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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: ACOS clinical questionnaire; Procedure: Spirometry

Study type: Interventional

Funder types: Industry

Identifiers

NCT02302417

201703

Details and patient eligibility

About

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.

Enrollment: 1,215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,215 participants in 1 patient group

All Subjects

Other group

Description:

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.

Treatment:

Procedure: Spirometry

Other: ACOS clinical questionnaire