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Completed

NCT Number: NCT02690038

Ig PRx in AECOPD: Pilot Study

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Gamunex, CBS IGIV-nex, Privigen, Octagam

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

Other names: Saline, Sodium Chloride

Primary outcomes

  1. Recruitment

    Time frame: 52 weeks

    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.

  2. Adherence and protocol compliance

    Time frame: 104 weeks

    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

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE

    Time frame: 104 weeks

    This will be assessed by documentation of adverse events in patients treated with Ig treatment versus control

  2. Tolerability of treatment

    Time frame: 104 weeks

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

  3. Efficacy trend: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) rates

    Time frame: 104 weeks

    AECOPD will be ascertained by monthly follow-up phone calls as well as questionnaires during study visits to detect inpatient/outpatient treatment for exacerbations.

  4. Efficacy trend: Health status

    Time frame: 104 weeks

    measured by the validated St. George Respiratory Questionnaire

  5. Efficacy trend: Quality of life

    Time frame: 104 weeks

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

  6. Efficacy trend: % predicted FEV1

    Time frame: 104 weeks

    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

  7. Efficacy trend: FEV1/FVC

    Time frame: 104 weeks

    FVC will be measured using a hand held spirometer, and will be recorded in Litres (L). Ratio of FEV1 and FVC will be reported.

  8. Efficacy trend: Health services use

    Time frame: 104 weeks

    Number of non-study physician visits, emergency department (ED) and hospital admissions over the twelve-month study period.

  9. Efficacy trend: Health care system cost

    Time frame: 104 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • CSL Behring
  • Grifols Biologicals, LLC

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2016
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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