This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
AZD 2115, Dose 1 administered as two inhalations BID
AZD 2115, Dose 2 administered as two inhalations BID
Placebo MDI administered as two inhalations BID
Pearl Therapeutics Study Site
Clearwater, Florida, United States
Pearl Therapeutics Study Site
Charleston, South Carolina, United States
Pearl Therapeutics Study Site
Spartanburg, South Carolina, United States
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
Time frame: 14 Days
Change from baseline in morning pre dose trough FEV1
Time frame: 14 Days
Peak change in FEV1
Time frame: 14 Days
Forced vital capacity (FVC) AUC0-12 relative to baseline
Time frame: 14 Days
Peak change in FEV1
Time frame: Day 1
Change from baseline in 12-hour post dose trough FEV1
Time frame: 14 Days
Time to onset of action
Time frame: Day 1
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