Exhaled Air Temperature (TAE) As A Marker Of Airway Infla... | NCT02064686

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

NCT02064686

Sponsor

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

Status

Unknown status

Last Update Posted

Feb 19, 2014Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

ASTHMA

Interventions

Exhaled breath temperature

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
09/078/992

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2015Estimated

Completion Date

Not provided

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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 .

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
TAE	No Intervention		Other: Exhaled breath temperature

Name	Type	Description	Arm Group Labels	Other Names
Exhaled breath temperature	Other		TAE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exhaled Breath Temperature (TAE) As A Marker Of Airway Inflammation In Asthma		4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with asthma

Exclusion Criteria:

Patients unable to perform the maneuver the measurement of the TAE

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jordi Giner, MSc	Contact	0034666291236		jginer@santpau.cat

Overall Officials

Name	Affiliation	Role
Jordi Giner, MSc	Hospital de la Sta. Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Sta. Creu i Sant Pau	Recruiting	Barcelona	Catalonia	08025	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11790651	Background	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.
12166556	Background	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases