Study Results
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Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2016-09-30
2019-11-20
Brief Summary
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This is a Phase II, pilot randomized double blind control study, meaning this study will help assess if this research can be expanded to evaluate Ig treatment in patients with COPD. Ig treatment is a sterile solution of human immunoglobulin proteins given intravenously (in the vein). Immunoglobulins are part of the immune system and help the body fight infections. Participants will be assigned to either receiving the Ig treatment or normal saline as a control product every 4 weeks for 12 months.
Participants will continue on current standard therapy as determined by their treating physician.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Intervention Arm 1: Treatment
Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
Intravenous immunoglobulin (IVIG)
Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization.
Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization
Intervention Arm 2: Control
Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).
Normal Saline
Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization.
Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization
Interventions
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Intravenous immunoglobulin (IVIG)
Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization.
Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization
Normal Saline
Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization.
Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of severe COPD (post bronchodilator FEV1 \<50%, FEV1/FVC ratio \<0.7) made by standard spirometry within previous 12 months or within three days of admission if previous PFT data is not available
* Age \>40 years
* \>10 pack year smoking history
* At least one COPD exacerbation in the previous 12 months before enrollment, defined by having had documented inpatient or outpatient treatment by physician with antibiotics and/or prednisone for physician diagnosed COPD exacerbation
* Expected to live \> 12 months
Exclusion Criteria
* Underlying malignancy (including chronic lymphocytic leukemia)
* History of hematopoietic stem cell transplant or solid organ transplant
* Current treatment with a biological therapy for other conditions
* Concomitant significant immunodeficiency or on immunosuppressive treatment other than for COPD
* Alpha-1 antitrypsin deficiency
* Significant proteinuria (dipstick proteinuria ≥ 3+ or known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis)
* IgA deficiency (IgA \<0.1 g/L)
* Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html)
* Obesity (BMI ≥35 kg/m²)
* Pregnancy
40 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Grifols Biologicals, LLC
INDUSTRY
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Juthaporn Cowan, MD, PhD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Associate Scientist
Locations
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The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Countries
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References
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Toy EL, Gallagher KF, Stanley EL, Swensen AR, Duh MS. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010 Jun;7(3):214-28. doi: 10.3109/15412555.2010.481697.
Mullerova H, Maselli DJ, Locantore N, Vestbo J, Hurst JR, Wedzicha JA, Bakke P, Agusti A, Anzueto A. Hospitalized exacerbations of COPD: risk factors and outcomes in the ECLIPSE cohort. Chest. 2015 Apr;147(4):999-1007. doi: 10.1378/chest.14-0655.
Baker CL, Zou KH, Su J. Risk assessment of readmissions following an initial COPD-related hospitalization. Int J Chron Obstruct Pulmon Dis. 2013;8:551-9. doi: 10.2147/COPD.S51507. Epub 2013 Nov 12.
Albert RK, Connett J, Bailey WC, Casaburi R, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Lazarus SC, Make B, Marchetti N, Martinez FJ, Madinger NE, McEvoy C, Niewoehner DE, Porsasz J, Price CS, Reilly J, Scanlon PD, Sciurba FC, Scharf SM, Washko GR, Woodruff PG, Anthonisen NR; COPD Clinical Research Network. Azithromycin for prevention of exacerbations of COPD. N Engl J Med. 2011 Aug 25;365(8):689-98. doi: 10.1056/NEJMoa1104623.
Zheng JP, Wen FQ, Bai CX, Wan HY, Kang J, Chen P, Yao WZ, Ma LJ, Li X, Raiteri L, Sardina M, Gao Y, Wang BS, Zhong NS; PANTHEON study group. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014 Mar;2(3):187-94. doi: 10.1016/S2213-2600(13)70286-8. Epub 2014 Jan 30.
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.
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Brightling CE, Bleecker ER, Panettieri RA Jr, Bafadhel M, She D, Ward CK, Xu X, Birrell C, van der Merwe R. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Respir Med. 2014 Nov;2(11):891-901. doi: 10.1016/S2213-2600(14)70187-0. Epub 2014 Sep 7.
