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Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00259909

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-02

Study Completion Date

2006-11-07

Brief Summary

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The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient's perspective. At a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who experience acute exacerbations of their COPD.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Infections, Bacterial

Keywords

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Patient reported outcomes COPD acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with COPD

Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.

GSK questionnaire

Intervention Type OTHER

GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.

St. George's Respiratory Questionnaire

Intervention Type OTHER

The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.

Acute Short Form 12 version 2

Intervention Type OTHER

The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health

Global Efficacy questionnaire

Intervention Type OTHER

Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)

Interventions

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GSK questionnaire

GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.

Intervention Type OTHER

St. George's Respiratory Questionnaire

The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.

Intervention Type OTHER

Acute Short Form 12 version 2

The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health

Intervention Type OTHER

Global Efficacy questionnaire

Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 15 pack-year smoking history.
* Confirmed diagnosis of COPD.
* Have two documented episodes of acute exacerbation in past 12 months.

Exclusion Criteria

* Clinical diagnosis of asthma.
* Subjects not literate in the language of the questionnaire (e.g. US English).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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GSK Investigational Site

Birmingham, Alabama, United States

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GSK Investigational Site

Birmingham, Alabama, United States

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Hueytown, Alabama, United States

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Jasper, Alabama, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hartford, Connecticut, United States

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Hartford, Connecticut, United States

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Melbourne, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Hines, Illinois, United States

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North Chicago, Illinois, United States

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Peoria, Illinois, United States

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Springfield, Illinois, United States

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Newburgh, Indiana, United States

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South Bend, Indiana, United States

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Dubuque, Iowa, United States

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Waterloo, Iowa, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Lafayette, Louisiana, United States

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Sunset, Louisiana, United States

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Auburn, Maine, United States

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Towson, Maryland, United States

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Detroit, Michigan, United States

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DeWitt, Michigan, United States

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Plainwell, Michigan, United States

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Richland, Michigan, United States

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Saint Joseph, Michigan, United States

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Picayune, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Kirkwood, Missouri, United States

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Saint Charles, Missouri, United States

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Omaha, Nebraska, United States

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East Brunswick, New Jersey, United States

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Summit, New Jersey, United States

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Buffalo, New York, United States

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Great Neck, New York, United States

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Kingston, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Elizabeth City, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Allentown, Pennsylvania, United States

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Allentown, Pennsylvania, United States

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Audubon, Pennsylvania, United States

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King of Prussia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Plymouth Meeting, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Summerville, South Carolina, United States

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Clarksville, Tennessee, United States

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Morristown, Tennessee, United States

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Corsicana, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Lynchburg, Virginia, United States

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Richmond, Virginia, United States

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Schwetzingen, Baden-Wurttemberg, Germany

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Weinheim, Baden-Wurttemberg, Germany

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Bad Woerrishofen, Bavaria, Germany

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Kötzting, Bavaria, Germany

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Landsberg am Lech, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Potsdam, Brandenburg, Germany

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Rüdersdorf, Brandenburg, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Düren, North Rhine-Westphalia, Germany

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Euskirchen, North Rhine-Westphalia, Germany

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Gelsenkirchen, North Rhine-Westphalia, Germany

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Lüdenscheid, North Rhine-Westphalia, Germany

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Solingen, North Rhine-Westphalia, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Wahlstedt, Schleswig-Holstein, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Bari, Apulia, Italy

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Foggia, Apulia, Italy

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Caserta, Campania, Italy

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Eboli (SA), Campania, Italy

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Salerno, Campania, Italy

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Telese Terme (BN), Campania, Italy

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Genoa, Liguria, Italy

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Rozzano (MI), Lombardy, Italy

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Palermo, Sicily, Italy

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Pisa, Tuscany, Italy

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San Martino in Tregnano (Spoleto, PG), Umbria, Italy

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San Sisto (PG), Umbria, Italy

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Spoleto (PG), Umbria, Italy

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Cittadella (PD), Veneto, Italy

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Countries

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United States Germany Italy

Other Identifiers

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OPL104226

Identifier Type: -

Identifier Source: org_study_id