NCT02902471

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

July 16, 2018

Status Verified

April 1, 2017

Enrollment Period

4.3 years

First QC Date

September 12, 2016

Last Update Submit

July 13, 2018

Conditions

Bronchiolitis ObliteransBone Marrow Transplantation

Outcome Measures

Primary Outcomes (1)

  • Number of days

    Temporal difference between the date of the functional change measured by the technique of the forced oscillations and by the standard techniques of plethysmography.

    2 years

Study Arms (1)

Group A

EXPERIMENTAL

Patients with bronchiolitis obliterans syndrome after bone marrow transplantation

Other: Forced oscillations measure

Interventions

Forced oscillations measureOTHER
Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Lille

Lille, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (20)

  • 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.

    PMID: 19602690BACKGROUND

  • 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.

    PMID: 17470622BACKGROUND

  • 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.

    PMID: 12649126BACKGROUND

  • 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.

    PMID: 17351647BACKGROUND

  • 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.

    PMID: 19204468BACKGROUND

  • 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.

    PMID: 16635784BACKGROUND

  • 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.

    PMID: 19421092BACKGROUND

  • 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.

    PMID: 16364161BACKGROUND

  • 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.

    PMID: 14680096BACKGROUND

  • 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

    BACKGROUND

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

    PMID: 11603948BACKGROUND

  • 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.

    PMID: 20204806BACKGROUND

  • 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.

    PMID: 19781078BACKGROUND

  • 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.

    PMID: 3826883BACKGROUND

  • 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.

    PMID: 15078731BACKGROUND

  • 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.

    PMID: 16115754BACKGROUND

  • 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.

    PMID: 20045997BACKGROUND

  • 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.

    PMID: 16713226BACKGROUND

  • 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.

    PMID: 11590906BACKGROUND

  • 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.

    PMID: 18760576BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Jean-Louis Couderc, MD, PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

June 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 16, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)