Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap

• Conditions: COPD, Asthma,ACO

• Registration Number: NCT04056364
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to evaluate the diagnostic value of sputum cell counts in differentiation between asthma, COPD and ACO.

to examine the relationship between sputum cell counts in bronchial revers¬ibility and bronchial hyperresponsiveness

Detailed Description

Asthma and COPD are considered as chronic airway inflammatory diseases, which are typically associated with Th2-mediated immune response in asthma and related to the characteristics of Th1-mediated immunity in COPD . Asthma-COPD overlap (ACO) is the term to describe patients who have features of both asthma and COPD, recom¬mended by the 2019 Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstruction Lung Disease (GOLD) guidelines. Patients with asthma and COPD are commonly seen in clinical practice. In addition, compared with patients with asthma or COPD alone, patients with ACO experience frequent exacerbations and hospitalizations, have poor quality of life, a more rapid decline in lung function and high mortality, and consume a disproportionate amount of health care resources than asthma or COPD alone .

Cell count in induced sputum is a noninvasive biomarker to assess airway inflammation phenotypes. Accordingly, sputum cell counts are extensively used in the treatment of asthma and COPD. Nevertheless, the clinical application of sputum cell counts in patients with asthma-COPD overlap (ACO) remains elusive .

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Study Start: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• all patients known to be Asthma, COPD, ACO

Exclusion Criteria

• Patients will be excluded if they have confounding pulmonary comorbidities, such as pulmonary tuberculosis, interstitial lung disease, lung cancer or pulmonary infection, and had a cognitive impairment that may affect the collaboration or comprehension of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of sputum cytology in Asthma , COPD, ACO	Baseline	A differential cell count will be obtained from 400 cells under 400× microscope to identify the severity and type of airway inflammation in all patients. Squamous cell count less than 10% in each sample will be deemed adequate for further analysis.