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Study Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT02302417

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2015-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All Subjects

Approximately 1000 subjects with clinical diagnoses of asthma and/or COPD or clinical presentations suggestive of either or both will be included. Subjects will undergo spirometry assessments and also will be asked a series of questions by a qualified health care practitioner using a questionnaire containing 41 questions concerning their respiratory condition.

Group Type OTHER

Spirometry

Intervention Type PROCEDURE

Classification of respiratory diseases by Spirometry will be performed to differentiate subjects between Asthma only, ACOS, and COPD only. Spirometry obtained from measurements in the past 6 months is acceptable for purposes of this study. For subjects without spirometry in the past 6 months, spirometry will be performed to obtain pre- and post-bronchodilator Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and reversibility

ACOS clinical questionnaire

Intervention Type OTHER

The 41-question questionnaire includes questions concerning the following: a) response to bronchodilator, b) disease progression, c) variations in symptom, d) atopic history, e) symptom triggers, f) vagal bias, g) burden of disease, h) symptom presentation, i) emotional aspects, and j) age of onset. In addition, two questions will capture patient perception of his/her respiratory disease and the physician's diagnosis

Interventions

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Spirometry

Classification of respiratory diseases by Spirometry will be performed to differentiate subjects between Asthma only, ACOS, and COPD only. Spirometry obtained from measurements in the past 6 months is acceptable for purposes of this study. For subjects without spirometry in the past 6 months, spirometry will be performed to obtain pre- and post-bronchodilator Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and reversibility

Intervention Type PROCEDURE

ACOS clinical questionnaire

The 41-question questionnaire includes questions concerning the following: a) response to bronchodilator, b) disease progression, c) variations in symptom, d) atopic history, e) symptom triggers, f) vagal bias, g) burden of disease, h) symptom presentation, i) emotional aspects, and j) age of onset. In addition, two questions will capture patient perception of his/her respiratory disease and the physician's diagnosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Newport Beach, California, United States

Site Status

GSK Investigational Site

Upland, California, United States

Site Status

GSK Investigational Site

Sunset, Louisiana, United States

Site Status

GSK Investigational Site

Charlotte, North Carolina, United States

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GSK Investigational Site

Cincinnati, Ohio, United States

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GSK Investigational Site

Medford, Oregon, United States

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GSK Investigational Site

Gaffney, South Carolina, United States

Site Status

GSK Investigational Site

Greenville, South Carolina, United States

Site Status

GSK Investigational Site

Rock Hill, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Union, South Carolina, United States

Site Status

GSK Investigational Site

Morgantown, West Virginia, United States

Site Status

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

San Rafael, Mendoza Province, Argentina

Site Status

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, , Argentina

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Leipzg, Saxony, Germany

Site Status

GSK Investigational Site

Teuchern, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Blagoveshchensk, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Nizhny Novgorod, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saratov, , Russia

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

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GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

Countries

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United States Argentina Germany Russia Ukraine

Other Identifiers

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201703

Identifier Type: -

Identifier Source: org_study_id

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