Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD - Full Text View

Sponsored by:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00571428

Purpose

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

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

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

Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title:	Modified-Blind, Randomized, Multicenter, Single Dose, Two-Way Crossover Study of Arformoterol Tartrate Inhalation Solution 15μg BID vs. 30μg QD in Subjects With(COPD)

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

Primary: The primary endpoint will be the area under the FEV1 vs time curve over 24 hours [Time Frame: 24 hours(Changes in a measure of pulmonary function over a 24-hour period) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary: 1. Area under the FEV1 vs time curve over 12 hours (nAUC0-12-P). 2. Change in FEV1 at 24-hours (trough)3. Time to onset of response. (Measure: Other measures of pulmonary function, time to onset of response, duration of response ) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	33
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental A: Arformoterol 30 μg QD	Drug: Arformoterol Tartrate Inhalation Solution A.30/4ml QD B.15ug/2ml BID
B: Active Comparator B. Arformoterol 15 ųg BID	Drug: Arformoterol Tartrate Inhalation Solution A.30/4ml QD B.15ug/2ml BID

Detailed Description:

This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call.

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.
Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.

Exclusion Criteria:

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 Screening.
Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571428

Locations

United States, Oregon

Medford, Oregon, United States, 97504

Portland, Oregon, United States, 97213
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina

Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Director:

Pulmonary Medical Director

Sepracor, Inc.

More Information

Brovana Approved Labeling Text This link exits the ClinicalTrials.gov site

Responsible Party:	Sepracor Inc. ( Brovana Medical Director )
Study ID Numbers:	091-903
Study First Received:	December 10, 2007
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00571428
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

COPD
Chronic Bronchitis
Emphysema

Study placed in the following topic categories:

Emphysema
Pulmonary Emphysema
Naphazoline
Bronchitis, Chronic
Oxymetazoline
Lung Diseases, Obstructive
Respiratory Tract Diseases

Guaifenesin
Phenylephrine
Lung Diseases
Formoterol
Bronchitis
Phenylpropanolamine
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 13, 2009