- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02064686
Exhaled Air Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
EXHALED AIR TEMPERATURE (TAE) AS A MARKER OF AIRWAY INFLAMMATION IN ASTHMA
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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Catalunya
-
Barcelona, Catalunya, Spagna, 08025
- Reclutamento
- Hospital de la Sta. Creu i Sant Pau
-
Contatto:
- Jordi Giner, MSc
- Numero di telefono: 0034666291236
- Email: jginer@santpau.cat
-
Investigatore principale:
- Jordi Giner, MSc
-
Sub-investigatore:
- Astrid Crespo, MD
-
Sub-investigatore:
- Alfons Torrego, MD
-
Sub-investigatore:
- Montse Torrejón, MSc
-
Sub-investigatore:
- Vicente Plaza, MDPhD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients diagnosed with asthma
Exclusion Criteria:
- Patients unable to perform the maneuver the measurement of the TAE
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: TAE
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Exhaled Breath Temperature (TAE) As A Marker Of Airway Inflammation In Asthma
Lasso di tempo: 4 years
|
4 years
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Jordi Giner, MSc, Hospital de la Sta. Creu i Sant Pau
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIBSP-TAE-2011-145
- 09/078/992
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Exhaled breath temperature
-
The Hong Kong Polytechnic UniversitySEED Co. Ltd.CompletatoMiopia | OrtocheratologiaHong Kong
-
Radboud University Medical CenterDutch Digestive Diseases FoundationCompletatoCancro esofageo | Esofago di BarrettOlanda
-
Menssana Research, Inc.National Heart, Lung, and Blood Institute (NHLBI)SconosciutoRigetto del trapianto di cuoreStati Uniti
-
The Hong Kong Polytechnic UniversitySEED Co. Ltd.Completato
-
University of ZurichReclutamentoRigetto cronico del trapianto di polmoneSvizzera
-
VenterPharmaCompletato
-
Universitaire Ziekenhuizen KU LeuvenCompletato
-
Royal Brisbane and Women's HospitalCompletato
-
Peking Union Medical College HospitalReclutamentoCancro al seno | Tecnologia di monitoraggio della superficie ottica | Radioterapia ad ampio segmentoCina
-
University Hospital, BonnCompletatoSindromi da malassorbimentoGermania