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Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD

NCT02109406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-09-02

No results posted yet for this study

Summary

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).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

AZD2115 Dose 1

AZD 2115, Dose 1 administered as two inhalations BID

DRUG

AZD 2115, Dose 2

AZD 2115, Dose 2 administered as two inhalations BID

DRUG

Placebo MDI

Placebo MDI administered as two inhalations BID

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Shahid Siddiqui, MD · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109406 on ClinicalTrials.gov