Kawano T, Matsuse H, Obase Y, Kondo Y, Machida I, Tomari S, Mitsuta K, Fukushima C, Shimoda T, Kohno S. Hypogammaglobulinemia in steroid-dependent asthmatics correlates with the daily dose of oral prednisolone. Int Arch Allergy Immunol. 2002 Jul;128(3):240-3. doi: 10.1159/000064258.
Yip NH, Lederer DJ, Kawut SM, Wilt JS, D'Ovidio F, Wang Y, Dwyer E, Sonett JR, Arcasoy SM. Immunoglobulin G levels before and after lung transplantation. Am J Respir Crit Care Med. 2006 Apr 15;173(8):917-21. doi: 10.1164/rccm.200510-1609OC. Epub 2006 Jan 6.
Kazatchkine MD, Kaveri SV. Immunomodulation of autoimmune and inflammatory diseases with intravenous immune globulin. N Engl J Med. 2001 Sep 6;345(10):747-55. doi: 10.1056/NEJMra993360. No abstract available.
Ochsenbein AF, Fehr T, Lutz C, Suter M, Brombacher F, Hengartner H, Zinkernagel RM. Control of early viral and bacterial distribution and disease by natural antibodies. Science. 1999 Dec 10;286(5447):2156-9. doi: 10.1126/science.286.5447.2156.
Gelfand EW. Intravenous immune globulin in autoimmune and inflammatory diseases. N Engl J Med. 2012 Nov 22;367(21):2015-25. doi: 10.1056/NEJMra1009433. No abstract available.
Gilardin L, Bayry J, Kaveri SV. Intravenous immunoglobulin as clinical immune-modulating therapy. CMAJ. 2015 Mar 3;187(4):257-264. doi: 10.1503/cmaj.130375. Epub 2015 Feb 9. No abstract available.
Sabroe I, Postma D, Heijink I, Dockrell DH. The yin and the yang of immunosuppression with inhaled corticosteroids. Thorax. 2013 Dec;68(12):1085-7. doi: 10.1136/thoraxjnl-2013-203773. Epub 2013 Aug 8. No abstract available.
Fedor ME, Rubinstein A. Effects of long-term low-dose corticosteroid therapy on humoral immunity. Ann Allergy Asthma Immunol. 2006 Jul;97(1):113-6. doi: 10.1016/S1081-1206(10)61380-4.
Kaveri SV, Maddur MS, Hegde P, Lacroix-Desmazes S, Bayry J. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol. 2011 Jun;164 Suppl 2(Suppl 2):2-5. doi: 10.1111/j.1365-2249.2011.04387.x.
Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Clin Immunol. 2010 Oct;137(1):21-30. doi: 10.1016/j.clim.2010.06.012. Epub 2010 Aug 1.
Cowan J, Mulpuru S, Abdallah SJ, Chopra A, Purssell A, McGuinty M, Alvarez GG, Giulivi A, Corrales-Medina V, MacFadden D, Boyle L, Hasimja D, Thavorn K, Mallick R, Aaron SD, Cameron DW. A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD. Int J Chron Obstruct Pulmon Dis. 2021 Dec 3;16:3275-3284. doi: 10.2147/COPD.S338849. eCollection 2021.
Cowan J, Mulpuru S, Aaron S, Alvarez G, Giulivi A, Corrales-Medina V, Thiruganasambandamoorthy V, Thavorn K, Mallick R, Cameron DW. Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations. Pilot Feasibility Stud. 2018 Aug 11;4:135. doi: 10.1186/s40814-018-0327-z. eCollection 2018.
Related Links
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Microsoft Word - OLA Final Report June 21 - document.doc.
Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet - American Lung Association.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework - Health Quality Ontario (HQO).
GOLD\_Pocket\_2017\_Feb18.pdf
Intravenous immunoglobulin enhances the killing activity and autophagy of neutrophils isolated from immunocompromised patients against multidrug-re...
Other Identifiers
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20150925 / 20160077-01H
Identifier Type: -
Identifier Source: org_study_id
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