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| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
| Grifols Biologicals, LLC | INDUSTRY |
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This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive lung disease (COPD) patients with frequent exacerbations.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm 1: Treatment | Experimental | 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). |
|
| Intervention Arm 2: Control | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous immunoglobulin (IVIG) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Average number of patients being recruited per month. The study meets primary outcome if at least 4 patients can be recruited per month on average. | 52 weeks |
| Adherence and protocol compliance | Number and percentage of recruited patients adhere to the allocated treatment and protocol. We aim to achieve 80% adherence rate which is defined as at least 80% of patients adhere to 80% of allocated treatment and protocol | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE | This will be assessed by documentation of adverse events in patients treated with Ig treatment versus control | 104 weeks |
| Tolerability of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juthaporn Cowan, MD, PhD, FRCPC | Associate Scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26558756 | Background | Cowan J, Gaudet L, Mulpuru S, Corrales-Medina V, Hawken S, Cameron C, Aaron SD, Cameron DW. A Retrospective Longitudinal Within-Subject Risk Interval Analysis of Immunoglobulin Treatment for Recurrent Acute Exacerbation of Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Nov 11;10(11):e0142205. doi: 10.1371/journal.pone.0142205. eCollection 2015. | |
| 16144890 |
| Label | URL |
|---|---|
| Microsoft Word - OLA Final Report June 21 - document.doc. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 13, 2025 | |
| Reset | Sep 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 13, 2025 | Sep 4, 2025 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| C495669 | Octagam |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Normal Saline | Drug | 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 |
|
|
The proportion of patients able to complete the treatment in the experimental arm during the study period versus in the control arm
| 104 weeks |
| Efficacy trend: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) rates | AECOPD will be ascertained by monthly follow-up phone calls as well as questionnaires during study visits to detect inpatient/outpatient treatment for exacerbations. | 104 weeks |
| Efficacy trend: Health status | measured by the validated St. George Respiratory Questionnaire | 104 weeks |
| Efficacy trend: Quality of life | validated quality of life measurement tool - EuroWol EQ-5D-5L | 104 weeks |
| Efficacy trend: % predicted FEV1 | FEV1 value will be measured using a hand held spirometer. FEV1 value will be recorded in Litres (L) and reported as a percent of their predicted value (using the NHANES III reference standards for predicted values | 104 weeks |
| Efficacy trend: FEV1/FVC | FVC will be measured using a hand held spirometer, and will be recorded in Litres (L). Ratio of FEV1 and FVC will be reported. | 104 weeks |
| Efficacy trend: Health services use | Number of non-study physician visits, emergency department (ED) and hospital admissions over the twelve-month study period. | 104 weeks |
| Efficacy trend: Health care system cost | we will take the perspective of healthcare system and will measure the cost of health services use and an intervention. Intervention cost includes medication, staff, and equipment cost. | 104 weeks |
| Niewoehner DE, Rice K, Cote C, Paulson D, Cooper JA Jr, Korducki L, Cassino C, Kesten S. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med. 2005 Sep 6;143(5):317-26. doi: 10.7326/0003-4819-143-5-200509060-00007. |
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| 25667260 | Background | 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. |
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| 34887657 | Derived | 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. |
| 30116551 | Derived | 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. |
| Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet - American Lung Association. | View source |
| Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework - Health Quality Ontario (HQO). | View source |
| GOLD\_Pocket\_2017\_Feb18.pdf | View source |
| Intravenous immunoglobulin enhances the killing activity and autophagy of neutrophils isolated from immunocompromised patients against multidrug-re... | View source |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |