Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap

COPD, Asthma,ACO Clinical Trial

Official title:

Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04056364
• Other study ID #: sputum cytology
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: October 2021

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: Hesham Memo, resident
• Phone: 01094813767
• Email: hesham.memo1117[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• COPD, Asthma,ACO

Intervention

Biological:
• sputum cytology
Sputum cytology refers to the examination of sputum (mucus) under a microscope to look for abnormal or cancerous cells. Sputum, or phlegm, is the fluid that is secreted by cells in the lower respiratory tract such as the bronchi and the trachea. It differs from saliva, in that it contains cells that line the respiratory passages.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Ojanguren I, Moullec G, Hobeika J, Miravitlles M, Lemiere C. Clinical and inflammatory characteristics of Asthma-COPD overlap in workers with occupational asthma. PLoS One. 2018 Mar 2;13(3):e0193144. doi: 10.1371/journal.pone.0193144. eCollection 2018. Erratum in: PLoS One. 2018 Apr 4;13(4):e0195648. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of sputum cytology in Asthma , COPD, ACO	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.	Baseline