Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00665600

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2003-03-31

Brief Summary

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

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Levalbuterol 0.63 mg TID

Group Type: EXPERIMENTAL

Levalbuterol HCl

Intervention Type: DRUG

Levalbuterol 0.63 TID

2

Levalbuterol 1.25 mg TID

Group Type: EXPERIMENTAL

Levalbuterol HCl

Intervention Type: DRUG

Levabuterol 1.25 mg TID

3

Racemic Albuterol 2.5 mg TID

Group Type: ACTIVE_COMPARATOR

Albuterol Sulfate

Intervention Type: DRUG

Racemic albuterol 2.5 mg TID

4

Placebo TID

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo TID

Interventions

Levalbuterol HCl

Levalbuterol 0.63 TID

Intervention Type: DRUG

Levalbuterol HCl

Levabuterol 1.25 mg TID

Intervention Type: DRUG

Albuterol Sulfate

Racemic albuterol 2.5 mg TID

Intervention Type: DRUG

Placebo

Placebo TID

Intervention Type: DRUG

Other Intervention Names

Xopenex HCl Inhalation Solution; Xopenex HCl Inhalation Solution; Ventolin Inhalation Solution

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Carmichael, California, United States

Spring Valley, California, United States

Wheat Ridge, Colorado, United States

Largo, Florida, United States

Miami, Florida, United States

Panama City, Florida, United States

Atlanta, Georgia, United States

Elk Grove Village, Illinois, United States

Hines, Illinois, United States

Wheaton, Maryland, United States

Springfield, Massachusetts, United States

Cadillac, Michigan, United States

Columbia, Missouri, United States

Missoula, Montana, United States

Springfield, New Jersey, United States

Chapel Hill, North Carolina, United States

Mogadore, Ohio, United States

Providence, Rhode Island, United States

Austin, Texas, United States

San Antonio, Texas, United States

Calgary, Alberta, Canada

Winnepeg, Manitoba, Canada

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

051-914

Identifier Type: -

Identifier Source: org_study_id