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

Completed · Phase 2

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT02302417

Run by

GlaxoSmithKline

People needed

1215

Starts

2015-01-01

Expected to finish

2015-05-28

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Morgantown, West Virginia, United States
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — San Rafael, Mendoza Province, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Tucumán Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Mendoza, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Neu-Isenburg, Hesse, Germany
• GSK Investigational Site — Hanover, Lower Saxony, Germany
• GSK Investigational Site — Leipzg, Saxony, Germany
• GSK Investigational Site — Teuchern, Saxony-Anhalt, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Blagoveshchensk, Russia
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Nizhny Novgorod, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Saratov, Russia

Full record on ClinicalTrials.gov

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