Ig PRx in AECOPD: Pilot Study

Ottawa Hospital Research Institute48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hospitalized adult patient with AECOPD (clinically dominant AECOPD in the case of multiple co-morbidities eg. absence of overt lobar pneumonia or acute congestive heart failure or alternate diagnosis such as acute coronary syndrome or pulmonary embolism) * 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: * Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis) * 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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 104 weeks

Secondary Outcomes

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

Time frame: 104 weeks

Tolerability of treatment

The proportion of patients able to complete the treatment in the experimental arm during the study period versus in the control arm

Time frame: 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.

Time frame: 104 weeks

Efficacy trend: Health status

measured by the validated St. George Respiratory Questionnaire

Time frame: 104 weeks

Efficacy trend: Quality of life

validated quality of life measurement tool - EuroWol EQ-5D-5L

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 104 weeks

Ig PRx in AECOPD: Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes