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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03432026
Other study ID # COPD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date April 1, 2021

Study information

Verified date June 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 1, 2021
Est. primary completion date April 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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