A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).
Total of 20 adult patients will be chosen from population of adults between the age of 40 to 80 diagnosed with COPD to be randomized to 1 of 2 treatment arms including IV infusion of Zofin or IV infusion on sterile saline. The subjects will be followed for 12 months to demonstrate safety and efficacy of Zofin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Mayo Clinic
Phoenix, Arizona, United States
Safety of Zofin
To demonstrate the safety of Zofin administered intravenously in subjects with COPD by measuring incidence of any of the following treatment-emergent serious adverse events (TE-SAEs) within the first 30 days of infusion: * Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). * Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea). * Event resulting in persistent or significant disability/incapacity. * Event resulting in death. Frequency and severity of any adverse events from Day 0 (day of treatment) up to 12 months of treatment will similarly be observed.
Time frame: first 30 days
Safety of Zofin
To monitor the frequency and severity of adverse events
Time frame: day 0 to 12 months
FVC
FVC from resting PFT
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEV1
FEV1 from resting PFT
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEV1 to FVC ratio
FEV1 to FVC ratio on resting pulmonary function test
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
FEF25-75
FEF25-75 on resting pulmonary function test
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
Lung Volume Changes
Change in lung volumes (in body plethysmograph), including SGAW (specific airway conductance) and RV (to calculate gas trapping)
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Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
DLCO
Change in single breath diffusing capacity of lung for carbon monoxide (DLCO)
Time frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
HU of CT Scan
Change in the average of Hounsfield Unit (HU) - a relative quantitative measurement of radio density in CT images.
Time frame: Screen and 12 months
% air in lung on CT Scan
Change in the percentage of air in the lung
Time frame: Screen and 12 months
CPET
Cardiopulmonary Exercise Testing (CPET) with peak VO2 and measures of dynamic hyperinflation
Time frame: Screen, 4 months, and 12 months
Peak VO2
Cardiopulmonary Exercise Testing (CPET) with peak VO2
Time frame: Screen, 4 months, and 12 months
Dynamic Hyperinflation
Cardiopulmonary Exercise Testing (CPET) with measures of dynamic hyperinflation
Time frame: Screen, 4 months, and 12 months
Pulmonary Exacerbation
Incidence of investigator-defined pulmonary exacerbation: decrease in exacerbation-related hospitalization
Time frame: Screening through 12 months
TNF-α
Change in serum inflammatory markers: TNF-α
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
CRP
Change in serum inflammatory markers: CRP
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
IL-1
Change in serum inflammatory markers: IL-1
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
D-Dimer
Change in serum inflammatory markers: D-dimer
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
Fibrinogen
Change in serum inflammatory markers: Fibrinogen
Time frame: Day 0, Day14, 4 months, 8 months, and 12 months
SF-36 ot SGRQ
Change in SF-36 questionnaire or St. George's Respiratory Questionnaire (SGRQ)
Time frame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
CAT Assessment
Change in quality of life (QOL) assessments via COPD Assessment Test (CAT)
Time frame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months