Chronic Obstructive Pulmonary Disease Phenotypes in Non-Smokers

Phenotypes of COPD



Sponsors

Lead Sponsor



Source

Assiut University

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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.

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.

Overall Status

Not yet recruiting

Start Date

2018-04-01

Completion Date

2020-04-01

Primary Completion Date

2019-04-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Rate of risk factors of COPD in non smokers.
48 hour

Number Of Groups

1

Enrollment

50

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

High resolution computed tomography scan of the chest & pulmonary function tests will be done for every patient to classify them.

Arm Group Label

Non-smoker COPD patients


Eligibility

Study Pop

Non smoker COPD stable patients

Sampling Method

Non-Probability Sample

Criteria

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.

Gender

All

Minimum Age

N/A

Maximum Age

N/A


Verification Date

2018-01-01

Lastchanged Date

2018-02-07

Firstreceived Date

2018-01-22

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Assiut University

Investigator Full Name

C F Shamshon

Investigator Title

Principal investigator


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Non-smoker COPD patients

Description

stable non-smoker COPD patients diagnosed by a previous spiromtery to have FEV1/FVC less than 70


Firstreceived Results Date

N/A

Reference

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.

PMID

28360456


Citation

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.

PMID

27890988



Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Only

Time Perspective

Prospective


Study First Submitted

January 22, 2018

Study First Submitted Qc

February 7, 2018

Study First Posted

February 13, 2018

Last Update Submitted

February 7, 2018

Last Update Submitted Qc

February 7, 2018

Last Update Posted

February 13, 2018


ClinicalTrials.gov processed this data on February 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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