LVR in Severe Emphysema Using Bronchoscopic Autologous Blood Instillation in Combination With Intra-bronchial Valves

NCT03010449 | Unknown DMC

• 1 other identifier: 135459
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A single arm pilot study of lung volume reduction in severe emphysema using bronchoscopic autologous blood instillation in combination with intra-bronchial valves.

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema

Keywords

Lung volume reduction treatment; Autologous blood instillation; Intra-bronchial valve (IBV); Endobronchial valve

Outcome Measures

Primary Outcomes (1)

• Change in FEV1 between baseline and 6 months follow-up after lung volume reduction treatment.

  6 months

Secondary Outcomes (9)

• Change from baseline in CT lobar volumes 6 months post treatment

  6 months

• Change from baseline in SGRQ 6 months post treatment

  6 months

• Change from baseline in dyspnoea score 6 months post treatment

  6 months

• Change from baseline in RV 6 months post treatment

  6 months

• Change from baseline in TLC 6 months post treatment

  6 months

Study Arms (1)

Intra-bronchial valve and blood

EXPERIMENTAL

Bronchoscopic lung volume reduction using intra-bronchial valves combined with autologous blood instillation.

Device: Intra-bronchial valve and blood

Interventions

Intra-bronchial valve and blood DEVICE

Intra-bronchial valve implantation in combination with autologous blood instillation

Intra-bronchial valve and blood

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 or older
• Diagnosis of severe COPD
• Stopped smoking for at least 6 months prior to entering the study.
• Completed a pulmonary rehabilitation program within 12 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 12 months prior to baseline testing.
• Received Influenza vaccination consistent with local recommendations and/or policy.
• Read, understood and signed the Informed Consent form.
• Dyspnea scoring ≥2 on mMRC scale of 0-4.
• FEV1%pred \<45% and FEV1/FVC \<60%.
• TLC%pred \>100% AND RV%pred \>175%.
• RV/TLC \>55%
• CT thorax must demonstrate heterogeneous emphysema and a disrupted interlobar fissure (75-90% intact) in the treatment lobe. Scans will be analysed using in-house software to calculate a heterogeneity score and percentage fissure integrity.
• Chartis balloon catheter assessment confirms the presence of collateral ventilation in the target lobe.

You may not qualify if:

• Patient unable to provide informed consent.
• Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment.
• Subject has clinically significant bronchiectasis.
• Alpha-1 AT deficiency.
• Medical history of asthma.
• Subject has co-morbidities that may significantly reduce ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnoea.
• Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
• Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
• Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
• Subject has severe gas exchange abnormalities as defined by: PaCO2 \>8.0 kPa and/or PaO2 \< 6.0 kPa (on room air).
• FEV1 \<15% predicted and Total lung CO uptake (TLCO) \<20% predicted.
• Subject has an inability to walk \>140 meters in 6 minutes.
• Subject has severe pulmonary hypertension defined by right ventricular systolic pressure \>45 mm Hg measured on transthoracic echocardiogram.
• Subject has giant bullae \>1/3 lung volume.
• Lung nodule requiring surgery.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefields Hospital

London, SW3 6NP, United Kingdom

RECRUITING

Related Publications (19)

• Coxson HO, Nasute Fauerbach PV, Storness-Bliss C, Muller NL, Cogswell S, Dillard DH, Finger CL, Springmeyer SC. Computed tomography assessment of lung volume changes after bronchial valve treatment. Eur Respir J. 2008 Dec;32(6):1443-50. doi: 10.1183/09031936.00056008. Epub 2008 Aug 6.

  PMID: 18684848 RESULT

• Springmeyer SC, Bolliger CT, Waddell TK, Gonzalez X, Wood DE; IBV Valve Pilot Trials Research Teams. Treatment of heterogeneous emphysema using the spiration IBV valves. Thorac Surg Clin. 2009 May;19(2):247-53, ix-x. doi: 10.1016/j.thorsurg.2009.02.005.

  PMID: 19662968 RESULT

• Sterman DH, Mehta AC, Wood DE, Mathur PN, McKenna RJ Jr, Ost DE, Truwit JD, Diaz P, Wahidi MM, Cerfolio R, Maxfield R, Musani AI, Gildea T, Sheski F, Machuzak M, Haas AR, Gonzalez HX, Springmeyer SC; IBV Valve US Pilot Trial Research Team. A multicenter pilot study of a bronchial valve for the treatment of severe emphysema. Respiration. 2010;79(3):222-33. doi: 10.1159/000259318. Epub 2009 Nov 17.

  PMID: 19923790 RESULT

• Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012 Jun;39(6):1319-25. doi: 10.1183/09031936.00019711.

