Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

Sumitomo Pharma America, Inc.235 enrolled

Overview

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

235

Conditions

Chronic Obstructive Pulmonary Disease Bronchitis Emphysema

Interventions

Arformoterol Tartrate Inhalation SolutionDRUG

Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.

TiotropiumDRUG

Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.

Arformoterol and TiotropiumDRUG

Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects must be at least 45 years old at the time of consent. * Subjects must have a pre-established primary clinical diagnosis of COPD. * Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1. * Subjects must have a FEV1 ≥ 0.70L at Visit 1. Exclusion Criteria: * Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1. * Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 1.

Locations (28)

Unnamed facility

Jasper, Alabama, United States

Outcomes

Primary Outcomes

Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)

Time frame: 24 hours following two weeks of dosing.

Secondary Outcomes

Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)

Time frame: 0-12 hours following two weeks of dosing

Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)

Time frame: Following 2 weeks of dosing

Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)

Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.

Time frame: Following 2 weeks of dosing

Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication

Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.

Time frame: 2 weeks

Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication

Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.

Time frame: 2 weeks

Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline

12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.

Data from ClinicalTrials.gov

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