NCT02064686

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

6 years

First QC Date

February 14, 2014

Last Update Submit

February 17, 2014

Conditions

ASTHMA

Outcome Measures

Primary Outcomes (1)

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

    4 years

Study Arms (1)

TAE

NO INTERVENTION
Other: Exhaled breath temperature

Interventions

Exhaled breath temperatureOTHER
TAE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with asthma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Sta. Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

Related Publications (4)

  • 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.

    PMID: 11790651BACKGROUND

  • 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.

    PMID: 12166556BACKGROUND

  • 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.

    PMID: 15705206BACKGROUND

  • 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.

    PMID: 17624752BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jordi Giner, MSc

    Hospital de la Sta. Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Giner, MSc

CONTACT

0034666291236jginer@santpau.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

April 1, 2009

Primary Completion

April 1, 2015

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

ES(1)