Efficacy Safety Study of Arformoterol/Tio Combo vs. Either Therapy Alone in COPD - Full Text View

Sponsored by:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00424528

Purpose

To evaluate and compare the efficacy of arformoterol BID and tiotropium QD (dosed sequentially) versus tiotropium QD alone in subjects with COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease Bronchitis Emphysema	Drug: Arformoterol Tartrate Inhalation Solution	Phase IV

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease) Emphysema

Drug Information available for: Tiotropium Tiotropium bromide Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	2-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy, Safety Study of Arformoterol Tartrate Inhalation Solution 2X Daily, Tiotropium 1X Daily, & Arformoterol Tartrate Inhalation Solution 2X Daily & Tiotropium 1X Daily in COPD Subjects

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

Primary: The primary endpoint will be the time-normalized area under the change from study baseline curve for FEV1 over 24 hours following two weeks of dosing. [ Time Frame: 24 hours following two weeks of dosing. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary: 1.Time-normalized area from study baseline curve for FEV1 over 0-12 hours after the first dose of study medication. 2. Time-normalized area under the change from study baseline curve for FEV1 over 0 12 hours) following 2 weeks of dosing. [ Time Frame: 0-12 hours following two weeks of dosing ] [ Designated as safety issue: Yes ]

Enrollment:	235
Study Start Date:	December 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arformoterol tartrate inhalation solution 15 ųg BID and placebo inhalation powder QD	Drug: Arformoterol Tartrate Inhalation Solution Arformoterol tartrate inhalation solution 15 ųg BID and placebo inhalation powder QD; Placebo inhalation solution BID and tiotropium inhalation powder 18 ųg QD; Arformoterol tartrate inhalation solution 15 ųg BID and Tiotropium inhalation powder 18 ųg QD
2: Experimental Placebo inhalation solution BID and tiotropium inhalation powder 18 ųg QD	Drug: Arformoterol Tartrate Inhalation Solution Arformoterol tartrate inhalation solution 15 ųg BID and placebo inhalation powder QD; Placebo inhalation solution BID and tiotropium inhalation powder 18 ųg QD; Arformoterol tartrate inhalation solution 15 ųg BID and Tiotropium inhalation powder 18 ųg QD
3: Active Comparator Arformoterol tartrate inhalation solution 15 ųg BID and Tiotropium inhalation powder 18 ųg QD	Drug: Arformoterol Tartrate Inhalation Solution Arformoterol tartrate inhalation solution 15 ųg BID and placebo inhalation powder QD; Placebo inhalation solution BID and tiotropium inhalation powder 18 ųg QD; Arformoterol tartrate inhalation solution 15 ųg BID and Tiotropium inhalation powder 18 ųg QD

Detailed Description:

This study is a placebo controlled, multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution BID, tiotropium inhalation powder QD and arformoterol tartrate inhalation solution BID and tiotropium inhalation powder QD (dosed sequentially) in subjects with COPD.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424528

Show 28 Study Locations

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Chair:

John Hanrahan, M.D.

Sepracor, Inc.

More Information

Brovana® Patient Medication Guide This link exits the ClinicalTrials.gov site

Responsible Party:	Sepracor Inc. ( John Hanrahan )
Study ID Numbers:	091-902
Study First Received:	January 17, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00424528
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

COPD including chronic bronchitis and emphysema

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Formoterol
Bronchitis
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Bronchial Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009