Prevalence of Bronchiectasis in COPD Patients

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04101448
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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 Phase
  • 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?

Study Design

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

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of Bronchiectasis in COPD [1 year]

    percentage of bronchiectasis diagnosed by CT chest in COPD patients

Secondary Outcome Measures

  1. impact of bronchiectasis on COPD exacerbations [1 year]

    number of exacerbations treated in or out of hospitals

  2. impact of bronchiectasis on COPD hospitalization [1 year]

    number of hospital admissions with acute exacerbations

  3. impact of bronchiectasis on COPD intensive care admission [1 year]

    number of admissions in respiratory ICU and need for mechanical or non invasive ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AssiutU Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aliae AR Mohamed Hussein, Professor of Pulmonology, Assiut University
ClinicalTrials.gov Identifier:
NCT04101448
Other Study ID Numbers:
  • AssiutU7
First Posted:
Sep 24, 2019
Last Update Posted:
Sep 24, 2019
Last Verified:
Sep 1, 2019
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, Professor of Pulmonology, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2019