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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2015-28-05
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
Location
GSK Investigational Site
Medford, Oregon, United States, 97504
Status
Study Complete
Location
GSK Investigational Site
Saint-Petersburg, Russia, 194354
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10117
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Blagoveshchensk, Russia, 675000
Status
Study Complete
Location
GSK Investigational Site
Mendoza, Argentina, 5500
Status
Study Complete
Location
GSK Investigational Site
Moscow, Russia, 115409
Status
Study Complete
Location
GSK Investigational Site
San Rafael, Mendoza, Argentina, 5600
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Tucumán, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DBS
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000IFL
Status
Study Complete
Location
GSK Investigational Site
Saratov, Russia, 410028
Status
Study Complete
Location
GSK Investigational Site
Nizhniy Novgorod, Russia, 603126
Status
Study Complete
Location
GSK Investigational Site
Kyiv, Ukraine, 3680
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10119
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Russia, 198216
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1028AAP
Status
Study Complete
Location
GSK Investigational Site
Kharkiv, Ukraine, 61124
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
Saint-Petersburg, Russia, 194356
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Teuchern, Sachsen-Anhalt, Germany, 06682
Status
Study Complete

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
Completed
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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