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Identifying Patients With the COPD-Asthma Overlap Phenotype: Therapeutic Implications

NCT02985814 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 271

Last updated 2018-02-06

No results posted yet for this study

Summary

Background: Asthma and COPD are considered different diseases but many patients share characteristics of both entities. This has been termed "COPD-asthma overlap syndrome".

Study objective: To examine: (a) the frequency of the overlap phenotype among patients referred for pulmonary function testing and, (b) the impact of this phenotype on the therapeutic management and the quality of life of these patients as compared with patients with COPD only and asthma only.

Methods:

Type of study: Observational, cross-sectional. Study subjects: Patients referred for pulmonary function test diagnosed with airway obstruction (FEV1/FVC \< 0.7) willing to sign an informed consent.

Study procedures: Spirometry will be performed before and after the administration of a bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history of asthma and wheezing, current medications and history of exacerbations will be administered at inclusion. Questionnaire on medication utilization will be administered by telephone one month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory Questionnaire (SGRQ).

Working definitions: The following definitions will be adopted: a) COPD only: smoking history \> 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of \< 0.70; b) Asthma only: (1) presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12% and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the overlap group) - the combination of the two.

Outcome measures: The clinical outcome is the prevalence rate of the phenotypes. Patient-reported outcomes will include the utilization of medication, the number of exacerbations, and quality of life.

Conditions

  • COPD Asthma

Sponsors & Collaborators

  • Clalit Health Services

    lead OTHER

Principal Investigators

  • Gabriel IZBICKI, MD · Clalit Health Services

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-04
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Israel

Study Locations

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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 NCT02985814 on ClinicalTrials.gov