Conditions: COPD
Keywords: COPD, inflammation, small airways, LCI, PFTs, lung heterogeneity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants received QBM076 25 mg twice daily (bid) for 14 days. arm 2: Participants received QBM076 75 mg bid for 14 days. arm 3: Participants received QBM076 150 mg bid for 14 days. arm 4: Participants in each cohort received matching placebo for 14 days. arm 5: Participants received QBM076 150 mg bid for 8 weeks. arm 6: Participants received matching placebo for 8 weeks.

Interventions: intervention 1: QBM076 intervention 2: Placebo
Intervention descriptions: intervention 1: Supplied in 25 mg and 75 mg capsules intervention 2: Matching placebo capsules

Protocol document: