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

Sumitomo Pharma

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema; Bronchitis

Treatments: Drug: Arformoterol and Tiotropium; Drug: Tiotropium; Drug: Placebo; Drug: Arformoterol Tartrate Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424528

091-902

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 235 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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235 participants in 3 patient groups

Arformoterol 15 mcg twice daily

Active Comparator group

Description:

Arformoterol 15 mcg twice daily/Placebo Inhalation Powder

Treatment:

Drug: Arformoterol Tartrate Inhalation Solution

Drug: Placebo

Tiotropium 18 mcg once daily

Active Comparator group

Description:

Tiotropium 18 mcg once daily/Placebo Inhalation Solution

Treatment:

Drug: Placebo

Drug: Tiotropium

Arformoterol /Tiotropium

Experimental group

Description:

Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily

Treatment:

Drug: Arformoterol and Tiotropium