AsthmaNCT02069054
Airway Inflammation and Remodeling in Asthma and COPD.
An observational study of Asthma and COPD, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2012to Aug 2015
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with stable asthma and COPD invited to Clinical Hospital in Warsaw
Who may be able to join
- a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
- control group - healthy volunteers without any history of lung disease
Who cannot join
- age below 18 years
- exacerbation in the past 6 weeks
- inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
- significant co-morbidities
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw 02-097
Warsaw, 02-097
About this study
Official title: Relationship Between Airway Inflammation and Remodeling in Asthma and COPD Patients.
Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects.
The aim of this study is:
Read more
- to evaluate airway inflammation in asthma and COPD,
- to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
- to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients.
Material and methods:
- mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
- mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
- healthy subjects as controls.
Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.
We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.
- Keywords
- asthma, COPD, airway inflammation, remodeling, cytokines, airway wall thickness
- Medical subject headings
- Asthma, 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 |
|---|---|---|
| Asthma | Patients with mild to moderate asthma diagnosed in accordance with GINA | |
| COPD | Patients with mild to moderate COPD diagnosed in accordance with GOLD | |
| Control | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
Inflammatory markers in exhaled breath condensate and induced sputum in healthy subjects, COPD and asthma patients.
Measured: Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)
Airway wall thickness
Airway wall thickness in healthy subject, COPD and asthma patients assessed by HRCT and EBUS
Measured: Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069054
- Sponsor's protocol ID
- IPU-DIMPA-WUM13(2)
- Status last verified
- Feb 2014
- First submitted
- 19 Feb 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Airway Inflammation and Remodeling in Asthma and COPD Patients.
- ClinicalTrials.gov ID
- NCT02069054
- Acronym / sponsor ID
- IPU-DIMPA-WUM13(2)
- Keywords
- asthma, COPD, airway inflammation, remodeling, cytokines, airway wall thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Feb 2014 (estimated)
- 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.
Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects.
The aim of this study is:
- to evaluate airway inflammation in asthma and COPD,
- to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
- to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients.
Material and methods:
- mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
- mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
- healthy subjects as controls.
Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.
We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –Patients with mild to moderate asthma diagnosed in accordance with GINA |
| COPD | – | –Patients with mild to moderate COPD diagnosed in accordance with GOLD |
| Control | – | –Healthy subjects |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with stable asthma and COPD invited to Clinical Hospital in Warsaw
Key inclusion criteria (2 listed)
- a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
- control group - healthy volunteers without any history of lung disease
Key exclusion criteria (4 listed)
- age below 18 years
- exacerbation in the past 6 weeks
- inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
- significant co-morbidities
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
Inflammatory markers
Time frame: Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)
Inflammatory markers in exhaled breath condensate and induced sputum in healthy subjects, COPD and asthma patients.
Airway wall thickness
Time frame: Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)
Airway wall thickness in healthy subject, COPD and asthma patients assessed by HRCT and EBUS
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 27 Apr 2016.
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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.
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 Asthma and COPD, run by Medical University of Warsaw at 1 site in Poland.
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 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: finished, as of the sponsor's last update on 27 Apr 2016. 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 Poland. 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?
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?
Inflammatory markers (time frame: Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)). The study lists 2 primary outcomes in all. 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 27 Apr 2016.