Last updated: 11/04/2018 10:06:47

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

GSK study ID
OPL104226
Clinicaltrials.gov ID
NCT00259909
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A prospective observational study for the psychometric validation of a patient-reported questionnaire in acute exacerbations of chronic obstructive pulmonary disease (AECOPD)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline

Timeframe: Day 1

SGRQ Scores at exacerbation

Timeframe: Up to Day 14

SGRQ Scores post-exacerbation

Timeframe: Up to Day 14

Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline

Timeframe: Day 1

Acute SF-12v2 scores at exacerbation

Timeframe: Up to Day 14

Acute SF-12v2 scores post-exacerbation

Timeframe: Up to Day 14

Global Efficacy questionnaire scores at Baseline

Timeframe: Day 1

Global Efficacy questionnaire scores at exacerbation

Timeframe: Up to Day 14

Global Efficacy questionnaire scores post-exacerbation

Timeframe: Up to Day 14

Physician reported measures at Baseline

Timeframe: Day 1

Physician reported measures at exacerbation

Timeframe: Up to Day 14

Physician reported measures post-exacerbation

Timeframe: Up to Day 14

Secondary outcomes:

Change from Baseline in SGRQ-C Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in SGRQ-C scores

Timeframe: Up to Day 14

Change from Baseline in Acute SF-12v2 Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in Acute SF-12v2 scores

Timeframe: Up to Day 14

Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in Global Efficacy Questionnaire scores

Timeframe: Up to Day 14

Change from Baseline in GSK questionnaire Total and Subscales Scores

Timeframe: Up to Day 14

Percentage change in GSK questionnaire scores

Timeframe: Up to Day 14

Time to resolution of each domain score

Timeframe: Up to Day 35

Time to resolution of total domain score

Timeframe: Up to Day 35

Interventions:
  • Other: GSK questionnaire
  • Other: St. George's Respiratory Questionnaire
  • Other: Acute Short Form 12 version 2
  • Other: Global Efficacy questionnaire
    • Enrollment:
    259
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive, Infections, Bacterial
    Product
    SB742510
    Collaborators
    Not applicable
    Study date(s)
    November 2005 to November 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • 15 pack-year smoking history.
    • Confirmed diagnosis of COPD.
    • Clinical diagnosis of asthma.
    • Subjects not literate in the language of the questionnaire (e.g. US English).
    Inclusion and exclusion criteria
    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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13597
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10717
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St. Charles, Missouri, United States, 63301
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Genova, Liguria, Italy, 16132
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dueren, Nordrhein-Westfalen, Germany, 52349
    Status
    Study Complete
    Contact us
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    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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