Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00665600

Purpose

To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Levalbuterol HCl Drug: Albuterol Sulfate Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period. [ Time Frame: Days -21, -14, 0, 14, 28, and 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Spirometry parameters [ Time Frame: Days -21, -14, 0, 14, 28, and 42 ] [ Designated as safety issue: No ]
Exacerbations of COPD [ Time Frame: Days -14, 0, 14, 28, 42 ] [ Designated as safety issue: Yes ]
COPD symptom ratings [ Time Frame: Days 0, 14, 28, 42 ] [ Designated as safety issue: Yes ]
Baseline dyspnea and transitional dyspnea indices [ Time Frame: Days 0, 14, 28, 42 ] [ Designated as safety issue: Yes ]
Ipatropium Bromide MDI use [ Time Frame: Day 0, 14, 28, 42 ] [ Designated as safety issue: Yes ]
Short acting Beta-agonist MDI use [ Time Frame: Days 0, 14, 28, 42 ] [ Designated as safety issue: Yes ]
Subject and physician global evaluations [ Time Frame: Days 14, 28, 42 ] [ Designated as safety issue: Yes ]
St. George's Hospital Respiratory Questionnaire (SGRQ). [ Time Frame: Days 0, 42 ] [ Designated as safety issue: Yes ]

Enrollment:	257
Study Start Date:	February 2002
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Levalbuterol 0.63 mg TID	Drug: Levalbuterol HCl Levalbuterol 0.63 TID Other Name: Xopenex HCl Inhalation Solution
Experimental: 2 Levalbuterol 1.25 mg TID	Drug: Levalbuterol HCl Levabuterol 1.25 mg TID Other Name: Xopenex HCl Inhalation Solution
Active Comparator: 3 Racemic Albuterol 2.5 mg TID	Drug: Albuterol Sulfate Racemic albuterol 2.5 mg TID Other Name: Ventolin Inhalation Solution
Placebo Comparator: 4 Placebo TID	Drug: Placebo Placebo TID

Detailed Description:

This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject. 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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects must be at least greater than or equal to 35 years of age at the time of consent.
Subjects must have a pre-established primary clinical diagnosis of COPD.
Subjects must have a baseline FEV1 less than or equal to 65%
Subjects must have a predicted and >0.70 Liter
subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
Subjects must have a greater than or equal to 15 pack-year smoking history
Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry

Exclusion Criteria:

Females who are pregnant or lactating.
Concurrent requirement of oxygen therapy
Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
Lung resection of more than one full lobe.
Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
History of upper or lower respiratory infection within 14 days of study entry.
Participation in an investigational drug study within 30 days of study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665600

Show 24 Study Locations

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Xopenex Medical Affairs Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00665600 History of Changes
Other Study ID Numbers:	051-914
Study First Received:	April 22, 2008
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

COPD
Chronic Bronchitis
Chronic Emphysema

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012