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Exhaled Air Temperature (TAE) As A Marker Of Airway Inflammation In Asthma

F

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Unknown

Conditions

ASTHMA

Treatments

Other: Exhaled breath temperature

Study type

Interventional

Funder types

Other

Identifiers

NCT02064686
09/078/992
IIBSP-TAE-2011-145

Details and patient eligibility

About

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 .

  1. 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.

Full 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 .

  1. 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with asthma

Exclusion criteria

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

150 participants in 1 patient group

TAE
No Intervention group
Treatment:
Other: Exhaled breath temperature

Trial contacts and locations

1

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Central trial contact

Jordi Giner, MSc

Data sourced from clinicaltrials.gov

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