"Exhaled Breath Condensate" in Allogeneic Stem Cell Recipients and the Value in Follow-up

Exhaled Breath Condensate Clinical Trial

Official title:

"Exhaled Breath Condensate" in Allogeneic Stem Cell Recipients and Value in Follow-up

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02318316
• Other study ID #: EBC01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2014
• Last updated: December 16, 2014
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: December 2014
• Source: Gazi University
• Contact: Nilgün Yilmaz Demirci, MD
• Phone: 009031224143
• Email: nilgundemirci[@]gazi.edu.tr
• Is FDA regulated: No
• Health authority: Gazi University: Ankara Turkey
• Study type: Observational

Clinical Trial Summary

The most effective treatment of hematologic malignancies and some benign hematological diseases is allogeneic stem cell transplantation therapy. Pulmonary complications can occur after allogeneic stem cell transplantation. And these complications effect mortality and morbidity in these patients. In this study we want to investigate the use of exhaled breath condensate (EBC) collection which is a simple and completely noninvasive method. By this way we hope to detect pulmonary complications early. EBC, has been implicated in the pathophysiology of inflammatory airway diseases such as cystic fibrosis, asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. EBC, has not been investigated before in patients who underwent stem cell transplantation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• hematologic malignancies or benign hematological diseases that allogeneic stem cell transplantation performed

Exclusion Criteria:

• allogeneic stem cell transplantation patients with Asthma or COPD

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exhaled Breath Condensate

Intervention

Other:
• Exhaled breath condensate
Breath condensate samples will be collected with a commercially available condenser (EcoScreen®, Erich Jaeger, Germany). Subjects will breathe through a mouthpiece and a two-way non-rebreathing value in which inspiratory and expiratory air were separated, and saliva was trapped. They will be asked to breathe at a normal frequency and tidal volume for 15 minutes while wearing nose clips, allowing collection of 1.5-2.5 mL of condensate. After collecting this, pH will be measured and the waste collection will be stored at -80 degrees. Then 8 isoprostane and nitrotyrosine will be measured collectively

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gazi University	Tubitak

References & Publications (3)

Dupont LJ, Dewandeleer Y, Vanaudenaerde BM, Van Raemdonck DE, Verleden GM. The pH of exhaled breath condensate of patients with allograft rejection after lung transplantation. Am J Transplant. 2006 Jun;6(6):1486-92. — View Citation

Horváth I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jöbsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. — View Citation

Mo XD, Xu LP, Liu DH, Zhang XH, Chen H, Chen YH, Han W, Wang Y, Wang FR, Wang JZ, Liu KY, Huang XJ. Risk factors for bronchiolitis obliterans syndrome in allogeneic hematopoietic stem cell transplantation. Chin Med J (Engl). 2013 Jul;126(13):2489-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pH level of exhaled breath condansate		2 years	No
Secondary	The nitrotyrosine and 8-isoprostane levels of exhaled breath condansate		2 years	No