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Metabolomic Analysis of Exhaled Breath Condensate in Asthmatics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439737
First Posted: September 23, 2011
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolomic Analysis of Exhaled Breath Condensate, Plasma and Urine Specimens in Adult Asthmatics

Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01439737     History of Changes
Other Study ID Numbers: 201108051RC
First Submitted: September 21, 2011
First Posted: September 23, 2011
Last Update Posted: September 23, 2011
Last Verified: September 2011

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