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A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

29. oktober 2021 opdateret af: Amgen

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

315

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles, Belgien
        • Research Site
      • Leuven, Belgien
        • Research Site
      • Liege, Belgien
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • Research Site
      • Saint Petersburg, Den Russiske Føderation
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Jyväskylä, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Forenede Stater
    • California
      • Encinitas, California, Forenede Stater
        • Research Site
      • Huntington Beach, California, Forenede Stater
        • Research Site
      • Los Angeles, California, Forenede Stater
        • Research Site
      • San Diego, California, Forenede Stater
        • Research Site
      • Stockton, California, Forenede Stater
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater
        • Research Site
    • Georgia
      • Stockbridge, Georgia, Forenede Stater
        • Research Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, Forenede Stater
        • Research Site
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
        • Research Site
    • Montana
      • Bozeman, Montana, Forenede Stater
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater
        • Research Site
    • New Jersey
      • Skillman, New Jersey, Forenede Stater
        • Research Site
    • New York
      • Rockville Centre, New York, Forenede Stater
        • Research Site
    • North Carolina
      • High Point, North Carolina, Forenede Stater
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • Research Site
    • Oregon
      • Lake Oswego, Oregon, Forenede Stater
        • Research Site
      • Medford, Oregon, Forenede Stater
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Research Site
    • Texas
      • Dallas, Texas, Forenede Stater
        • Research Site
      • El Paso, Texas, Forenede Stater
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
        • Research Site
  • Holland
      • Rotterdam, Holland
        • Research Site
  • Korea, Republikken
      • Bucheon-si, Korea, Republikken
        • Research Site
      • Seoul, Korea, Republikken
        • Research Site
      • Suwon, Korea, Republikken
        • Research Site
  • Polen
      • Bialystok, Polen
        • Research Site
      • Chodziez, Polen
        • Research Site
      • Gdansk, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
  • Ungarn
      • Edeleny, Ungarn
        • Research Site
      • Matrahaza, Ungarn
        • Research Site
      • Tatabanya, Ungarn
        • Research Site
      • Torokbalint, Ungarn
        • Research Site
      • Zalaegerszeg - Pozva, Ungarn
        • Research Site
  • Østrig
      • Feldbach, Østrig
        • Research Site
      • Hallein, Østrig
        • Research Site
      • Wien, Østrig
        • 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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Men or women 18 to 65 years of age
  • Percent of predicted FEV1 ≥ 50% and ≤ 80%
  • At least 12% reversibility over pre-bronchodilator FEV1
  • Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
  • Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion Criteria:

  • Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
  • History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
  • Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver 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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Medicin: Placebo
SC injection.
Eksperimentel: AMG 827 140 mg
Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Medicin: AMG 827
SC injection.
Eksperimentel: AMG 827 210 mg
Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Medicin: AMG 827
SC injection.
Eksperimentel: AMG 827 280 mg
Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Medicin: AMG 827
SC injection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
Tidsramme: Baseline and Week 12

The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment.

It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1).

The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Baseline and Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Baseline and Week 12
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.
Baseline and Week 12
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
Tidsramme: Baseline and Week 12
Baseline and Week 12
Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
Tidsramme: Baseline to Week 12
Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.
Baseline to Week 12
Change From Baseline in Daily Asthma Symptom Score to Week 12
Tidsramme: Baseline and Week 12

Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation.

Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21).

Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Baseline and Week 12
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
Tidsramme: Baseline and Week 12

The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993).

Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score = mean of the responses to the 32 questions.

Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms.
Baseline and Week 12
Proportion of Asthma Symptom-free Days
Tidsramme: Up to Week 12

Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use.

The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks).
Up to Week 12
Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
Tidsramme: Week 8 (days 60 and 64), and pre-dose on Week 10
Week 8 (days 60 and 64), and pre-dose on Week 10
Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
Tidsramme: Week 8 (days 60 and 64), and pre-dose on Week 10
Week 8 (days 60 and 64), and pre-dose on Week 10
Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
Tidsramme: Week 8 (days 60 and 64), and pre-dose on Week 10
Week 8 (days 60 and 64), and pre-dose on Week 10

Samarbejdspartnere og efterforskere

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

Sponsor

Amgen

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

Hjælpsomme links

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 (Faktiske)

4. oktober 2010

Primær færdiggørelse (Faktiske)

21. december 2011

Studieafslutning (Faktiske)

21. december 2011

Datoer for studieregistrering

Først indsendt

5. august 2010

Først indsendt, der opfyldte QC-kriterier

9. september 2010

Først opslået (Skøn)

10. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20090203

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 .

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Sponsorer og samarbejdspartnere

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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