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

June 26, 2023 updated by: Sunovion

A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Manitoba
      • Winnepeg, Manitoba, Canada
    • Ontario
      • Mississauga, Ontario, Canada
      • Toronto, Ontario, Canada
  • United States
    • California
      • Carmichael, California, United States
      • Spring Valley, California, United States
    • Colorado
      • Wheat Ridge, Colorado, United States
    • Florida
      • Largo, Florida, United States
      • Miami, Florida, United States
      • Panama City, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Elk Grove Village, Illinois, United States
      • Hines, Illinois, United States
    • Maryland
      • Wheaton, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Cadillac, Michigan, United States
    • Missouri
      • Columbia, Missouri, United States
    • Montana
      • Missoula, Montana, United States
    • New Jersey
      • Springfield, New Jersey, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Mogadore, Ohio, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Texas
      • Austin, Texas, United States
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Levalbuterol 0.63 mg TID
Drug: Levalbuterol HCl
Levalbuterol 0.63 TID
Other Names:
  • Xopenex HCl Inhalation Solution
Drug: Levalbuterol HCl
Levabuterol 1.25 mg TID
Other Names:
  • Xopenex HCl Inhalation Solution
Experimental: 2
Levalbuterol 1.25 mg TID
Drug: Levalbuterol HCl
Levalbuterol 0.63 TID
Other Names:
  • Xopenex HCl Inhalation Solution
Drug: Levalbuterol HCl
Levabuterol 1.25 mg TID
Other Names:
  • Xopenex HCl Inhalation Solution
Active Comparator: 3
Racemic Albuterol 2.5 mg TID
Drug: Albuterol Sulfate
Racemic albuterol 2.5 mg TID
Other Names:
  • Ventolin Inhalation Solution
Placebo Comparator: 4
Placebo TID
Drug: Placebo
Placebo TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days -21, -14, 0, 14, 28, and 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Spirometry parameters
Time Frame: Days -21, -14, 0, 14, 28, and 42
Days -21, -14, 0, 14, 28, and 42
Exacerbations of COPD
Time Frame: Days -14, 0, 14, 28, 42
Days -14, 0, 14, 28, 42
COPD symptom ratings
Time Frame: Days 0, 14, 28, 42
Days 0, 14, 28, 42
Baseline dyspnea and transitional dyspnea indices
Time Frame: Days 0, 14, 28, 42
Days 0, 14, 28, 42
Ipatropium Bromide MDI use
Time Frame: Day 0, 14, 28, 42
Day 0, 14, 28, 42
Short acting Beta-agonist MDI use
Time Frame: Days 0, 14, 28, 42
Days 0, 14, 28, 42
Subject and physician global evaluations
Time Frame: Days 14, 28, 42
Days 14, 28, 42
St. George's Hospital Respiratory Questionnaire (SGRQ).
Time Frame: Days 0, 42
Days 0, 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimated)

April 24, 2008

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051-914

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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