Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

NCT00073827 | Completed Phase 3

• 1 other identifier: 051-353
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 63

Brief Summary

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Conditions

Asthma

Keywords

adolescent; adult; asthma; levalbuterol; bronchoconstriction

Outcome Measures

Primary Outcomes (1)

• percent change in FEV1 from visit predose averaged over the 8-week double-blind period

  Weeks 0, 4, 8

Secondary Outcomes (7)

• area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period

  Weeks 0, 4, 8

• peak percent change in FEV1 from study baseline

  Weeks 0, 4, 8

• peak change in FEV1 from visit predose

  Weeks 0, 4, 8

• peak percent of predicted FEV1

  Weeks 0, 4, 8

• area under the FEV1 curve (AUC)

  Weeks 0, 4, 8

Study Arms (3)

1

EXPERIMENTAL

levalbuterol MDI 90 mcg QID

Drug: levalbuterol tartrate MDI

2

ACTIVE COMPARATOR

racemic albuterol MDI 180 mcg QID

Drug: racemic albuterol MDI

3

PLACEBO COMPARATOR

Placebo MDI QID

Drug: Placebo

Interventions

levalbuterol tartrate MDI DRUG

levalbuterol 90 mcg QID

Also known as: Xopenex MDI

1

racemic albuterol MDI DRUG

racemic albuterol 180 mcg QID

2

Placebo DRUG

Placebo MDI QID

3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to comply with the study procedures and visit schedules
• Male or female, at least 12 years of age
• Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.
• Women of child bearing potential must be using an acceptable method of birth control
• Have a documented diagnosis of asthma for a minimum of 6 months prior to study start
• Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 months prior to study start
• Must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
• Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
• Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, and demonstrate how to use the MiniWright PEF meter.

You may not qualify if:

• Female subject who is pregnant or lactating
• Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
• Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
• Subject who has travel commitments during the study that would interfere with trial measurements or compliance
• Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery
• Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations
• Subject using any prescription drug with which albuterol sulfate administration is contraindicated
• Subject with currently diagnosed life-threatening asthma
• History of cancer (exception: basal cell carcinoma in remission).
• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication
• History of substance abuse or drug abuse within 12 months preceding study start
• Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start
• Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
• Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start
• Subject who is a staff member or relative of a staff member

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (63)

Alabama Asthma and Allergy Center

Homewood, Alabama, 35209, United States

Location

MDC Research

Mobile, Alabama, 36607, United States

Location

Integrated Research Group

Corona, California, 92879, United States

Location

Allergy & Asthma Medical Group of Diablo Valley, Inc.

Danville, California, 94526, United States

Location

Radiant Research, Inc.

Encinitas, California, 92024, United States

Location

Allergy & Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Allergy, Asthma & Respiratory Care Center

Long Beach, California, 90806, United States

Location

Allergy Research Foundation, Inc.

Los Angeles, California, 90025, United States

Location

Clinical Trials of Orange County

Orange, California, 92868, United States

Location

Allergy Associates Medical Group

San Diego, California, 92120, United States

Location

Allergy & Asthma Medical Group & Research Center

San Diego, California, 92123, United States

Location

Allergy & Asthma Prevention & Treatment Center

San Diego, California, 92131, United States

Location

Allergy & Asthma Assoc. of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Southern California Research Center

Viejo, California, 92691, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

Clinical Research Centers of Colorado PC

Englewood, Colorado, 80112, United States

Location

Asthma & Allergy Associates, PC

Pueblo, Colorado, 81001, United States

Location

Office of Ronald Saff

Tallahassee, Florida, 32308, United States

Location

Aeroallergy Research Laboratories of Savannah, Inc.

Savannah, Georgia, 31406, United States

Location

Radiant Research Honolulu

Honolulu, Hawaii, 96814, United States

Location

Clinical Research Center of Indiana

Indianapolis, Indiana, 46208, United States

Location

Allergy & Asthma Care Specialists

Metairie, Louisiana, 70006, United States

Location

Northshore Medical Research

Slidell, Louisiana, 70458, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, United States

Location

PCHI

Needham, Massachusetts, 02494, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Center for Clinical Research

Taunton, Massachusetts, 02780, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Mississippi Asthma & Allergy Clinic

Jackson, Mississippi, United States

Location

Office of Clinical Research, University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Division of Allergy & Immunology, Washington Univ School of Med

St Louis, Missouri, 63110, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Princeton Center for Clinical Research

Princeton, New Jersey, 08540, United States

Location

Pulmonary and Allergy Associates

Springfield, New Jersey, 07081, United States

Location

PCCS

Albany, New York, 12205, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Regional Allergy & Asthma Consultants

Asheville, North Carolina, 28801, United States

Location

Cornerstone Research Care

High Point, North Carolina, 27262, United States

Location

Raleigh Pediatric Associates

Raleigh, North Carolina, 27609, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231, United States

Location

Allergy & Asthma Research

Eugene, Oregon, 97401, United States

Location

Allergy Associates Research Center, LLC

Portland, Oregon, 97213, United States

Location

Asthma & Allergy Research Associates

Chester, Pennsylvania, 19013, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Division of Pulmonary

Pittsburgh, Pennsylvania, 15213, United States

Location

Radiant Research

Charleston, South Carolina, 29407, United States

Location

Office of Neil Kao

Greenville, South Carolina, 29607, United States

Location

Allergy & Asthma Consultants, LLP

Mt. Pleasant, South Carolina, 29464, United States

Location

Office of Constantine Saadeh

Amarillo, Texas, 79106, United States

Location

Allergy & Asthma Research Associates

Dallas, Texas, 75231, United States

Location

North Texas Institute for Clinical Trials

Fort Worth, Texas, 76132, United States

Location

Breath of Life Research Institute

Houston, Texas, 77054, United States

Location

Lung Diagnostics

San Antonio, Texas, United States

Location

Allergy & Asthma Center

Waco, Texas, United States

Location

Children's Hospital of the Kings Daughters

Norfolk, Virginia, 23507, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23225, United States

Location

ASTHMA, Inc.

Seattle, Washington, 98105, United States

Location

Allergic Diseases, SC

West Allis, Wisconsin, 53227, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: December 9, 2003
• First Posted: December 11, 2003
• Study Start: May 1, 2002
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (63)