Phenotypes of COPD

Chronic Obstructive Pulmonary Disease Phenotypes in Non-Smokers

Chronic Obstructive Pulmonary Disease (COPD) has been defined by international guidelines as a common preventable and treatable disease characterized by persistent air flow limitation and respiratory symptoms caused by exposure to gases or noxious particles.

COPD is a major cause of morbidity and mortality worldwide. It is predicted to become the third leading cause of death and the fifth leading cause of disability by the year 2020.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: High resolution computed tomography scan of the chest.

Detailed Description

Although the disease has been greatly associated with tobacco smoking, non- smokers can also have COPD, and the burden of COPD in non-smokers is also higher than previously believed especially in developing countries. Exposure to gases, environmental pollution, respiratory infection, noxious particles, passive smoking, and indoor air pollution is the main cause of COPD in non smokers.

COPD over the years has been classified into two phenotypes; chronic bronchitis or classic emphysema.However, The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines over the last few years have stopped emphasizing the categorization of chronic obstructive pulmonary disease (COPD) into only emphysema or chronic bronchitis

Clear examples of COPD phenotypes in smokers have been described in different Researches,such as emphysema, chronic bronchitis, frequent exacerbators and the asthma_copd overlap.,but there is alack of information about COPD phenotypes in non-smokers, So, there is a continuous need for research into groups of non smoking patients.

Therefore, the aim of this study is to describe the phenotypes of COPD, their risk factors, Clinical and functional assessment and the prognosis of each COPD phenotype in non-smoking patients.

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Non smoker COPD stable patients

Description

Inclusion Criteria:

1. Non-smoker COPD patients.
2. Stable COPD patients (≥4 weeks without exacerbation or worsening of any relevant comorbidity).

Exclusion Criteria:

1. Patients with COPD exacerbation.
2. Patients with associated obstructive sleep apnea.
3. Patients with associated interstitial lung disease.
4. patients with associated cardiac problems.
5. Patients with associated bronchiaectasis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-smoker COPD patients; stable non-smoker COPD patients diagnosed by a previous spiromtery to have FEV1/FVC less than 70	Device: High resolution computed tomography scan of the chest.; High resolution computed tomography scan of the chest & pulmonary function tests will be done for every patient to classify them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of risk factors of COPD in non smokers.	Complete medical history will be taken for each patient to detect risk factors of COPD.	48 hour

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Sharma BB, Singh V. Nonsmoker COPD: Is it a reality? Lung India. 2017 Mar-Apr;34(2):117-119. doi: 10.4103/lungindia.lungindia_56_17. No abstract available.
• Mohan A, Sharma M, Uniyal A, Borah R, Luthra K, Pandey RM, Madan K, Hadda V, Guleria R. Variability in proteinase-antiproteinase balance, nutritional status, and quality of life in stable chronic obstructive pulmonary disease due to tobacco and nontobacco etiology. Lung India. 2016 Nov-Dec;33(6):605-610. doi: 10.4103/0970-2113.192859.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: COPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No