Forced Oscillations for Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation

NCT ID: NCT02902471

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-09-30

Brief Summary

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A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans syndrome in patients after bone marrow transplantation. The force oscillations technique will be compared with classical spirometry.

Detailed Description

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Conditions

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Bronchiolitis Obliterans Bone Marrow Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group A

Patients with bronchiolitis obliterans syndrome after bone marrow transplantation

Group Type EXPERIMENTAL

Forced oscillations measure

Intervention Type OTHER

Interventions

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Forced oscillations measure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years
* Bone marrow or hematopoietic stem cells transplantation for more than 100 days
* Clinical stability
* Patients affiliated to a social security system
* Patients having given his (her) written consent.

Exclusion Criteria

* Bronchiolitis Obliterans already diagnosed
* Unresolved Respiratory infection
* Unresolved mechanical complication (pneumothorax, effusions)
* Medicinal pneumopathy
* Inability to perform pulmonary function tests
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis Couderc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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CHRU de Lille

Lille, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018.

Reference Type BACKGROUND
PMID: 19602690 (View on PubMed)

Soubani AO, Uberti JP. Bronchiolitis obliterans following haematopoietic stem cell transplantation. Eur Respir J. 2007 May;29(5):1007-19. doi: 10.1183/09031936.00052806.

Reference Type BACKGROUND
PMID: 17470622 (View on PubMed)

Chien JW, Martin PJ, Gooley TA, Flowers ME, Heckbert SR, Nichols WG, Clark JG. Airflow obstruction after myeloablative allogeneic hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2003 Jul 15;168(2):208-14. doi: 10.1164/rccm.200212-1468OC. Epub 2003 Mar 20.

Reference Type BACKGROUND
PMID: 12649126 (View on PubMed)

Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socie G, Tazi A. Combined inhaled steroids and bronchodilatators in obstructive airway disease after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 May;39(9):547-53. doi: 10.1038/sj.bmt.1705637. Epub 2007 Mar 12.

Reference Type BACKGROUND
PMID: 17351647 (View on PubMed)

Gunn ML, Godwin JD, Kanne JP, Flowers ME, Chien JW. High-resolution CT findings of bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation. J Thorac Imaging. 2008 Nov;23(4):244-50. doi: 10.1097/RTI.0b013e3181809df0.

Reference Type BACKGROUND
PMID: 19204468 (View on PubMed)

Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD, Foley R, Socie G, Carter S, Couriel D, Schultz KR, Flowers ME, Filipovich AH, Saliba R, Vogelsang GB, Pavletic SZ, Lee SJ; Design of Clinical Trials Working Group. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant. 2006 May;12(5):491-505. doi: 10.1016/j.bbmt.2006.03.004.

Reference Type BACKGROUND
PMID: 16635784 (View on PubMed)

Garcia G, Perez T, Mahut B. [Lung function testing and assessment of distal airways in asthma]. Rev Mal Respir. 2009 Apr;26(4):395-406; quiz 479, 482. doi: 10.1016/s0761-8425(09)74044-6. French.

Reference Type BACKGROUND
PMID: 19421092 (View on PubMed)

Bourdin A, Paganin F, Prefaut C, Kieseler D, Godard P, Chanez P. Nitrogen washout slope in poorly controlled asthma. Allergy. 2006 Jan;61(1):85-9. doi: 10.1111/j.1398-9995.2006.00970.x.

Reference Type BACKGROUND
PMID: 16364161 (View on PubMed)

Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.

Reference Type BACKGROUND
PMID: 14680096 (View on PubMed)

Smith HJ, Reinhold P, Goldman MD. Forced Oscillation Technique and Impulse Oscillometry. Lung Function Testing: European Respiratory Society Monograph. Sheffield, England: European Respiratory Society; 2005:72-105

Reference Type BACKGROUND

Goldman MD. Clinical application of forced oscillation. Pulm Pharmacol Ther. 2001;14(5):341-50. doi: 10.1006/pupt.2001.0310.

Reference Type BACKGROUND
PMID: 11603948 (View on PubMed)

Hamakawa H, Sakai H, Takahashi A, Zhang J, Okamoto T, Satoda N, Aoyama A, Chen F, Fujinaga T, Shoji T, Bando T, Mishima M, Wada H, Date H. Forced oscillation technique as a non-invasive assessment for lung transplant recipients. Adv Exp Med Biol. 2010;662:293-8. doi: 10.1007/978-1-4419-1241-1_42.

Reference Type BACKGROUND
PMID: 20204806 (View on PubMed)

Faria AC, Lopes AJ, Jansen JM, Melo PL. Evaluating the forced oscillation technique in the detection of early smoking-induced respiratory changes. Biomed Eng Online. 2009 Sep 25;8:22. doi: 10.1186/1475-925X-8-22.

Reference Type BACKGROUND
PMID: 19781078 (View on PubMed)

Brochard L, Pelle G, de Palmas J, Brochard P, Carre A, Lorino H, Harf A. Density and frequency dependence of resistance in early airway obstruction. Am Rev Respir Dis. 1987 Mar;135(3):579-84. doi: 10.1164/arrd.1987.135.3.579.

Reference Type BACKGROUND
PMID: 3826883 (View on PubMed)

Skloot G, Goldman M, Fischler D, Goldman C, Schechter C, Levin S, Teirstein A. Respiratory symptoms and physiologic assessment of ironworkers at the World Trade Center disaster site. Chest. 2004 Apr;125(4):1248-55. doi: 10.1378/chest.125.4.1248.

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Di Mango AM, Lopes AJ, Jansen JM, Melo PL. Changes in respiratory mechanics with increasing degrees of airway obstruction in COPD: detection by forced oscillation technique. Respir Med. 2006 Mar;100(3):399-410. doi: 10.1016/j.rmed.2005.07.005. Epub 2005 Aug 22.

Reference Type BACKGROUND
PMID: 16115754 (View on PubMed)

Kanda S, Fujimoto K, Komatsu Y, Yasuo M, Hanaoka M, Kubo K. Evaluation of respiratory impedance in asthma and COPD by an impulse oscillation system. Intern Med. 2010;49(1):23-30. doi: 10.2169/internalmedicine.49.2191. Epub 2010 Jan 1.

Reference Type BACKGROUND
PMID: 20045997 (View on PubMed)

Cavalcanti JV, Lopes AJ, Jansen JM, Melo PL. Detection of changes in respiratory mechanics due to increasing degrees of airway obstruction in asthma by the forced oscillation technique. Respir Med. 2006 Dec;100(12):2207-19. doi: 10.1016/j.rmed.2006.03.009. Epub 2006 May 18.

Reference Type BACKGROUND
PMID: 16713226 (View on PubMed)

Kim CW, Kim JS, Park JW, Hong CS. Clinical applications of forced oscillation techniques (FOT) in patients with bronchial asthma. Korean J Intern Med. 2001 Jun;16(2):80-6. doi: 10.3904/kjim.2001.16.2.80.

Reference Type BACKGROUND
PMID: 11590906 (View on PubMed)

Kolsum U, Borrill Z, Roy K, Starkey C, Vestbo J, Houghton C, Singh D. Impulse oscillometry in COPD: identification of measurements related to airway obstruction, airway conductance and lung volumes. Respir Med. 2009 Jan;103(1):136-43. doi: 10.1016/j.rmed.2008.07.014. Epub 2008 Aug 28.

Reference Type BACKGROUND
PMID: 18760576 (View on PubMed)

Other Identifiers

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2010-A01229-30

Identifier Type: OTHER

Identifier Source: secondary_id

2010/48

Identifier Type: -

Identifier Source: org_study_id

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