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Prevalence of Bronchiectasis in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04101448
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
Aliae AR Mohamed Hussein, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Bronchiectasis Chronic Obstruct Airways Disease Prognosis Other: prevalence

Detailed 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?

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of and Prognostic Impact of Bronchiectasis in COPD Patients
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 30, 2020

Group/Cohort Intervention/treatment
Group A
COPD patients with bronchiectasis
Other: prevalence
percentage of bronchectasis in COPD and its effect as prognostic measure

Group B
COPD patients without bronchiectasis
Other: prevalence
percentage of bronchectasis in COPD and its effect as prognostic measure

Primary Outcome Measures :
  1. Prevalence of Bronchiectasis in COPD [ Time Frame: 1 year ]
    percentage of bronchiectasis diagnosed by CT chest in COPD patients

Secondary Outcome Measures :
  1. impact of bronchiectasis on COPD exacerbations [ Time Frame: 1 year ]
    number of exacerbations treated in or out of hospitals

  2. impact of bronchiectasis on COPD hospitalization [ Time Frame: 1 year ]
    number of hospital admissions with acute exacerbations

  3. impact of bronchiectasis on COPD intensive care admission [ Time Frame: 1 year ]
    number of admissions in respiratory ICU and need for mechanical or non invasive ventilation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
COPD patients diagnosed based on GOLD criteria 2019 with chest CT finding of bronchiectasis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04101448

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Contact: Aliae Mohamed-Hussein 01222302352 ext 002

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AssiutU Recruiting
Assiut, Egypt, 71111
Contact: Aliae AR Mohamed-Hussein    +201222302352   
Sponsors and Collaborators
Assiut University

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Responsible Party: Aliae AR Mohamed Hussein, Professor of Pulmonology, Assiut University Identifier: NCT04101448    
Other Study ID Numbers: AssiutU7
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aliae AR Mohamed Hussein, Assiut University:
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases