatment
Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening
Tidsramme: Daily during run-in and treatment
Change in PEF from average during run-in to average during treatment
Daily during run-in and treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
Tidsramme: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Tidsramme: Daily during run-in and treatment
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Tidsramme: Daily during run-in and treatment
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Tidsramme: Daily during run-in and treatment
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Tidsramme: Daily during run-in and treatment
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Daily during run-in and treatment
6-minute Walk Test
Tidsramme: Before treatment and after 4 weeks of treatment
Change from baseline to end of treatment
Before treatment and after 4 weeks of treatment

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: Huib AM Kerstjens, MD, PhD, University Medical Centre, Groningen, The Netherlands

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. januar 2008

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. august 2008

Datoer for studieregistrering

Først indsendt

25. februar 2008

Først indsendt, der opfyldte QC-kriterier

25. februar 2008

Først opslået (Skøn)

5. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. december 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2010

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D3540C00005

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner