BronchiectasisNCT04101448
Prevalence of Bronchiectasis in COPD Patients
An observational study of Bronchiectasis and Chronic Obstruct Airways Disease, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis, Chronic Obstruct Airways Disease, Prognosis
- What is being tested?
- prevalence
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: COPD patients diagnosed based on GOLD criteria 2019 with chest CT finding of bronchiectasis
Who may be able to join
- COPD patients based on GOLD 2019 criteria, stable or in exacerbation
Who cannot join
- acute pneumonia within 2 months
- malignancy
- congenital bronchiectasis ( immobile cilia syndrome, Kartagnar syndrome).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AssiutU
Asyut, 71111
Aliae AR Mohamed-Hussein, +201222302352, aliaehussein@gmail.com
About this study
Official title: 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.
Read the 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?
- Conditions
- Bronchiectasis, Chronic Obstruct Airways Disease, Prognosis
- Being tested
- prevalence
- Keywords
- Bronchiectasis, COPD, Prevalence, Prognosis
- Medical subject headings
- Bronchiectasis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevalenceOther
percentage of bronchectasis in COPD and its effect as prognostic measure
| Study group | Role | What they receive |
|---|---|---|
| Group A | COPD patients with bronchiectasis Receives: Other: prevalence | |
| Group B | COPD patients without bronchiectasis Receives: Other: prevalence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Bronchiectasis in COPD
percentage of bronchiectasis diagnosed by CT chest in COPD patients
Measured: 1 year
Secondary outcomes (3)
impact of bronchiectasis on COPD exacerbations
number of exacerbations treated in or out of hospitals
Measured: 1 year
impact of bronchiectasis on COPD hospitalization
number of hospital admissions with acute exacerbations
Measured: 1 year
impact of bronchiectasis on COPD intensive care admission
number of admissions in respiratory ICU and need for mechanical or non invasive ventilation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start30 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101448
- Sponsor's protocol ID
- AssiutU7
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of and Prognostic Impact of Bronchiectasis in COPD Patients
- ClinicalTrials.gov ID
- NCT04101448
- Acronym / sponsor ID
- AssiutU7
- Conditions
- Bronchiectasis, Chronic Obstruct Airways Disease, Prognosis
- Keywords
- Bronchiectasis, COPD, Prevalence, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: prevalenceCOPD patients with bronchiectasis |
| Group B | – | Other: prevalenceCOPD patients without bronchiectasis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COPD patients diagnosed based on GOLD criteria 2019 with chest CT finding of bronchiectasis
Key inclusion criteria (1 listed)
- COPD patients based on GOLD 2019 criteria, stable or in exacerbation
Key exclusion criteria (4 listed)
- acute pneumonia within 2 months
- malignancy
- congenital bronchiectasis ( immobile cilia syndrome, Kartagnar syndrome).
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevalencepercentage of bronchectasis in COPD and its effect as prognostic measure | Other | Group A, Group B |
Primary outcome
Prevalence of Bronchiectasis in COPD
Time frame: 1 year
percentage of bronchiectasis diagnosed by CT chest in COPD patients
3 secondary outcomes
impact of bronchiectasis on COPD exacerbations
Time frame: 1 year
impact of bronchiectasis on COPD hospitalization
Time frame: 1 year
impact of bronchiectasis on COPD intensive care admission
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Chronic Obstruct Airways Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliae Mohamed-Hussein (01222302352 ext. 002, aliaehussein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Bronchiectasis in COPD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.