BronchiectasisNCT03670940
Bronchiectasis Effect in COPD Patients
An observational study of Bronchiectasis and Copd, run by Izmir Katip Celebi University.
Trial summary
The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Copd
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with and without bronchiectasis.
Who may be able to join
- above 18 years old
- clinically stable
Who cannot join
- other respiratory disease
About this study
Official title: Effect of Bronchiectasis on Respiratory Functions, Exercise Capacity, Dyspnea Perception and Quality of Life in COPD Patients
The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.
Read the detailed description
The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.
Torax CTs of patients with COPD who are admitted to the outpatient clinic will be examined. There will be two groups, group 1 in patients with COPD accompanied by bronchiectasis and group 2 in COPD patients without bronchiectasis. In both groups, respiratory function tests, exercise capacities, dyspnea perceptions and quality of life will be evaluated. The data will be compared between the two groups.
- Conditions
- Bronchiectasis, Copd
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | COPD patients without bronchiectasis | |
| COPD and bronchiectasis patients | COPD patients with bronchiectasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
six minute walk test
Measured: 15 minutes
Secondary outcomes (3)
Dyspnea Severity
mMRC Dyspnea Scale (0: no dyspnea, 4: very severe dyspnea)
Measured: 5 minutes
Lung Function
Respiratory Function Test
Measured: 20 minutes
Health Related Quality of Life
St. George Respiratory Questionnaire (maximum score: 100, lower score means better quality of life)
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startJan 2015
- Primary completionMar 2018
- Study completionApr 2018
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670940
- Sponsor's protocol ID
- IKC
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bronchiectasis on Respiratory Functions, Exercise Capacity, Dyspnea Perception and Quality of Life in COPD Patients
- ClinicalTrials.gov ID
- NCT03670940
- Acronym / sponsor ID
- IKC
- Conditions
- Bronchiectasis, Copd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 14 Sep 2018 (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 etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.
Detailed description
The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.
Torax CTs of patients with COPD who are admitted to the outpatient clinic will be examined. There will be two groups, group 1 in patients with COPD accompanied by bronchiectasis and group 2 in COPD patients without bronchiectasis. In both groups, respiratory function tests, exercise capacities, dyspnea perceptions and quality of life will be evaluated. The data will be compared between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | –COPD patients without bronchiectasis |
| COPD and bronchiectasis patients | – | –COPD patients with bronchiectasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with and without bronchiectasis.
Key inclusion criteria (2 listed)
- above 18 years old
- clinically stable
Key exclusion criteria (1 listed)
- other respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise capacity
Time frame: 15 minutes
six minute walk test
3 secondary outcomes
Dyspnea Severity
Time frame: 5 minutes
Lung Function
Time frame: 20 minutes
Health Related Quality of Life
Time frame: 25 minutes
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 14 Sep 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Copd, run by Izmir Katip Celebi University.
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 2 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 14 Sep 2018. 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?
Exercise capacity (time frame: 15 minutes). 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 14 Sep 2018.