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)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
1215
Primary completion date:
2015-28-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
- Inclusion Criteria:
- Subject must be 18 years of age or older.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Subject must be 18 years of age or older.
- Subject has been diagnosed as having asthma and/or COPD.
- Informed consent is required for independent sites initiating this protocol
Trial location(s)
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Showing 1 - 6 of 37 Results
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website