Clinical trial NCT02690038: Ig PRx in AECOPD: Pilot Study
Official title: Feasibility and Safety of Immunoglobulin (Ig) Prophylactic Treatment in COPD Patients With Frequent Exacerbations: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: AECOPD
COPD
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: CSL Behring
name: Grifols Biologicals, LLC
First posted: 2016-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: 52 weeks
measure: Adherence and protocol compliance
timeFrame: 104 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE
timeFrame: 104 weeks
measure: Tolerability of treatment
timeFrame: 104 weeks
measure: Efficacy trend: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) rates
timeFrame: 104 weeks
measure: Efficacy trend: Health status
timeFrame: 104 weeks
measure: Efficacy trend: Quality of life
timeFrame: 104 weeks
measure: Efficacy trend: % predicted FEV1
timeFrame: 104 weeks
measure: Efficacy trend: FEV1/FVC
timeFrame: 104 weeks
measure: Efficacy trend: Health services use
timeFrame: 104 weeks
measure: Efficacy trend: Health care system cost
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: Associate Scientist
name: Juthaporn Cowan, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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