Clinical trial NCT02064686: 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
Overall status: UNKNOWN
Phase: NA
Conditions: ASTHMA
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with asthma

Exclusion Criteria:

* Patients unable to perform the maneuver the measurement of the TAE

Primary outcomes:
measure: Exhaled Breath Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Sta. Creu i Sant Pau
state: Catalunya
Study officials:
affiliation: Hospital de la Sta. Creu i Sant Pau
name: Jordi Giner, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.