Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation

Lung Disease Clinical Trial

— DLNO/DLCO  

Official title:

Changes in Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Allogeneic Versus Autologous Hematopoietic Stem-cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735526
• Other study ID #: 33/2012
• Status: Completed
• Phase: N/A
• First received: November 24, 2012
• Last updated: September 21, 2014
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be hypothesized that these changes might be due to an occult intersitial lung disease associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or any combination of these. To test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO and estimate the changes of membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) by the DLNO/DLCO ratio. As we hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with those of subjects undergoing allo-HSCT.

Description:

In allogeneic hematopoietic stem-cell transplantation (allo-HSCT) recipients, early reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS)[PMID: 22221781]. Two months after allo-HSCT, we have recently shown an increase in lung tissue density determined by quantitative CT scan [PMID: 22898044]. It can be hypothesized that these parenchymal changes might be due to an occult intersitial lung disease associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or any combination of these [PMID: 21531955]. To test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO. Assuming, for clinical purposes, that the reaction rate of NO with blood hemoglobin is infinite so that DLNO = DMNO = DMCO*alpha (alpha = NO/CO diffusivity ratio), as to partition the effect of HSCT on membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) we will use the DLNO/DLCO ratio [PMID:16478855]. As we hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with those of subjects undergoing allo-HSCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• baseline spirometry, lung volumes, and DLCO of the subjects included in the analysis must be within the predicted normal range

• all patients must be in stable clinical conditions at the time of study

Exclusion Criteria:

• a history of bronchial asthma, chronic obstructive pulmonary disease, or other significant respiratory disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Bacigalupo A, Chien J, Barisione G, Pavletic S. Late pulmonary complications after allogeneic hematopoietic stem cell transplantation: diagnosis, monitoring, prevention, and treatment. Semin Hematol. 2012 Jan;49(1):15-24. doi: 10.1053/j.seminhematol.2011.10.005. Review. — View Citation

Barisione G, Pompilio PP, Bacigalupo A, Brusasco C, Cioè A, Dellacà RL, Lamparelli T, Garlaschi A, Pellegrino R, Brusasco V. Airway distensibility with lung inflation after allogeneic haematopoietic stem-cell transplantation. Respir Physiol Neurobiol. 2012 Oct 15;184(1):80-5. doi: 10.1016/j.resp.2012.07.021. Epub 2012 Aug 8. — View Citation

Panoskaltsis-Mortari A, Griese M, Madtes DK, Belperio JA, Haddad IY, Folz RJ, Cooke KR; American Thoracic Society Committee on Idiopathic Pneumonia Syndrome. An official American Thoracic Society research statement: noninfectious lung injury after hematopoietic stem cell transplantation: idiopathic pneumonia syndrome. Am J Respir Crit Care Med. 2011 May 1;183(9):1262-79. doi: 10.1164/rccm.2007-413ST. Review. — View Citation

van der Lee I, Zanen P, Grutters JC, Snijder RJ, van den Bosch JM. Diffusing capacity for nitric oxide and carbon monoxide in patients with diffuse parenchymal lung disease and pulmonary arterial hypertension. Chest. 2006 Feb;129(2):378-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in DLNO/DLCO ratio after allo- versus autologous HSCT		Before and 2-6 months after HSCT	No
Secondary	Changes in lung tissue density after allo- versus autologous HSCT		Before and 2-6 months after HSCT	No