AsthmaNCT01246414
Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients
An observational study of Asthma, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 38 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to May 2010
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Asthmatic patients in Allergy clinic, King Chulalongkorn Memorial Hospital (10 allergic and 10 non-allergic) and 10 non-asthmatic controls will be enrolled to this study to collect exhaled breathe condensates (EBC) and measure levels of inflammatory cytokines in EBC
Who may be able to join
- Have been diagnosed as asthma at least 6 months before enrolled to the study
- Known skin prick test results to aeroallergens ; either positive or negative
- 15-65 years of age
Who cannot join
- On oral or inhaled corticosteroids within 1 month before the study
- Having asthma exacerbation
- Being pregnant
- Suffering from severe systemic disease/ in bad health
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients.
- Conditions
- Asthma
- Keywords
- Asthma, Exhaled breath condensates, Cytokines
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Allergic asthma | Patients with allergic asthma | |
| Non-allergic asthma | Patients with non-allergic asthma | |
| Non-asthmatic controls | Non-asthmatic controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of inflammatory cytokines in exhaled breathe condensates
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionMay 2010
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 AsthmaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246414
- Sponsor's protocol ID
- Chula-ARC 001/10
- Status last verified
- Nov 2010
- First submitted
- 4 Jan 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Boonpiyathad S, Pornsuriyasak P, Buranapraditkun S, Klaewsongkram J. Interleukin-2 levels in exhaled breath condensates, asthma severity, and asthma control in nonallergic asthma. Allergy Asthma Proc. 2013 Sep-Oct;34(5):e35-41. doi: 10.2500/aap.2013.34.3680.
PubMed 23998235
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients
- ClinicalTrials.gov ID
- NCT01246414
- Acronym / sponsor ID
- Chula-ARC 001/10
- Conditions
- Asthma
- Keywords
- Asthma, Exhaled breath condensates, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Nov 2010 (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.
This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allergic asthma | – | –Patients with allergic asthma |
| Non-allergic asthma | – | –Patients with non-allergic asthma |
| Non-asthmatic controls | – | –Non-asthmatic controls |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthmatic patients in Allergy clinic, King Chulalongkorn Memorial Hospital (10 allergic and 10 non-allergic) and 10 non-asthmatic controls will be enrolled to this study to collect exhaled breathe condensates (EBC) and measure levels of inflammatory cytokines in EBC
Key inclusion criteria (3 listed)
- Have been diagnosed as asthma at least 6 months before enrolled to the study
- Known skin prick test results to aeroallergens ; either positive or negative
- 15-65 years of age
Key exclusion criteria (4 listed)
- On oral or inhaled corticosteroids within 1 month before the study
- Having asthma exacerbation
- Being pregnant
- Suffering from severe systemic disease/ in bad health
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
Levels of inflammatory cytokines in exhaled breathe condensates
Time frame: 4 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 23 Nov 2010.
- Derived from this study: PubMed 23998235Boonpiyathad S, Pornsuriyasak P, Buranapraditkun S, Klaewsongkram J. Interleukin-2 levels in exhaled breath condensates, asthma severity, and asthma control in nonallergic asthma. Allergy Asthma Proc. 2013 Sep-Oct;34(5):e35-41. doi: 10.2500/aap.2013.34.3680.
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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.
Jettanong Klaewsongkram, MD principal investigator
Chulalongkorn University
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, run by Chulalongkorn University at 1 site in Thailand.
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 3 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 23 Nov 2010. 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 Thailand. 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?
Levels of inflammatory cytokines in exhaled breathe condensates (time frame: 4 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 NCT01246414, 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 23 Nov 2010.