BronchiectasisNCT03950531
The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD
An observational study of Bronchiectasis and Chronic Obstructive Pulmonary Disease, run by Ministry of Health, Turkey.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Bronchiectasis, Chronic Obstructive Pulmonary Disease
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2010to 25 Jan 2017
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with COPD exacerbation
Who may be able to join
- Patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study
Who cannot join
- Cases that mimic COPD exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-COPD overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.
About this study
Official title: The Effect of Bronchiectasis on the Exacerbation and Mortality of Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. COPD exacerbations are characterized by worsening of dyspnea, coughing and expectoration. Exacerbations requiring hospitalization are the main cause of morbidity and mortality in COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. The association of bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.
- Being tested
- No intervention
- Keywords
- Bronchiectasis, Chronic Obstructive Pulmonary Disease, Exacerbation, Computed Tomography
- 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.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| COPD exacerbation without Bronchiectasis | COPD patients who have been in exacerbation period and have no bronchiectasis Receives: Other: No intervention | |
| COPD exacerbation with Bronchiectasis | COPD patients who have been in exacerbation period and have bronchiectasis Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Charlson Comorbidity Index
Comorbidity scores
Measured: 1 hour
Secondary outcomes (1)
Spirometry
Pulmonary function measurement
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start25 Jan 2010
- Primary completion25 Dec 2014
- Study completion25 Jan 2017
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.
- 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
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Turkey
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep FENDOGLU, Ministry of Health, Turkey
- Investigators
- Nurdan Kokturk, Professor, Study chair, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950531
- Sponsor's protocol ID
- 123678
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bronchiectasis on the Exacerbation and Mortality of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03950531
- Acronym / sponsor ID
- 123678
- Keywords
- Bronchiectasis, Chronic Obstructive Pulmonary Disease, Exacerbation, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Ministry of Health, TurkeyOther government
- Study start
- 25 Jan 2010 (actual)
- Primary completion
- 25 Dec 2014 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 15 May 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.
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. COPD exacerbations are characterized by worsening of dyspnea, coughing and expectoration. Exacerbations requiring hospitalization are the main cause of morbidity and mortality in COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. The association of bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD exacerbation without Bronchiectasis | – | Other: No interventionCOPD patients who have been in exacerbation period and have no bronchiectasis |
| COPD exacerbation with Bronchiectasis | – | Other: No interventionCOPD patients who have been in exacerbation period and have bronchiectasis |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with COPD exacerbation
Key inclusion criteria (1 listed)
- Patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study
Key exclusion criteria (1 listed)
- Cases that mimic COPD exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-COPD overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.
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 |
|---|---|---|
| No intervention | Other | COPD exacerbation with Bronchiectasis, COPD exacerbation without Bronchiectasis |
Primary outcome
Charlson Comorbidity Index
Time frame: 1 hour
Comorbidity scores
1 secondary outcome
Spirometry
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: No
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Bronchiectasis
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.
Nurdan Kokturk, Professor study chair
Gazi University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Chronic Obstructive Pulmonary Disease, run by Ministry of Health, Turkey.
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 1 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: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Charlson Comorbidity Index (time frame: 1 hour). 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 17 May 2019.