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

NCT00665600 | Completed Phase 3

• 1 other identifier: 051-914
• Study Type: interventional
• Target: 257
• Locations: 2 countries
• Sites: 24

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Chronic Bronchitis; Chronic Emphysema

Outcome Measures

Primary Outcomes (1)

• 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.

  Days -21, -14, 0, 14, 28, and 42

Secondary Outcomes (8)

• Spirometry parameters

  Days -21, -14, 0, 14, 28, and 42

• Exacerbations of COPD

  Days -14, 0, 14, 28, 42

• COPD symptom ratings

  Days 0, 14, 28, 42

• Baseline dyspnea and transitional dyspnea indices

  Days 0, 14, 28, 42

• Ipatropium Bromide MDI use

  Day 0, 14, 28, 42

Study Arms (4)

1

EXPERIMENTAL

Levalbuterol 0.63 mg TID

Drug: Levalbuterol HCl

2

EXPERIMENTAL

Levalbuterol 1.25 mg TID

Drug: Levalbuterol HCl

3

ACTIVE COMPARATOR

Racemic Albuterol 2.5 mg TID

Drug: Albuterol Sulfate

4

PLACEBO COMPARATOR

Placebo TID

Drug: Placebo

Interventions

Levalbuterol HCl DRUG

Levalbuterol 0.63 TID

Also known as: Xopenex HCl Inhalation Solution

1

Albuterol Sulfate DRUG

Racemic albuterol 2.5 mg TID

Also known as: Ventolin Inhalation Solution

3

Placebo DRUG

Placebo TID

4

Eligibility Criteria

• Age: 35 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (24)

Unknown Facility

Carmichael, California, United States

Location

Unknown Facility

Spring Valley, California, United States

Location

Unknown Facility

Wheat Ridge, Colorado, United States

Location

Unknown Facility

Largo, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Panama City, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Elk Grove Village, Illinois, United States

Location

Unknown Facility

Hines, Illinois, United States

Location

Unknown Facility

Wheaton, Maryland, United States

Location

Unknown Facility

Springfield, Massachusetts, United States

Location

Unknown Facility

Cadillac, Michigan, United States

Location

Unknown Facility

Columbia, Missouri, United States

Location

Unknown Facility

Missoula, Montana, United States

Location

Unknown Facility

Springfield, New Jersey, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Mogadore, Ohio, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Winnepeg, Manitoba, Canada

Location

Unknown Facility

Mississauga, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: February 1, 2002
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CA (4); US (20)