COPDCAPTANCT01378039
Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases
A study testing comparison of treatment effect on different markers in people with COPD and Asthma, run by Lithuanian University of Health Sciences.
Trial summary
Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to even increase in many countries. Both from a clinical and a pathophysiological point of view, this is an important issue. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- What is being tested?
- comparison of treatment effect on different markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 2009
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged 40-80 years inclusive.
- An established clinical history of COPD as defined by the GOLD guidelines.
- COPD patients with a baseline (pre-bronchodilator) FEV1 40-80% of predicted normal value; post-bronchodilator FEV1/FVC ratio ≤ 70% predicted.
- COPD patients with a smoking history (current or ex-smoker) of ≥10 pack years or those who have exposure to occupational dust and chemicals
- An established clinical history of asthma defined by the GINA recommendations.
- Subjects with out hypoxemia (all subjects must have an O2 saturation ≥88% on room air).
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- Control (healthy) subjects with baseline FEV1 >80% of predicted normal value
- A female is eligible to participate this study if she is of non-childbearing potential, or childbearing potential has a negative pregnancy test.
- Patients who did not use inhaled and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.
Who cannot join
- There is a current respiratory disorder other than COPD and asthma (e.g. lung cancer, sarcoidosis, active tuberculosis etc.)
- Subjects who have had a COPD and asthma exacerbation or respiratory infection in the 4 weeks before Visit 1.
- Subjects with a chest X-ray indicating diagnosis other than COPD or asthma that might interfere with the study.
- Subjects who are unable to stop treatment with inhaled, and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.
- Subjects receiving treatment with cromolyn sodium or nedocromil, oral beta2 - agonists, long acting anticholinergic, leucotriene modifiers
- Subjects who have had lung surgery.
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- Subjects with bleeding diathesis.
- Subjects receiving treatment with long-term oxygen therapy.
- Subjects with serious, uncontrolled diseases those are uncontrolled on permitted therapy.
About this study
Official title: Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases
Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to even increase in many countries. Both from a clinical and a pathophysiological point of view, this is an important issue. However, an understanding of the relationship between the complex array of cells and mediators involved in asthma and COPD is not yet fully dissected which makes difficult to find a specific and sensitive panel of biomarkers that can reflect intensity of these pathological processes and can help to predict the individual outcome.
Read the detailed description
Objectives:
To evaluate the patterns of pathophysiology and genetic predisposition of COPD and asthma
Tasks:
To evaluate patients that respond to corticosteroids and those who do not
Compare the inflammatory markers:
- of COPD and asthma patients before and after treatment with inhaled glucocorticoids
- of COPD and asthma patients that respond to inhaled glucocorticoids and those who do not
- of nonsmokers and smokers asthma patients
To identify a small set of markers that can be used to predict corticosteroid-treatment response in patients with COPD.
To evaluate epigenetic factors
To compare gene mutation and polymorphism between study groups
To evaluate the relationship between genetic predisposition and pathophysiology, clinical symptoms
To evaluate the relationship between patterns of pathophysiology and clinical symptoms, lung function, quality of life in patients with chronic obstructive pulmonary diseases.
Visit 1 Written informed consent will be obtained
- A full medical, surgical, smoking, labour history. A physical examination will be performed
- Resting SaO2 will be measured, exhaled nitric oxide (FENO)
- Chest X-ray
- Patient will fulfil questionnaires
- Spirometry and bronchodilatation test
- Sputum induction and samples will be performed
Visit 2 • Blood samples for blood clotting test and immunological markers will be taken• Cough inhalation challenge
Visit 3
- Patient will be hospitalized to the Department of Pulmonology and Immunology
- Blood samples for genetic analysis will be taken
- Urinary samples will be taken• Methacholine challenge test Polysomnography
- Bronchoscopy (biopsy and BAL)
- Study drug administration
Visit 4 and 5
- Adverse events, COPD or asthma exacerbation, concomitant medications will be recorded, exhaled nitric oxide (FENO)
- Spirometry
- Patient will fulfil questionnaires
- Cough inhalation challenge
Visit 6
- Patient will fulfil questionnaires
- Spirometry and bronchodilatation test.
