AZD2115 Dose 1
DrugAZD 2115, Dose 1 administered as two inhalations BID
NCT Number: NCT02109406
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).
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Notify Me40 year–80 year
All sexes
Interventional
Phase 2
Pearl Therapeutics Study Site, Clearwater, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 14 Days
Time frame: 14 Days
Time frame: 14 Days
Time frame: 14 Days
Time frame: Day 1
Time frame: 14 Days
Time frame: Day 1
Time frame: Day 1 through Day 15
Cmax, AUC0-12, AUC0-t, tmax, Apparent elimination half-life (t1/2), Apparent volume of distribution (Vd/F), Apparent total body clearance (CL/F)
Time frame: Day1 through Day 15
Safety will be assessed by adverse events (AEs), physical examination findings, dry mouth and tremor assessments, paradoxical bronchospasm, vital signs, electrocardiogram (ECG), and laboratory assessments.
Pearl Therapeutics, Inc.
Industry
A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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