The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H 8L6, Canada
NCT Number: NCT02690038
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.
Looking for future studies?
Notify Me40 year and older
All sexes
Interventional
Phase 2
Ottawa, Ontario, K1H 8L6, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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
Time frame: 104 weeks
This will be assessed by documentation of adverse events in patients treated with Ig treatment versus control
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
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.
Time frame: 104 weeks
measured by the validated St. George Respiratory Questionnaire
Time frame: 104 weeks
validated quality of life measurement tool - EuroWol EQ-5D-5L
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
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.
Time frame: 104 weeks
Number of non-study physician visits, emergency department (ED) and hospital admissions over the twelve-month study period.
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.
Ottawa Hospital Research Institute
Other
Feasibility and Safety of Immunoglobulin (Ig) Prophylactic Treatment in COPD Patients With Frequent Exacerbations: A Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT05984823
Chronic Disease, Chronic Obstructive Pulmonary Disease
Leicester, Leicestershire, United Kingdom
View Trial DetailsNCT05572333
COPD, Chronic Disease
Frankfurt, Germany
View Trial DetailsNCT03641235
Chronic Disease, Chronic Obstructive Pulmonary Disease
Bordeaux, France
View Trial DetailsNCT05984680
Chronic Disease, Chronic Obstructive Pulmonary Disease
Winston-Salem, North Carolina, United States
View Trial Details