Clinical trial NCT02302417: Study Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Asthma
Asthma-COPD Overlap Syndrome
Clinical Questionnaire
COPD
ACOS
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 1215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Summary of spirometry data: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)
timeFrame: Day 1
measure: Summary of spirometry data: Reversibility
timeFrame: Day 1
measure: Number of participants with response to Bronchodilators (Questionnaire Items 1 and 2)
timeFrame: Day 1
measure: Number of participants with disease progression (Questionnaire Item 3)
timeFrame: Day 1
measure: Number of participants with Variation in symptoms (Questionnaire Items 4-10)
timeFrame: Day 1
measure: Number of participants with atopic history (Questionnaire Items 11 and 12)
timeFrame: Day 1
measure: Number of participants with atopic history (Questionnaire Items 13-15)
timeFrame: Day 1
measure: Number of participants with vagal bias (Questionnaire Items 16 and 17)
timeFrame: Day 1
measure: Number of participants with burden of disease (Questionnaire Items 18-24)
timeFrame: Day 1
measure: Number of participants with symptom presentation (Questionnaire Items 25-34)
timeFrame: Day 1
measure: Number of participants with emotional response by Sex (Questionnaire Items 35 and 36)
timeFrame: Day 1
measure: Summary of age of onset (Questionnaire Items 37 and 38)
timeFrame: Day 1
measure: Number of participants with perception of respiratory disease (Questionnaire Items 39-40)
timeFrame: Day 1
measure: Number of participants with clinical features most helpful in diagnosis (Questionnaire Item 41)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Gaffney
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Union
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Morgantown
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: San Rafael
country: Argentina
facility: GSK Investigational Site
state: Mendoza
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Neu isenburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Teuchern
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Blagoveshchensk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: