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

NCT02985814 | Completed

• 1 other identifier: 0066-14-COM
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COPD Asthma Overlap

Outcome Measures

Primary Outcomes (1)

• utilization of medication

  completion of RS questionnaires

  enrollment to 2 months

Secondary Outcomes (2)

• number of exacerbations

  enrollment to 2 months

• quality of life

  enrollment

Study Arms (1)

patients with airway obstruction

Patients referred for pulmonary function test diagnosed with airway obstruction (FEV1/FVC \< 0.7) willing to sign an informed consent.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

men or women aged \> 18 years, with spirometric evidence of airway obstruction defined as an FEV1/FVC ratio \< 0.7

You may qualify if:

• men or women aged \> 18 years , with spirometric evidence of airway obstruction defined as an FEV1/FVC ratio \< 0.7

You may not qualify if:

• Subjects with normal spirometry or presenting a pattern of restrictive lung disease will be listed for the purpose of characterising the source population but will not enter the study

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (1)

ROKACH institute

Jerusalem, Israel

Location

Study Officials

• Gabriel IZBICKI, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: February 4, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)