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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)

NCT02302417 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1215

Last updated 2017-09-11

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

PROCEDURE

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

OTHER

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2015-05-01
Completion
2015-05-28

Countries

  • United States
  • Argentina
  • Germany
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302417 on ClinicalTrials.gov