- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00791518
Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy (LABD)
24 juillet 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
1084
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 25249
- GSK Investigational Site
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Arizona
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Tucson, Arizona, États-Unis, 85741
- GSK Investigational Site
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- GSK Investigational Site
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California
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National City, California, États-Unis, 91950
- GSK Investigational Site
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Rancho Mirage, California, États-Unis, 92270
- GSK Investigational Site
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Riverside, California, États-Unis, 92506
- GSK Investigational Site
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Santa Ana, California, États-Unis, 92704
- GSK Investigational Site
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Walnut Creek, California, États-Unis, 94598
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, États-Unis, 80907
- GSK Investigational Site
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Colorado Springs, Colorado, États-Unis, 80909
- GSK Investigational Site
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Connecticut
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Stamford, Connecticut, États-Unis, 06902
- GSK Investigational Site
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Florida
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Cocoa, Florida, États-Unis, 32927
- GSK Investigational Site
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DeLand, Florida, États-Unis, 32720
- GSK Investigational Site
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Largo, Florida, États-Unis, 33770
- GSK Investigational Site
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Miami, Florida, États-Unis, 33186
- GSK Investigational Site
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Miami, Florida, États-Unis, 33183
- GSK Investigational Site
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Naranja, Florida, États-Unis, 33032
- GSK Investigational Site
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South Miami, Florida, États-Unis, 33143
- GSK Investigational Site
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Tamarac, Florida, États-Unis, 33321
- GSK Investigational Site
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Tampa, Florida, États-Unis, 33613
- GSK Investigational Site
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Winter Park, Florida, États-Unis, 32789
- GSK Investigational Site
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Indiana
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Evansville, Indiana, États-Unis, 47711
- GSK Investigational Site
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Indianapolis, Indiana, États-Unis, 46229
- GSK Investigational Site
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Louisiana
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New Orleans, Louisiana, États-Unis, 70115
- GSK Investigational Site
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Sunset, Louisiana, États-Unis, 70584
- GSK Investigational Site
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Maine
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Biddeford, Maine, États-Unis, 04005
- GSK Investigational Site
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Minnesota
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Rochester, Minnesota, États-Unis, 55904
- GSK Investigational Site
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New York
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Albany, New York, États-Unis, 12205
- GSK Investigational Site
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North Carolina
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Mooresville, North Carolina, États-Unis, 28117
- GSK Investigational Site
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Raleigh, North Carolina, États-Unis, 27609
- GSK Investigational Site
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Salisbury, North Carolina, États-Unis, 28144
- GSK Investigational Site
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Wilmington, North Carolina, États-Unis, 28401
- GSK Investigational Site
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Winston-Salem, North Carolina, États-Unis, 27103
- GSK Investigational Site
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Ohio
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Canton, Ohio, États-Unis, 44718
- GSK Investigational Site
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Cincinnati, Ohio, États-Unis, 45231
- GSK Investigational Site
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Dayton, Ohio, États-Unis, 45439
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73120
- GSK Investigational Site
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Oklahoma City, Oklahoma, États-Unis, 73112
- GSK Investigational Site
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Oregon
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Portland, Oregon, États-Unis, 97213
- GSK Investigational Site
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Pennsylvania
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Clairton, Pennsylvania, États-Unis, 15205
- GSK Investigational Site
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Pittsburgh, Pennsylvania, États-Unis, 15243
- GSK Investigational Site
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South Carolina
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Anderson, South Carolina, États-Unis, 29621
- GSK Investigational Site
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Easley, South Carolina, États-Unis, 29650
- GSK Investigational Site
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Gaffney, South Carolina, États-Unis, 29340
- GSK Investigational Site
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Greenville, South Carolina, États-Unis, 29615
- GSK Investigational Site
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Mount Pleasant, South Carolina, États-Unis, 29464
- GSK Investigational Site
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Spartanburg, South Carolina, États-Unis, 29303
- GSK Investigational Site
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Union, South Carolina, États-Unis, 29379
- GSK Investigational Site
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Tennessee
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Johnson City, Tennessee, États-Unis, 37601
- GSK Investigational Site
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Milan, Tennessee, États-Unis, 38358
- GSK Investigational Site
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New Tazewell, Tennessee, États-Unis, 37824-1409
- GSK Investigational Site
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Texas
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Boerne, Texas, États-Unis, 78006
- GSK Investigational Site
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Houston, Texas, États-Unis, 77054
- GSK Investigational Site
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Killeen, Texas, États-Unis, 76542
- GSK Investigational Site
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Plano, Texas, États-Unis, 75024
- GSK Investigational Site
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Waco, Texas, États-Unis, 76712
- GSK Investigational Site
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Wichita Falls, Texas, États-Unis, 76309
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Patients with diagnosed COPD who are on only one long acting bronchodilator medication to control their COPD symptoms.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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No group
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Aucune intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
Délai: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
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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.
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Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal
Délai: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
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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.
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Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
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Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios
Délai: Day 1 of a 1-day study
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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).
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Day 1 of a 1-day study
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Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%
Délai: Day 1 of a 1-day study
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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).
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Day 1 of a 1-day study
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Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%
Délai: Day 1 of a 1-day study
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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).
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Day 1 of a 1-day study
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Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%
Délai: Day 1 of a 1-day study
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The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
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Day 1 of a 1-day study
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Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%
Délai: Day 1 of 1-day study
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The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
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Day 1 of 1-day study
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Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%
Délai: Day 1 of 1-day study
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The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
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Day 1 of 1-day study
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Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%
Délai: Day 1 of 1-day study
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The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
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Day 1 of 1-day study
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Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%
Délai: Day 1 of a 1-day study
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The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
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Day 1 of a 1-day study
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Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%
Délai: Day 1 of a 1-day study
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The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
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Day 1 of a 1-day study
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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
Délai: Day 1 of a 1-day study
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The number of participants with the indicated affected medical conditions were counted.
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Day 1 of a 1-day study
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2008
Achèvement primaire (Réel)
1 mai 2009
Achèvement de l'étude (Réel)
1 mai 2009
Dates d'inscription aux études
Première soumission
13 novembre 2008
Première soumission répondant aux critères de contrôle qualité
13 novembre 2008
Première publication (Estimation)
14 novembre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 juillet 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juillet 2014
Dernière vérification
1 octobre 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 111891
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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