  PMID: 22654006 RESULT

• Eberhardt R, Gompelmann D, Schuhmann M, Reinhardt H, Ernst A, Heussel CP, Herth FJF. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908. doi: 10.1378/chest.11-2886.

  PMID: 22459779 RESULT

• Franke KJ, Nilius G, Domanski U, Ruhle KH. [Unilateral reduction of lung volume by application of intrabronchial valves on patients selected after endoscopic collateral ventilation assessment]. Pneumologie. 2014 Feb;68(2):100-5. doi: 10.1055/s-0033-1359025. Epub 2013 Dec 16. German.

  PMID: 24343242 RESULT

• Perch M, Riise GC, Hogarth K, Musani AI, Springmeyer SC, Gonzalez X, Iversen M. Endoscopic treatment of native lung hyperinflation using endobronchial valves in single-lung transplant patients: a multinational experience. Clin Respir J. 2015 Jan;9(1):104-10. doi: 10.1111/crj.12116. Epub 2014 Apr 15.

  PMID: 24506317 RESULT

• Wood DE, Nader DA, Springmeyer SC, Elstad MR, Coxson HO, Chan A, Rai NS, Mularski RA, Cooper CB, Wise RA, Jones PW, Mehta AC, Gonzalez X, Sterman DH; IBV Valve Trial Research Team. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014 Oct;21(4):288-97. doi: 10.1097/LBR.0000000000000110.

  PMID: 25321447 RESULT

• Szlubowska S, Zalewska-Puchala J, Majda A, Kocon P, Soja J, Gnass M, Pasko E, Cmiel A, Szlubowski A, Kuzdzal J. The influence of lung volume reduction with intrabronchial valves on the quality of life of patients with heterogeneous emphysema - a prospective study. Pneumonol Alergol Pol. 2015;83(6):418-23. doi: 10.5603/PiAP.2015.0069.

  PMID: 26559793 RESULT

• Snell GI, Holsworth L, Borrill ZL, Thomson KR, Kalff V, Smith JA, Williams TJ. The potential for bronchoscopic lung volume reduction using bronchial prostheses: a pilot study. Chest. 2003 Sep;124(3):1073-80. doi: 10.1378/chest.124.3.1073.

  PMID: 12970040 RESULT

• Toma TP, Hopkinson NS, Hillier J, Hansell DM, Morgan C, Goldstraw PG, Polkey MI, Geddes DM. Bronchoscopic volume reduction with valve implants in patients with severe emphysema. Lancet. 2003 Mar 15;361(9361):931-3. doi: 10.1016/S0140-6736(03)12762-6.

  PMID: 12648974 RESULT

• Koster TD, Slebos DJ. The fissure: interlobar collateral ventilation and implications for endoscopic therapy in emphysema. Int J Chron Obstruct Pulmon Dis. 2016 Apr 13;11:765-73. doi: 10.2147/COPD.S103807. eCollection 2016.

  PMID: 27110109 RESULT

• Ingenito EP, Reilly JJ, Mentzer SJ, Swanson SJ, Vin R, Keuhn H, Berger RL, Hoffman A. Bronchoscopic volume reduction: a safe and effective alternative to surgical therapy for emphysema. Am J Respir Crit Care Med. 2001 Jul 15;164(2):295-301. doi: 10.1164/ajrccm.164.2.2011085.

  PMID: 11463604 RESULT

• Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.

  PMID: 12406835 RESULT

• Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.

  PMID: 17426216 RESULT

• Criner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29.

  PMID: 19179484 RESULT

• Bakeer M, Abdelgawad TT, El-Metwaly R, El-Morsi A, El-Badrawy MK, El-Sharawy S. Low cost biological lung volume reduction therapy for advanced emphysema. Int J Chron Obstruct Pulmon Dis. 2016 Aug 3;11:1793-800. doi: 10.2147/COPD.S112009. eCollection 2016.

  PMID: 27536091 RESULT

• Refaely Y, Dransfield M, Kramer MR, Gotfried M, Leeds W, McLennan G, Tewari S, Krasna M, Criner GJ. Biologic lung volume reduction therapy for advanced homogeneous emphysema. Eur Respir J. 2010 Jul;36(1):20-7. doi: 10.1183/09031936.00106009. Epub 2009 Nov 19.

  PMID: 19926742 RESULT

• Lopes AJ, Mafort TT. Correlations between small airway function, ventilation distribution, and functional exercise capacity in COPD patients. Lung. 2014 Oct;192(5):653-9. doi: 10.1007/s00408-014-9626-1. Epub 2014 Jul 22.

  PMID: 25047513 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pallav L Shah, MBBS MD FRCP

  Royal Brompton & Harefields Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin L Garner, MBBS MRCP

CONTACT

02073518029; J.Garner@rbht.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: August 24, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)