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

A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

12. maj 2017 opdateret af: Genentech, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease

This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Childrens Hospital of LA
      • Los Angeles, California, Forenede Stater, 90033
        • USC Adult CF Center
      • Orange, California, Forenede Stater, 92868
        • CHOC
      • Sacramento, California, Forenede Stater, 95819
        • Capital Allergy Resp Dis Ctr
      • Ventura, California, Forenede Stater, 93003
        • Ventura County Medical Ctr
    • Colorado
      • Denver, Colorado, Forenede Stater, 80206
        • Nat'l Jewish Med/Research Ctr
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32204
        • Pulm & Critical Care Assoc
      • Miami, Florida, Forenede Stater, 33136
        • Univ of Miami
      • Orlando, Florida, Forenede Stater, 32803
        • Central Florida Pulmonary Grou
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Brown Univ School of Medicine
      • Augusta, Georgia, Forenede Stater, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Univ of Kentucky Med Ctr
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-5212
        • Univ of Michigan Hlth System
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • Michigan State University
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Univ of Minnesota Dept of Derm
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Pulmonary & Critical Care Med
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89107
        • Children's Lung Specialist
    • New Jersey
      • Long Branch, New Jersey, Forenede Stater, 07740
        • Monmouth Medical Center
      • Morristown, New Jersey, Forenede Stater, 07962
        • Morristown Memorial Hospital
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • St. Peters Univ Hospital
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-0001
        • University of New Mexico
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Medical College
      • New Hyde Park, New York, Forenede Stater, 11040
        • Long Island Jew Adult CF Ctr
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical Univ
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Pediatric Clinical
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rainbow Babies & Child Hosp
      • Toledo, Ohio, Forenede Stater, 43606
        • Toledo Childrens Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Santiago Reyes MD-Private Prac
      • Tulsa, Oklahoma, Forenede Stater, 74145
        • CF Solutions, Inc
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15260
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical Univ of South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Pediatric Pulmonary Assoc
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, Forenede Stater, 78212
        • Alamo Clinical Research Assoc
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • W Virginia Univ Health Sci Ctr

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

14 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Signed Informed Consent Form and, if applicable, Assent Form
  • Age ≥ 14 years old at screening
  • Proven diagnosis of CF
  • Ability to perform acceptable and reproducible spirometry maneuvers at screening
  • FVC ≤ 45% predicted for race, height, age, and sex at screening
  • Chronic use of Pulmozyme for at least 3 months in the last year and daily or twice daily use during the 14 days prior to screening
  • Stable regimen of chest physiotherapy (CPT) for at least 14 days prior to screening
  • Ability to complete the 6-minute walk test at screening
  • Ability to complete the 6-minute walk test and spirometry at Visit 2
  • If on routine tobramycin solution for inhalation (i.e., TOBI®) or other cycled antibiotic therapy, intention to either start or stop therapy at the time of Visit 2 (based on routine therapy cycle; no other planned change in this antibiotic regimen for 28 days before or 28 days after Visit 2)
  • Clinically stable with no change in medications during the 14 days prior to screening

Exclusion Criteria:

  • Use of an investigational drug or device within 28 days prior to screening
  • Previous episode of acute respiratory failure requiring assisted ventilation within 2 years prior to screening
  • Previous lung transplant
  • Any cardiac disease that would contraindicate performing the 6-minute walk test
  • Pregnancy or nursing
  • Known hypersensitivity or other contraindication to the use of Pulmozyme
  • Previous completion or premature discontinuation of study drug or withdrawal from this study
  • More than one prior screening failure for this study at any time or any prior screening failure for this study within the last 28 days

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
Medicin: placebo
2.5 mg inhalation dose twice daily for 14±2 days
Eksperimentel: Dornase alfa
Medicin: Dornase alfa
2.5 mg inhalation dose twice daily for 14±2 days
Andre navne:
  • Pulmozyme

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Distance Walked in the 6-minute Walk Test
Tidsramme: From baseline to Day 14
Change in distance walked was defined as (distance walked in 6 minutes at baseline [Day 0]) - (distance walked in 6 minutes at Day 14) in meters.
From baseline to Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pulmonary Function as Measured by FEV1 and FVC
Tidsramme: From baseline to Day 14
FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) were recorded at Day 0 (baseline) and Day 14. Change in FEV1 and FVC from baseline to Day 14 was reported as a percentage of values predicted for age, height, and race.
From baseline to Day 14

Samarbejdspartnere og efterforskere

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

Sponsor

Genentech, Inc.

Efterforskere

  • Studieleder: Michelle Freemer, M.D., Genentech, Inc.

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. marts 2007

Primær færdiggørelse (Faktiske)

1. november 2008

Studieafslutning (Faktiske)

1. november 2008

Datoer for studieregistrering

Først indsendt

11. februar 2007

Først indsendt, der opfyldte QC-kriterier

11. februar 2007

Først opslået (Skøn)

13. februar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Z3877g

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 Ethiopia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner