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

Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

27. november 2013 opdateret af: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)

Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

126

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Kingston, Ontario, Canada
        • 205.440.2003 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 205.440.2001 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 205.440.2004 Boehringer Ingelheim Investigational Site
      • Ste-Foy, Quebec, Canada
        • 205.440.2002 Boehringer Ingelheim Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • 205.440.1006 Boehringer Ingelheim Investigational Site
      • Jasper, Alabama, Forenede Stater
        • 205.440.1015 Boehringer Ingelheim Investigational Site
    • California
      • Torrance, California, Forenede Stater
        • 205.440.1002 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, Forenede Stater
        • 205.440.1018 Boehringer Ingelheim Investigational Site
    • Illinois
      • Springfield, Illinois, Forenede Stater
        • 205.440.1008 Boehringer Ingelheim Investigational Site
    • Indiana
      • Muncie, Indiana, Forenede Stater
        • 205.440.1017 Boehringer Ingelheim Investigational Site
    • Michigan
      • Livonia, Michigan, Forenede Stater
        • 205.440.1020 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater
        • 205.440.1011 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • 205.440.1019 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater
        • 205.440.1013 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater
        • 205.440.1007 Boehringer Ingelheim Investigational 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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.

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: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 18 mcg tiotropium
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Medicin: Tiotropium
double blind randomized crossover
Placebo komparator: Placebo
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Medicin: Placebo
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
Ingen indgriben: Control
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Inspiratory Capacity (IC) at Isotime
Tidsramme: baseline, six weeks of treatment
Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.
baseline, six weeks of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Constant Work Rate (CWR) Endurance Time
Tidsramme: six weeks of treatment
CWR exercise duration calculated as the length of time of the exercise period
six weeks of treatment
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Tidsramme: baseline, six weeks of treatment
Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).
baseline, six weeks of treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

Samarbejdspartnere

Pfizer

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

1. februar 2010

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

19. februar 2010

Først indsendt, der opfyldte QC-kriterier

19. februar 2010

Først opslået (Skøn)

22. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. november 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 205.440

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 Tiotropium

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saint Lucia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner