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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04101448
Other study ID # AssiutU7
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date September 30, 2020

Study information

Verified date September 2019
Source Assiut University
Contact Aliae Mohamed-Hussein
Phone 01222302352
Email aliaehussein@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The identification of bronchiectasis in COPD has been defined as a different clinical COPD phenotype with greater symptomatic severity, more frequent chronic bronchial infection and exacerbations, and poor prognosis. A causal association has not yet been proven, but it is biologically plausible that COPD, and particularly the infective and exacerbator COPD phenotypes, could be the cause of bronchiectasis without any other known etiology, beyond any mere association or comorbidity.


Description:

The relationship between bronchiectasis and COPD has generated several questions. Is there any real increased prevalence of bronchiectasis in patients with COPD? Does the presence of bronchiectasis have an impact on the clinical characteristics, prognosis, or response to treatment in COPD, to the extent that it can be considered a distinct clinical phenotype? Should bronchiectasis in patients with COPD be seen as merely a comorbidity, or as a consequence of the disease's natural history? Is there a causal relationship between COPD and bronchiectasis? If this is the case, what are the pathophysiological mechanisms responsible for this relationship? And, finally, what is the role of chronic bronchial infection and exacerbations in this relationship?


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 30, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- COPD patients based on GOLD 2019 criteria, stable or in exacerbation

Exclusion Criteria:

- acute pneumonia within 2 months

- malignancy

- congenital bronchiectasis ( immobile cilia syndrome, Kartagnar syndrome).

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
prevalence
percentage of bronchectasis in COPD and its effect as prognostic measure

Locations

Country Name City State
Egypt AssiutU Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Bronchiectasis in COPD percentage of bronchiectasis diagnosed by CT chest in COPD patients 1 year
Secondary impact of bronchiectasis on COPD exacerbations number of exacerbations treated in or out of hospitals 1 year
Secondary impact of bronchiectasis on COPD hospitalization number of hospital admissions with acute exacerbations 1 year
Secondary impact of bronchiectasis on COPD intensive care admission number of admissions in respiratory ICU and need for mechanical or non invasive ventilation 1 year
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