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

NCT ID: NCT00424528

Last Updated: 2012-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Bronchitis Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arformoterol 15 mcg twice daily

Arformoterol 15 mcg twice daily/Placebo Inhalation Powder

Group Type ACTIVE_COMPARATOR

Arformoterol Tartrate Inhalation Solution

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo inhalation solution and placebo inhalation powder

Tiotropium 18 mcg once daily

Tiotropium 18 mcg once daily/Placebo Inhalation Solution

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo inhalation solution and placebo inhalation powder

Arformoterol /Tiotropium

Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily

Group Type EXPERIMENTAL

Arformoterol and Tiotropium

Intervention Type DRUG

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

Interventions

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Arformoterol Tartrate Inhalation Solution

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

Intervention Type DRUG

Tiotropium

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

Intervention Type DRUG

Arformoterol and Tiotropium

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

Intervention Type DRUG

Placebo

Placebo inhalation solution and placebo inhalation powder

Intervention Type DRUG

Other Intervention Names

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Brovana® Spiriva Brovana Spiriva

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Andrews, M.D.

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

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Jasper, Alabama, United States

Site Status

Tucson, Arizona, United States

Site Status

San Diego, California, United States

Site Status

Colorado Springs, Colorado, United States

Site Status

DeFuniak Springs, Florida, United States

Site Status

DeLand, Florida, United States

Site Status

Topeka, Kansas, United States

Site Status

Hazard, Kentucky, United States

Site Status

Madisonville, Kentucky, United States

Site Status

Marrero, Louisiana, United States

Site Status

Sunset, Louisiana, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Kalamazoo, Michigan, United States

Site Status

Saint Charles, Missouri, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Columbus, Ohio, United States

Site Status

Eugene, Oregon, United States

Site Status

Medford, Oregon, United States

Site Status

Portland, Oregon, United States

Site Status

East Providence, Rhode Island, United States

Site Status

Lincoln, Rhode Island, United States

Site Status

Columbia, South Carolina, United States

Site Status

Simpsonville, South Carolina, United States

Site Status

Spartanburg, South Carolina, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Tacoma, Washington, United States

Site Status

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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Tashkin DP, Donohue JF, Mahler DA, Huang H, Goodwin E, Schaefer K, Hanrahan JP, Andrews WT. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med. 2009 Apr;103(4):516-24. doi: 10.1016/j.rmed.2008.12.014. Epub 2009 Feb 8.

Reference Type DERIVED
PMID: 19208459 (View on PubMed)

Other Identifiers

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091-902

Identifier Type: -

Identifier Source: org_study_id

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