Evidence map›Paper›PMID 34887657›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD.

Juthaporn Cowan, Sunita Mulpuru, Sara J Abdallah, Anchal Chopra, Andrew Purssell, Michaeline McGuinty, Gonzalo G Alvarez, Antonio Giulivi, Vicente Corrales-Medina, Derek MacFadden and 6 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02690038 phase2completednot on this map

Feasibility and Safety of Immunoglobulin (Ig) Prophylactic Treatment in COPD Patients With Frequent Exacerbations: A Pilot Study

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2016 to 2019Enrolled48ConditionsChronic Obstructive Pulmonary DiseaseArmsIntravenous immunoglobulin (IVIG), Normal Saline
NCT03018652 phase2completednot on this map

Feasibility and Safety of Immunoglobulin (Ig) Treatment in COPD Outpatients With Frequent Exacerbations: Pilot Study 1

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2018 to 2019Enrolled22ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsIntravenous immunoglobulin, Normal Saline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Effectiveness of immunoglobulin replacement therapy in preventing infections in patients with chronic obstructive pulmonary disease: a systematic review.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024
    Article
  3. The Impact of Chronic Bronchial Infection in COPD: A Proposal for Management.International journal of chronic obstructive pulmonary disease · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Juthaporn CowanDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.ORCID 0000-0001-6648-5109
Sunita MulpuruDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.ORCID 0000-0001-6214-0613
Sara J AbdallahClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Anchal ChopraInterdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada.ORCID 0000-0003-1250-7485
Andrew PurssellDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Michaeline McGuintyDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Gonzalo G AlvarezDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Antonio GiuliviClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Vicente Corrales-MedinaDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Derek MacFaddenDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Loree BoyleDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Delvina HasimjaDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Kednapa ThavornClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Ranjeeta MallickClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Shawn D AaronDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
D William CameronDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObservational studies suggest that immunoglobulin treatment may reduce the frequency of acute exacerbations of COPD (AECOPD).

objectiveTo inform the design of a future randomised control trial (RCT) of intravenous immunoglobulin (IVIG) treatment efficacy for AECOPD prevention.

methodsA pilot RCT was conducted. We recruited patients with COPD hospitalized for AECOPD, or from ambulatory clinics with one severe, or two moderate AECOPD in the previous year regardless of their serum IgG level. Patients were allocated in a 1:1 ratio with balanced randomisation to monthly IVIG or normal saline for 1 year. The primary outcome was feasibility defined as pre-specified accrual, adherence, and follow-up rates. Secondary outcomes included safety, tolerance, AECOPD rates, time to first AECOPD, quality of life, and healthcare costs.

resultsSeventy patients were randomized (37 female; mean age 67.7; mean FEV1 35.1%). Recruitment averaged 4.5±0.9 patients per month (range 0-8), 34 (49%) adhered to at least 80% of planned treatments, and four (5.7%) were lost to follow-up. There were 35 serious adverse events including seven deaths and one thromboembolism. None was related to IVIG. There were 56 and 48 moderate and severe AECOPD in the IVIG vs control groups. In patients with at least 80% treatment adherence, median time to first moderate or severe AECOPD was 275 vs 114 days, favoring the IVIG group (HR 0.76, 95% CI 0.3-1.92).

conclusionThe study met feasibility criteria for recruitment and retention, but adherence was low. A trend toward more robust treatment efficacy in adherent patients supports further study, but future trials must address treatment adherence. TRIAL REGISTRATION NUMBER: NCT0290038, registered 24 February 2016, https://clinicaltrials.gov/ct2/show/NCT02690038 and NCT03018652, registered January 12, 2017, https://clinicaltrials.gov/ct2/show/NCT03018652.

Indexed as

Pulmonary Disease, Chronic ObstructiveAgedDouble-Blind MethodFeasibility StudiesFemaleHumansImmunoglobulinsTreatment OutcomeImmunoglobulinsimmunoglobulin treatmentIVIGpilot RCTrecurrent AECOPD

Identifiers

PMID34887657
PMCPMC8650772

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.