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Phenotypes of COPD

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ClinicalTrials.gov Identifier: NCT03432026
Recruitment Status : Not yet recruiting
First Posted : February 13, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
C F Shamshon, Assiut University

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.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chronic Obstructive Pulmonary Disease Phenotypes in Non-Smokers
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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.




Primary Outcome Measures :
  1. Rate of risk factors of COPD in non smokers. [ Time Frame: 48 hour ]
    Complete medical history will be taken for each patient to detect risk factors of COPD.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Non smoker COPD stable patients
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.

Publications:
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Responsible Party: C F Shamshon, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03432026     History of Changes
Other Study ID Numbers: COPD
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases