Clinical trial NCT02130635
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: PI3Kd Pharmacodynamics dry powder inhaler GSK2269557 safety COPD subjects
Sponsor: GlaxoSmithKline
Start date: 2014-07-31; Completion date: 2015-08-18
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557 administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will also be assessed. This study will have two parts. In Part A, subjects will be randomized to active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses of active treatment in an equal ratio. A sufficient number of COPD subjects (male and female of non-child bearing potential) will be screened to ensure that approximately 30 subjects are enrolled and at least 20 evaluable subjects are obtained for Part A and approximately 35 subjects will be enrolled for Part B. In both the parts, subjects will receive study treatment once daily for 14 consecutive days. Placebo control will be included for a valid evaluation of adverse events attributable to treatment versus those independent of treatment.

Detailed description:

Arms: arm 1: Subjects will receive 2 inhalations (2 x GSK2269557 500 mcg = total dose of 1000 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days arm 2: Subjects will receive 2 inhalations of placebo once daily for 14 consecutive days arm 3: Subjects will receive 4 inhalations (1 x GSK2269557 100 mcg and 3 x Placebo = total dose of 100 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days arm 4: Subjects will receive 4 inhalations (2 x GSK2269557 100 mcg and 2 x Placebo = total dose of 200 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days arm 5: Subjects will receive 4 inhalations (1 x GSK2269557 500 mcg and 3 x Placebo = total dose of 500 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days, once daily for 14 consecutive days arm 6: Subjects will receive 4 inhalations (1 x GSK2269557 500 mcg, 2 x GSK2269557 100 mcg and 1 x Placebo = total dose of 700 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days arm 7: Subjects will receive 4 inhalations (2 x GSK2269557 100 mcg and 2 x Placebo = total dose of 1000 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days arm 8: Subjects will receive 4 inhalations (2 x GSK2269557 100 mcg and 2 x Placebo = total dose of 2000 mcg GSK2269557) 30 seconds apart, once daily for 14 consecutive days arm 9: Subjects will receive 4 inhalations of placebo once daily for 14 consecutive days
Interventions: intervention 1: GSK2269557 100 MCG intervention 2: GSK2269557 500 MCG intervention 3: PLACEBO
Intervention descriptions: intervention 1: 100 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device intervention 2: 500 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device intervention 3: Lactose administered using a matching dry powder inhaler device

Protocol documents: