- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101448
Prevalence of Bronchiectasis in COPD Patients
September 22, 2019 updated by: Aliae AR Mohamed Hussein, Assiut University
Prevalence of and Prognostic Impact of Bronchiectasis in COPD Patients
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71111
- Recruiting
- AssiutU
-
Contact:
- Aliae AR Mohamed-Hussein
- Phone Number: +201222302352
- Email: aliaehussein@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders 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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
COPD patients with bronchiectasis
|
percentage of bronchectasis in COPD and its effect as prognostic measure
|
Group B
COPD patients without bronchiectasis
|
percentage of bronchectasis in COPD and its effect as prognostic measure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Bronchiectasis in COPD
Time Frame: 1 year
|
percentage of bronchiectasis diagnosed by CT chest in COPD patients
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
impact of bronchiectasis on COPD exacerbations
Time Frame: 1 year
|
number of exacerbations treated in or out of hospitals
|
1 year
|
impact of bronchiectasis on COPD hospitalization
Time Frame: 1 year
|
number of hospital admissions with acute exacerbations
|
1 year
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 30, 2019
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
September 30, 2020
Study Registration Dates
First Submitted
September 22, 2019
First Submitted That Met QC Criteria
September 22, 2019
First Posted (Actual)
September 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 22, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutU7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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