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Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy (LABD)

24 juli 2014 uppdaterad av: GlaxoSmithKline

An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

1084

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 25249
        • GSK Investigational Site
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85741
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • GSK Investigational Site
    • California
      • National City, California, Förenta staterna, 91950
        • GSK Investigational Site
      • Rancho Mirage, California, Förenta staterna, 92270
        • GSK Investigational Site
      • Riverside, California, Förenta staterna, 92506
        • GSK Investigational Site
      • Santa Ana, California, Förenta staterna, 92704
        • GSK Investigational Site
      • Walnut Creek, California, Förenta staterna, 94598
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna, 80907
        • GSK Investigational Site
      • Colorado Springs, Colorado, Förenta staterna, 80909
        • GSK Investigational Site
    • Connecticut
      • Stamford, Connecticut, Förenta staterna, 06902
        • GSK Investigational Site
    • Florida
      • Cocoa, Florida, Förenta staterna, 32927
        • GSK Investigational Site
      • DeLand, Florida, Förenta staterna, 32720
        • GSK Investigational Site
      • Largo, Florida, Förenta staterna, 33770
        • GSK Investigational Site
      • Miami, Florida, Förenta staterna, 33186
        • GSK Investigational Site
      • Miami, Florida, Förenta staterna, 33183
        • GSK Investigational Site
      • Naranja, Florida, Förenta staterna, 33032
        • GSK Investigational Site
      • South Miami, Florida, Förenta staterna, 33143
        • GSK Investigational Site
      • Tamarac, Florida, Förenta staterna, 33321
        • GSK Investigational Site
      • Tampa, Florida, Förenta staterna, 33613
        • GSK Investigational Site
      • Winter Park, Florida, Förenta staterna, 32789
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, Förenta staterna, 47711
        • GSK Investigational Site
      • Indianapolis, Indiana, Förenta staterna, 46229
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70115
        • GSK Investigational Site
      • Sunset, Louisiana, Förenta staterna, 70584
        • GSK Investigational Site
    • Maine
      • Biddeford, Maine, Förenta staterna, 04005
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55904
        • GSK Investigational Site
    • New York
      • Albany, New York, Förenta staterna, 12205
        • GSK Investigational Site
    • North Carolina
      • Mooresville, North Carolina, Förenta staterna, 28117
        • GSK Investigational Site
      • Raleigh, North Carolina, Förenta staterna, 27609
        • GSK Investigational Site
      • Salisbury, North Carolina, Förenta staterna, 28144
        • GSK Investigational Site
      • Wilmington, North Carolina, Förenta staterna, 28401
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, Förenta staterna, 44718
        • GSK Investigational Site
      • Cincinnati, Ohio, Förenta staterna, 45231
        • GSK Investigational Site
      • Dayton, Ohio, Förenta staterna, 45439
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73120
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, Förenta staterna, 73112
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Förenta staterna, 97213
        • GSK Investigational Site
    • Pennsylvania
      • Clairton, Pennsylvania, Förenta staterna, 15205
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Förenta staterna, 15243
        • GSK Investigational Site
    • South Carolina
      • Anderson, South Carolina, Förenta staterna, 29621
        • GSK Investigational Site
      • Easley, South Carolina, Förenta staterna, 29650
        • GSK Investigational Site
      • Gaffney, South Carolina, Förenta staterna, 29340
        • GSK Investigational Site
      • Greenville, South Carolina, Förenta staterna, 29615
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, Förenta staterna, 29464
        • GSK Investigational Site
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • GSK Investigational Site
      • Union, South Carolina, Förenta staterna, 29379
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, Förenta staterna, 37601
        • GSK Investigational Site
      • Milan, Tennessee, Förenta staterna, 38358
        • GSK Investigational Site
      • New Tazewell, Tennessee, Förenta staterna, 37824-1409
        • GSK Investigational Site
    • Texas
      • Boerne, Texas, Förenta staterna, 78006
        • GSK Investigational Site
      • Houston, Texas, Förenta staterna, 77054
        • GSK Investigational Site
      • Killeen, Texas, Förenta staterna, 76542
        • GSK Investigational Site
      • Plano, Texas, Förenta staterna, 75024
        • GSK Investigational Site
      • Waco, Texas, Förenta staterna, 76712
        • GSK Investigational Site
      • Wichita Falls, Texas, Förenta staterna, 76309
        • GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Patients with diagnosed COPD who are on only one long acting bronchodilator medication to control their COPD symptoms.

Beskrivning

Inclusion Criteria:

  • Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)
  • Established history of COPD as diagnosed by a physician
  • Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit
  • Ability to read, comprehend, and record information in the English language

Exclusion Criteria:

  • Currently active asthma (receiving asthma therapy and or having asthma symptoms)
  • Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
  • Previous lung surgery
  • Other respiratory disorders other than COPD
  • Current alcohol, illegal drug, or solvent abuse
  • Females with a positive urine pregnancy test at the study visit

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
No group
Läkemedel: Inget ingripande
Inget ingripande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
Tidsram: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.
Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal
Tidsram: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.
Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios
Tidsram: Day 1 of a 1-day study
The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).
Day 1 of a 1-day study
Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%
Tidsram: Day 1 of a 1-day study
The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).
Day 1 of a 1-day study
Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%
Tidsram: Day 1 of a 1-day study
The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).
Day 1 of a 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%
Tidsram: Day 1 of a 1-day study
The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
Day 1 of a 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%
Tidsram: Day 1 of 1-day study
The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
Day 1 of 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%
Tidsram: Day 1 of 1-day study
The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
Day 1 of 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%
Tidsram: Day 1 of 1-day study
The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
Day 1 of 1-day study
Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%
Tidsram: Day 1 of a 1-day study
The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
Day 1 of a 1-day study
Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%
Tidsram: Day 1 of a 1-day study
The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
Day 1 of a 1-day study
Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups
Tidsram: Day 1 of a 1-day study
The number of participants with the indicated affected medical conditions were counted.
Day 1 of a 1-day study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2008

Primärt slutförande (Faktisk)

1 maj 2009

Avslutad studie (Faktisk)

1 maj 2009

Studieregistreringsdatum

Först inskickad

13 november 2008

Först inskickad som uppfyllde QC-kriterierna

13 november 2008

Första postat (Uppskatta)

14 november 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 juli 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2014

Senast verifierad

1 oktober 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 111891

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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