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Metabolomic Analysis of Exhaled Breath Condensate in Asthmatics

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ClinicalTrials.gov Identifier: NCT01439737
Recruitment Status : Unknown
Verified September 2011 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the clinical manifestations and treatment responses in these patients. 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. Up to now, few studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic evaluation of airway disorders. 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. This study will apply metabolomics to examine the biomarkers in the EBCs, serum and urine specimens in adult asthmatics.

Condition or disease
Asthma

Detailed Description:
The aims of this study are: 1. Metabolomic profiling of the exhaled breath condensate (EBC), serum and urine specimens in adult asthmatics; 2. Correlation between metabolomic profiles of these specimens with the severity and control of asthma; 3. Comparing metabolomic profiles in asthmatics with different phenotypes and endotypes; 4.Comparing metabolomic profiles obtained from asthmatics during stable and acute exacerbation periods; 5. Comparing metabolomic profiles in asthmatics before and after inhaled corticosteroid therapy.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolomic Analysis of Exhaled Breath Condensate, Plasma and Urine Specimens in Adult Asthmatics
Study Start Date : September 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort
asthma



Biospecimen Retention:   Samples Without DNA
Exhaled breath condensates, serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult asthmatics
Criteria

Inclusion Criteria:

  1. 20-90 years
  2. Diagnosis of asthma based on the GINA guideline

Exclusion Criteria:

  1. Patient with cancer
  2. Patient with long-term ventilator use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439737


Contacts
Contact: Ping-Hung Kuo kph712@ntuh.gov.tw

Locations
Taiwan
Department of Internal Medicine, National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Cindy Yu, B.S>    886-2-23562905    cindy07_13@hotmail.com   
Principal Investigator: Ping-Hung Kuo, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ping-Hung Kuo National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01439737     History of Changes
Other Study ID Numbers: 201108051RC
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by National Taiwan University Hospital:
Asthma
metabolomics
exhaled breath condensate