Exhaled Air Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
Primary Purpose
ASTHMA
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exhaled breath temperature
Sponsored by
About this trial
This is an interventional screening trial for ASTHMA
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with asthma
Exclusion Criteria:
- Patients unable to perform the maneuver the measurement of the TAE
Sites / Locations
- Hospital de la Sta. Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
TAE
Arm Description
Outcomes
Primary Outcome Measures
Exhaled Breath Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
Secondary Outcome Measures
Full Information
NCT ID
NCT02064686
First Posted
February 14, 2014
Last Updated
February 17, 2014
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT02064686
Brief Title
Exhaled Air Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
Official Title
EXHALED AIR TEMPERATURE (TAE) AS A MARKER OF AIRWAY INFLAMMATION IN ASTHMA
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goals : to develop and computerize equipment for measuring ITAE , compare the results with TAEP Itae study the possible relationship between different markers of inflammation: sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a bronchodilator in measuring the ITAE .
It has designed a line of work studying the following aspects :
1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30 asthma and 30 volunteers .
Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.
Three . ITAE measurement before and after the spirometry test , 20 patients , in stable phase will be measured before and after the ITAE spirometry .
April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol , 20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen minutes after administration of salbutamol .
May . Measurement in patients Itae a bronchial provocation test with methacholine was performed , 20 patients were measured and baseline Itae after administration of methacholine .
6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients during an exacerbation , the ITAE be measured. Already in clinically stable measurement is repeated.
Detailed Description
The goals : to develop and computerize equipment for measuring ITAE , compare the results with TAEP Itae study the possible relationship between different markers of inflammation: sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a bronchodilator in measuring the ITAE .
It has designed a line of work studying the following aspects :
1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30 asthma and 30 volunteers .
Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.
Three . ITAE measurement before and after the spirometry test , 20 patients , in stable phase will be measured before and after the ITAE spirometry .
April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol , 20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen minutes after administration of salbutamol .
May . Measurement in patients Itae a bronchial provocation test with methacholine was performed , 20 patients were measured and baseline Itae after administration of methacholine .
6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients during an exacerbation , the ITAE be measured. Already in clinically stable measurement is repeated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ASTHMA
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAE
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Exhaled breath temperature
Primary Outcome Measure Information:
Title
Exhaled Breath Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with asthma
Exclusion Criteria:
Patients unable to perform the maneuver the measurement of the TAE
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Giner, MSc
Phone
0034666291236
Email
jginer@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Giner, MSc
Organizational Affiliation
Hospital de la Sta. Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Sta. Creu i Sant Pau
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Giner, MSc
Phone
0034666291236
Email
jginer@santpau.cat
First Name & Middle Initial & Last Name & Degree
Jordi Giner, MSc
First Name & Middle Initial & Last Name & Degree
Astrid Crespo, MD
First Name & Middle Initial & Last Name & Degree
Alfons Torrego, MD
First Name & Middle Initial & Last Name & Degree
Montse Torrejón, MSc
First Name & Middle Initial & Last Name & Degree
Vicente Plaza, MDPhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
11790651
Citation
Paredi P, Kharitonov SA, Barnes PJ. Faster rise of exhaled breath temperature in asthma: a novel marker of airway inflammation? Am J Respir Crit Care Med. 2002 Jan 15;165(2):181-4. doi: 10.1164/ajrccm.165.2.2103053.
Results Reference
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PubMed Identifier
12166556
Citation
Piacentini GL, Bodini A, Zerman L, Costella S, Zanolla L, Peroni DG, Boner AL. Relationship between exhaled air temperature and exhaled nitric oxide in childhood asthma. Eur Respir J. 2002 Jul;20(1):108-11. doi: 10.1183/09031936.02.00237702.
Results Reference
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PubMed Identifier
15705206
Citation
Paredi P, Kharitonov SA, Barnes PJ. Correlation of exhaled breath temperature with bronchial blood flow in asthma. Respir Res. 2005 Feb 10;6(1):15. doi: 10.1186/1465-9921-6-15.
Results Reference
background
PubMed Identifier
17624752
Citation
Popov TA, Dunev S, Kralimarkova TZ, Kraeva S, DuBuske LM. Evaluation of a simple, potentially individual device for exhaled breath temperature measurement. Respir Med. 2007 Oct;101(10):2044-50. doi: 10.1016/j.rmed.2007.06.005. Epub 2007 Jul 12.
Results Reference
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Exhaled Air Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
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