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

NCT03018652 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-11-26

No results posted yet for this study

Summary

Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory disease of the airways, associated with poor health status, functional disability, significant morbidity, and increased risk of death. In Ontario, COPD is the leading cause of hospital admission and readmission, and costs the health system approximately 3 billion dollars annually. Individuals with COPD experience increased 'flare-up's' (acute exacerbations) as their disease worsens, characterized by periods of increased shortness of breath, cough, phlegm production, and weakness. Acute exacerbations of COPD (AECOPD) are most commonly caused by viral or bacterial infections, and often require patients to seek attention at the emergency room or hospital for treatment. Current treatments to prevent COPD exacerbations are only modestly effective. New therapies are needed to improve the quality of life and clinical outcomes for individuals living with COPD.

Previous research at our center has shown a favourable effect of an antibody treatment (immunoglobulin) on the frequency of AECOPD, doctor visits, treatments, and hospitalizations for COPD patients. However, rigorous studies with more patients are required to confirm this effect.

The investigators propose a clinical trial to evaluate immunoglobulin treatment in outpatients with frequent exacerbations. In this study the investigators will determine if immunoglobulin treatment is feasible, safe, tolerable, and potentially effective in reducing the frequency of acute exacerbations. If this study is feasible and potentially effective, it will inform larger studies to confirm the therapeutic effect of immunoglobulin treatment, and would be a major advance in care of COPD.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Intravenous immunoglobulin

IVIG 0.5 g/kg, up to maximum of 80 grams will be given on the day of randomization and then every 4 ± 1 weeks for 44 weeks (Total 48 weeks)

DRUG

Normal Saline

5 mL/kg, up to maximum of 800 mL will be given on the day of randomization (this will match the volume of 0.5g/kg of IVIG product) and then every 4 ± 1 weeks for 44 weeks (Total 48 weeks)

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-11
Primary Completion
2019-11-20
Completion
2019-11-20

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018652 on ClinicalTrials.gov