- Sputum induction and samples will be performed
Visit 7
- Blood samples for blood clotting test, immunological and genetic analysis will be taken• Cough inhalation challenge
Visit 8
- Patient will be hospitalized to the Department of Pulmonology and Immunology
- Urinary samples will be taken• Methacholine challenge test Polysomnography
- Bronchoscopy (biopsy and BAL)
- Further treatment administration
- Being tested
- comparison of treatment effect on different markers
- Keywords
- COPD, Asthma, Pathophysiology, Genetics, Phenotype, Treatment response
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of treatment effect on different markersDrug
Also called Budesonide
inhaled budesonide (400 µg BD) or placebo BD
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Other | patients who gave their agreement were randomised to 3 months treatment with either inhaled budesonide (400 µg BD) or placebo Receives: Drug: comparison of treatment effect on different markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months
inflammatory cell numbers and inflammatory markers (cytokines, chemokines, etc.) in different tissue compartments (induced sputum, BAL, bronchial biopsies, blood) will be measured at baseline and 3 months after treatment with budesonide and compared with those from healthy subjects
Measured: 3 months
Secondary outcomes (2)
network analysis of quantitative proteomics of bronchial biopsies
pathways analysis will be performed on proteins obtained from bronchial biopsies from asthmatics and COPD patients at baseline and 3 months after treatment
Measured: 3 months
change of lung function, exNO after 3 months of treatment
lung function measurements (spirometry, bronchial responsiveness measurement, capsaicin test) at baseline and 3 months after treatment with budesonide
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Raimundas Sakalauskas, Lithuanian University of Health Sciences
- Investigators
- Raimundas Sakalauskas, Prof., Principal investigator, Kaunas University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378039
- Sponsor's protocol ID
- 48/2004
- Acronym
- CAPTA
- Status last verified
- Apr 2012
- First submitted
- 31 May 2011
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Neil SE, Sitkauskiene B, Babusyte A, Krisiukeniene A, Stravinskaite-Bieksiene K, Sakalauskas R, Sihlbom C, Ekerljung L, Carlsohn E, Lotvall J. Network analysis of quantitative proteomics on asthmatic bronchi: effects of inhaled glucocorticoid treatment. Respir Res. 2011 Sep 22;12(1):124. doi: 10.1186/1465-9921-12-124.
PubMed 21939520
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT01378039
- Acronym / sponsor ID
- CAPTA / 48/2004
- Keywords
- COPD, Asthma, Pathophysiology, Genetics, Phenotype, Treatment response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Jun 2011 (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 common diseases, which tend to even increase in many countries. Both from a clinical and a pathophysiological point of view, this is an important issue. However, an understanding of the relationship between the complex array of cells and mediators involved in asthma and COPD is not yet fully dissected which makes difficult to find a specific and sensitive panel of biomarkers that can reflect intensity of these pathological processes and can help to predict the individual outcome.
Detailed description
Objectives:
To evaluate the patterns of pathophysiology and genetic predisposition of COPD and asthma
Tasks:
To evaluate patients that respond to corticosteroids and those who do not
Compare the inflammatory markers:
- of COPD and asthma patients before and after treatment with inhaled glucocorticoids
- of COPD and asthma patients that respond to inhaled glucocorticoids and those who do not
- of nonsmokers and smokers asthma patients
To identify a small set of markers that can be used to predict corticosteroid-treatment response in patients with COPD.
To evaluate epigenetic factors
To compare gene mutation and polymorphism between study groups
To evaluate the relationship between genetic predisposition and pathophysiology, clinical symptoms
To evaluate the relationship between patterns of pathophysiology and clinical symptoms, lung function, quality of life in patients with chronic obstructive pulmonary diseases.
