Last updated: 11/03/2018 21:50:29

Study assessing utility of a clinical questionnaire to identify subjects with features of both Asthma and Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
201703
Clinicaltrials.gov ID
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: The Utility of a Clinical Questionnaire to Identify Subjects with Features of Both Asthma and COPD
Trial description: The primary objective of the study is to identify demographic and non-spirometric clinical features predictive of the asthma-COPD overlap population. The study aims to explore and identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient’s clinical profile that enable clinical differentiation from subjects with a primary diagnosis of either asthma alone (without persistent obstruction) or COPD alone (without reversibility). The study is designed as a targeted medical history survey which consists of a 41-item questionnaire, which will be administered by a qualified health care practitioner at the time a subject’s medical history is taken. The questionnaire has been developed to elicit specific details of the respiratory history, including the following: bronchodilator use, disease progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of disease, symptom presentation, co morbidities and age of onset. In addition, demographic information, standard medical history, co morbidity and spirometric results will also be obtained and analyzed in conjunction with the questionnaire results. Approximately 1000 subjects are required for the study.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Summary of spirometry data: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)

Timeframe: Day 1

Summary of spirometry data: Reversibility

Timeframe: Day 1

Number of participants with response to Bronchodilators (Questionnaire Items 1 and 2)

Timeframe: Day 1

Number of participants with disease progression (Questionnaire Item 3)

Timeframe: Day 1

Number of participants with Variation in symptoms (Questionnaire Items 4-10)

Timeframe: Day 1

Number of participants with atopic history (Questionnaire Items 11 and 12)

Timeframe: Day 1

Number of participants with atopic history (Questionnaire Items 13-15)

Timeframe: Day 1

Number of participants with vagal bias (Questionnaire Items 16 and 17)

Timeframe: Day 1

Number of participants with burden of disease (Questionnaire Items 18-24)

Timeframe: Day 1

Number of participants with symptom presentation (Questionnaire Items 25-34)

Timeframe: Day 1

Number of participants with emotional response by Sex (Questionnaire Items 35 and 36)

Timeframe: Day 1

Summary of age of onset (Questionnaire Items 37 and 38)

Timeframe: Day 1

Number of participants with perception of respiratory disease (Questionnaire Items 39-40)

Timeframe: Day 1

Number of participants with clinical features most helpful in diagnosis (Questionnaire Item 41)

Timeframe: Day 1

Secondary outcomes:
Not applicable
Interventions:
  • Procedure/surgery: Spirometry
  • Other: ACOS clinical questionnaire
  • Enrollment:
    1215
    Primary completion date:
    2015-28-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, fluticasone furoate/umeclidinium bromide, umeclidinium bromide
    Collaborators
    Not applicable
    Study date(s)
    January 2015 to May 2015
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Subject must be 18 years of age or older.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Frankfurt, Hessen, Germany, 60596
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dnipropetrovsk, Ukraine, 49006
    Status
    Study Complete
    Location
    GSK Investigational Site
    Leipzg, Sachsen, Germany, 04109
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45231
    Status
    Study Complete
    Location
    GSK Investigational Site
    Neu isenburg, Hessen, Germany, 63263
    Status
    Study Complete
    Location
    GSK Investigational Site
    Union, South Carolina, United States, 29379
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English
    Protocol
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-28-05
    Actual study completion date
    2015-28-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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