COPDNCT01410422
Metabolomic Analysis of Exhaled Breath Condensates in Patients With COPD and Bronchiectasis
An observational study of COPD and Bronchiectasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Metabolomics is a large-scale approach to monitoring the compounds involved in cellular processes. It may reflect changes in biological function. Collection of exhaled breath is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the airway. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD, Bronchiectasis
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2011to Apr 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD and bronchiectasis
Who may be able to join
- patients with COPD or bronchiectasis
Who cannot join
- not willing to sign ICF
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ping-Hung Kuo, M.D., 886-972651067
About this study
Official title: Exhaled Breath Analysis in Patients With COPD and Bronchiectasis
Metabolomics is a large-scale approach to monitoring the compounds involved in cellular processes. It may reflect changes in biological function. Collection of exhaled breath is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the airway. This study is conducted for the metabolomic analysis of the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis.
Read the detailed description
Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. The aims of this study are: (1)Collecting and metabolomic profiling of the EBCs from patients with COPD/bronchiectasis; (2) Comparing the profiles of these patients obtained during stable and acute exacerbation periods; (3) Comparing the profiles of these patients with and without Pseudomonas colonization/infection; (4) Correlation of EBC metabolomic profiles with clinical phenotypes, severity and outcomes of these patients.
- Conditions
- COPD, Bronchiectasis
- Keywords
- COPD, Bronchiectasis, Metabolomics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis
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 | COPD | |
| Bronchiectasis | Bronchiectasis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startMay 2011
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-Hung Kuo, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410422
- Sponsor's protocol ID
- 201103010RC
- Status last verified
- May 2011
- First submitted
- 4 Aug 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis in Patients With COPD and Bronchiectasis
- ClinicalTrials.gov ID
- NCT01410422
- Acronym / sponsor ID
- 201103010RC
- Conditions
- COPD, Bronchiectasis
- Keywords
- COPD, Bronchiectasis, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2011
- Study completion
- Apr 2014 (estimated)
- First posted
- 5 Aug 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.
Metabolomics is a large-scale approach to monitoring the compounds involved in cellular processes. It may reflect changes in biological function. Collection of exhaled breath is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the airway. This study is conducted for the metabolomic analysis of the exhaled gas in patients with Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis.
Detailed description
Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. The aims of this study are: (1)Collecting and metabolomic profiling of the EBCs from patients with COPD/bronchiectasis; (2) Comparing the profiles of these patients obtained during stable and acute exacerbation periods; (3) Comparing the profiles of these patients with and without Pseudomonas colonization/infection; (4) Correlation of EBC metabolomic profiles with clinical phenotypes, severity and outcomes of these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –COPD |
| Bronchiectasis | – | –Bronchiectasis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD and bronchiectasis
Key inclusion criteria (1 listed)
- patients with COPD or bronchiectasis
Key exclusion criteria (1 listed)
- not willing to sign ICF
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
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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.
Ping-Hung Kuo, M.D. principal investigator
National Taiwan University Hospital
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 COPD and Bronchiectasis, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 5 Aug 2011. 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 Taiwan. 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 Ping-Hung Kuo (886-972651067, Kph712@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 5 Aug 2011.