Visit 1 Written informed consent will be obtained
- A full medical, surgical, smoking, labour history. A physical examination will be performed
- Resting SaO2 will be measured, exhaled nitric oxide (FENO)
- Chest X-ray
- Patient will fulfil questionnaires
- Spirometry and bronchodilatation test
- Sputum induction and samples will be performed
Visit 2 • Blood samples for blood clotting test and immunological markers will be taken• Cough inhalation challenge
Visit 3
- Patient will be hospitalized to the Department of Pulmonology and Immunology
- Blood samples for genetic analysis will be taken
- Urinary samples will be taken• Methacholine challenge test Polysomnography
- Bronchoscopy (biopsy and BAL)
- Study drug administration
Visit 4 and 5
- Adverse events, COPD or asthma exacerbation, concomitant medications will be recorded, exhaled nitric oxide (FENO)
- Spirometry
- Patient will fulfil questionnaires
- Cough inhalation challenge
Visit 6
- Patient will fulfil questionnaires
- Spirometry and bronchodilatation test.
- Sputum induction and samples will be performed
Visit 7
- Blood samples for blood clotting test, immunological and genetic analysis will be taken• Cough inhalation challenge
Visit 8
- Patient will be hospitalized to the Department of Pulmonology and Immunology
- Urinary samples will be taken• Methacholine challenge test Polysomnography
- Bronchoscopy (biopsy and BAL)
- Further treatment administration
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Other | Drug: comparison of treatment effect on different markerspatients who gave their agreement were randomised to 3 months treatment with either inhaled budesonide (400 µg BD) or placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female outpatients aged 40-80 years inclusive.
- An established clinical history of COPD as defined by the GOLD guidelines.
- COPD patients with a baseline (pre-bronchodilator) FEV1 40-80% of predicted normal value; post-bronchodilator FEV1/FVC ratio ≤ 70% predicted.
- COPD patients with a smoking history (current or ex-smoker) of ≥10 pack years or those who have exposure to occupational dust and chemicals
- An established clinical history of asthma defined by the GINA recommendations.
Key exclusion criteria (9 listed)
- There is a current respiratory disorder other than COPD and asthma (e.g. lung cancer, sarcoidosis, active tuberculosis etc.)
- Subjects who have had a COPD and asthma exacerbation or respiratory infection in the 4 weeks before Visit 1.
- Subjects with a chest X-ray indicating diagnosis other than COPD or asthma that might interfere with the study.
- Subjects who are unable to stop treatment with inhaled, and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.
- Subjects receiving treatment with cromolyn sodium or nedocromil, oral beta2 - agonists, long acting anticholinergic, leucotriene modifiers
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 |
|---|---|---|
| comparison of treatment effect on different markersAlso: Budesonideinhaled budesonide (400 µg BD) or placebo BD | Drug | Budesonide |
Primary outcome
Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months
Time frame: 3 months
inflammatory cell numbers and inflammatory markers (cytokines, chemokines, etc.) in different tissue compartments (induced sputum, BAL, bronchial biopsies, blood) will be measured at baseline and 3 months after treatment with budesonide and compared with those from healthy subjects
2 secondary outcomes
network analysis of quantitative proteomics of bronchial biopsies
Time frame: 3 months
change of lung function, exNO after 3 months of treatment
Time frame: 3 months
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 12 Apr 2012.
- Derived from this study: PubMed 21939520O'Neil SE, Sitkauskiene B, Babusyte A, Krisiukeniene A, Stravinskaite-Bieksiene K, Sakalauskas R, Sihlbom C, Ekerljung L, Carlsohn E, Lotvall J. Network analysis of quantitative proteomics on asthmatic bronchi: effects of inhaled glucocorticoid treatment. Respir Res. 2011 Sep 22;12(1):124. doi: 10.1186/1465-9921-12-124.
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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.
Raimundas Sakalauskas, Prof. principal investigator
Kaunas University of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing comparison of treatment effect on different markers in people with COPD and Asthma, run by Lithuanian University of Health Sciences.
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 9 inclusion and 9 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 12 Apr 2012. 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?
Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378039, which also lists 1 linked publication.
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 12 Apr 2012.