Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap

NCT04056364 | Unknown

• 1 other identifier: sputum cytology
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

COPD, Asthma,ACO

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Asthma

Asthma patients will be diagnosed according to a clinical history of wheezing, cough, chest tightness or shortness of breath, as well as the presence of BHR (cumulative dose caus¬ing a 20% decrease in FEV1), based on the GINA guidelines. None of them had a history of COPD, or previous doctor-diagnosed ACO. All subjects had not used any oral or/and inhaled corticosteroid (ICS) in the previous 12 weeks. The included patients with asthma had initial diagnosis and were under uncontrolled stage.

Biological: sputum cytology

COPD

COPD patients were diagnosed according to the GOLD criterion, which included a post-bronchodilator spirometry to confirm airflow obstruction (FEV1 to forced vital capacity ratio \[FEV1/FVC\] ,70%), in a clinical context (dyspnea, chronic cough or sputum production, and a history of expo¬sure to risk factors for the disease). They had received a COPD diagnosis at least 1 year before the study. None of them had a history of asthma. All subjects had not used any oral or/and ICS in the previous 4 weeks. The included COPD patients had exacerbations. The GOLD stage of COPD was defined according to the 2019 recommendations of GOLD.

Biological: sputum cytology

ACO

ACO will be diagnosed by two steps: the first step is the identification of a history of chronic airway disease, i.e., chronic or recurrent cough, sputum production, wheezing, or repeated acute lower respiratory tract infections. In the second step, the features of asthma and those of COPD that best describe the patients

Biological: sputum cytology

Interventions

sputum cytology BIOLOGICAL

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.

ACO; Asthma; COPD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients known have Asthma, COPD, ACO . age from 18 years until 75

You may qualify if:

• all patients known to be Asthma, COPD, ACO

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 29499062 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hesham Memo, resident

CONTACT

01094813767; hesham.memo1117@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 20, 2019

Record last verified: 2019-08