A Safety, Tolerability and Efficacy Study in Chronic Obstructive Pulmonary Disease (COPD) Patients With QBM076.



Status:Terminated
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:35 - 75
Updated:4/21/2016
Start Date:November 2013
End Date:May 2015

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A Two Part, Double Blind, Placebo Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Doses of QBM076 in Patients With COPD

This was a 2 Part study. Part 1 was a safety and tolerability study in GOLD I-III COPD
patients. Part 2 was an efficacy study in GOLD I-III COPD patients.

Part 1 was a double-blind, randomized, placebo-controlled, non-confirmatory study in chronic
bronchitis COPD patients. Part 1 consisted of up to 27-days of screening period, one
baseline period of 1 day, 13 days of bid dosing with study treatment, morning only treatment
on Day 14, follow up visits on Days 15 - 17, followed by a Study Completion evaluation.
Twenty-seven patients were randomized in a 3:1 ratio to 3 cohorts..

Part 2 was a double-blind, randomized, placebo-controlled, non-confirmatory study in Gold
spirometry grades I-III COPD patients. Part 2 consisted of up to 20 days of screening
period, a 9 day run in period, one baseline period of 1 day, 55 days of bid dosing, morning
only dosing on Day 56, followed by Study Completion evaluation. It was planned to randomize
90 patients in a 2:1 ratio, but part 2 was terminated after 21 patients were enrolled. Three
of the 21 part 2 patients experienced moderate to severe (up to 17-fold) asymptomatic and
reversible elevation of liver transaminase levels after 3 weeks of treatment with QBM076 150
mg twice daily. Two of these patients had liver transaminase levels high enough to be
reported as serious adverse events suspected to be related to the study drug.

Inclusion Criteria:

- Part 1: Patients, smokers or ex-smokers with stable chronic bronchitis GOLD class
I-III chronic obstructive pulmonary disease (COPD); forced expiratory volume in 1
second ≥40% of predicted and forced expiratory volume in 1 second:forced vital
capacity ratio ≤0.7 post bronchodilator, respectively; diffusing capacity of the lung
for carbon monoxide ≥40%; a stable medical regimen for at least 4 weeks prior to
screening. Current smokers can be enrolled if they currently smoke ≤1ppd for last 3
months.

- Part 2: Patients, smokers or ex-smokers with GOLD spirometry class I-III COPD; a
stable medical regimen for at least 4 weeks prior to screening; high sensitivity
C reactive protein≥1.5 mg/L; forced expiratory volume in 1 second ≥30% of
predicted and forced expiratory volume in 1 second:forced vital capacity ratio
≤0.7 post bronchodilator, respectively; with mean lung clearance index 2.5% ≥8;
Ex-smokers with at least 10 pack year smoking history; or current smokers with
at least 10 pack year smoking history who smoke ≤ 1ppd on average for last 3
months.; evidence of air trapping based on radiologic criteria; women of child
bearing potential using effective methods of contraception

Exclusion Criteria:

- Part 1:Gold Class IV COPD, of moderate to significant emphysema, or evidence of
malignancy; medication considered potential for drug drug interaction; creatinine
clearance <30ml/min; more than 1 exacerbation requiring antibiotics or oral steroids
and/or hospitalization within 3 months of screening; women of child bearing potential
• Part 2: Gold spirometry grade IV COPD; medication considered a potential for drug
drug interaction; serum creatinine ≥1.9 mg/dL; more than 1 exacerbation requiring
antibiotics or oral steroids within 2 months and/or hospitalization within 3 months
of screening; any malignancy; evidence of severe emphysema as determined by HRCT; use
of oral steroids, theophylline, phosphodiesterase-4 inhibitors or oral antibiotic use
(eg.macrolides)
We found this trial at
2
sites
Richmond, Virginia 23249
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