Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

NCT00064389 | Completed Phase 3

• 1 other identifier: 051-356
• Study Type: interventional
• Target: 746
• Locations: 2 countries
• Sites: 96

Brief Summary

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• incidence of post-randomization adverse events

  Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

Secondary Outcomes (13)

• rate of discontinuations due to adverse events

  Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

• time-to-selected adverse events (AEs with an incidence ≥5%)

  Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

• asthma attacks, asthma adverse events, and expanded-definition asthma events

  Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

• clinical laboratory values

  Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53

• vital signs (blood pressure, heart rate, respiration rate, and body temperature)

  Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53

Study Arms (2)

1

EXPERIMENTAL

levalbuterol 90 mcg MDI QID

Drug: levalbuterol tartrate HFA MDI

2

ACTIVE COMPARATOR

racemic albuterol HFA MDI 180 mcg QID

Drug: racemic albuterol

Interventions

levalbuterol tartrate HFA MDI DRUG

levalbuterol MDI 90 mcg QID

Also known as: Xopenex HFA MDI

1

racemic albuterol DRUG

racemic albuterol HFA MDI 180 mcg QID

2

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 study procedures and visit schedules
• Females 12-60 yrs must have a negative serum pregnancy test at study start
• Women of child bearing potential must use acceptable method of birth control throughout study
• Confirmed diagnosis of asthma minimum of 6 mos. prior to study start
• Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. \>6 mos. prior to study start
• In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
• Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc.
• Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study
• Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait \>30 days and will be regarded as a de novo subject
• Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities

You may not qualify if:

• Female who is pregnant or lactating
• Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355
• Subject who early terminated from Sepracor study 051-353 or 051-355
• Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM
• Have travel commitments during the study that would interfere with trial measurements and/or compliance
• History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during the trial
• Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations
• Subject using any prescription drug with which albuterol sulfate 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 or may interfere with the successful completion of this protocol
• History of substance abuse or drug abuse within 12 months preceding V1
• Subject with \>10 pack/yr 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (96)

Jefferson Clinic PC

Birmington, Alabama, 35233, United States

Location

Pulmonary Associates Research Division

Mobile, Alabama, 36608, United States

Location

Montgomery Pulmonary Consultants

Montgomery, Alabama, 36111, United States

Location

Center of Research Excellence, LLC

Oxford, Alabama, 36203, United States

Location

Lovelace Scientific Resources

Phoenix, Arizona, 85016, United States

Location

Alta Clinical Research, LLC

Tucson, Arizona, 85745, United States

Location

Integrated Research Group

Corona, California, 92506, United States

Location

Northern California Research Corp

Fair Oaks, California, 95628, United States

Location

Allergy, Asthma & Respiratory Care Center

Long Beach, California, 90806, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Clinical Trials of Orange County, Inc.

Orange, California, 92868, United States

Location

Institute of Healthcare Assessment, Inc.

San Diego, California, 92120, United States

Location

Westlake Medical Research, Inc.

Westlake Village, California, 91361, United States

Location

Office of Constantine Falliers, MD

Denver, Colorado, 80209, United States

Location

Office of Gary Richmond, MD

Fort Lauderdale, Florida, 33316, United States

Location

CNS Clinical Trials

Fort Myers, Florida, 33907, United States

Location

FPA Clinical Research

Kissimmee, Florida, 34741, United States

Location

Orlando Clinic for Asthma & Respiratory Diseases

Longwood, Florida, 32750, United States

Location

Allergy Sinus Asthma Research Institute

Miami, Florida, 33173, United States

Location

Florida Center for Alergy & Asthma Research

Miami, Florida, 33176, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

Family Allergy & Asthma Center, PC

Atlanta, Georgia, 30342, United States

Location

The Allergy & Asthma Clinic Research Center

Conyers, Georgia, 30013, United States

Location

Aeroallergy Research

Savannah, Georgia, 31046, United States

Location

Sneeze, Wheeze and Itch, LLC

Bloomington, Illinois, 61761, United States

Location

Rush Presbyterian - St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Asthma Respiratory & Exercise Specialists

Glenview, Illinois, 60025, United States

Location

Cardinal Respiratory, PC

Springfield, Illinois, United States

Location

Clinical Research Center of Indiana

Indianapolis, Indiana, 46208, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Consultants in Pulmonary Medicine

Olathe, Kansas, 66061, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Northshore Medical Research

Covington, Louisiana, 70433, United States

Location

Institute for Asthma & Allergy, PC

Wheaton, Maryland, United States

Location

Center for Clinical Research

Taunton, Massachusetts, 02780, United States

Location

Henry Ford Hospital & Medical Centers

Detroit, Michigan, 48202, United States

Location

Hurley Child and Adolescent Asthma Center

Flint, Michigan, 45832, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Allergy, Asthma, Immunology Services, LLC

Jefferson City, Missouri, 65101, United States

Location

Midwest Chest Consultants, PC

Saint Charles, Missouri, 63301, United States

Location

Washington University School of Medicine, Division of Allergy & Immunology

St Louis, Missouri, 63110, United States

Location

Montana Medical Research, LLC

Missoula, Montana, 59804, United States

Location

Allergy, Asthma & Immunology Associates, PC

Lincoln, Nebraska, 68505, United States

Location

Heartland Clinical Research Inc.

Omaha, Nebraska, 68134, United States

Location

Office of Meera Dewan, MD

Omaha, Nebraska, 68144, United States

Location

Delaware Valley Institute for Clinical Research

Cherry Hill, New Jersey, 08003, United States

Location

Clinical Research Center of Allergy & Asthma Consultants

Tinton Falls, New Jersey, 07701, United States

Location

Lovelace Scientific Resources

Albuquerque, New Mexico, 87108, United States

Location

Allergy & Asthma of Northern NM

Los Alamos, New Mexico, 87544, United States

Location

Pulmonary Medical Research of NY

Bay Shore, New York, 11706, United States

Location

Asthma & Allergy Associates, PC

Cortland, New York, 13045, United States

Location

Office of Michael Marcus, MD

Staten Island, New York, 10304, United States

Location

Office of Richard Castaldo

Tonawanda, New York, 14150, United States

Location

Regional Allergy & Asthma Consultants

Asheville, North Carolina, 28801, United States

Location

Charlotte Lung & Health Center

Charlotte, North Carolina, 28207, United States

Location

Neem Research Group, Inc.

Charlotte, North Carolina, 28262, United States

Location

Cornerstone Research Care

High Point, North Carolina, United States

Location

Carolina MedTrials, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Allergy & Asthma Care Center

Fargo, North Dakota, 58104, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45241, United States

Location

Optimed Research LLC

Columbus, Ohio, 43235, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy, Asthma and Dermatology Research Center

Lake Oswego, Oregon, 97035, United States

Location

Medford Medical Clinic, LLP

Medford, Oregon, 97504, United States

Location

Bellevue Pediatric Associates

Bellevue, Pennsylvania, 15202, United States

Location

Valley Clinical Research Center

Easton, Pennsylvania, 18045, United States

Location

Allergy & Asthma Research of NJ, Inc.

Philadelphia, Pennsylvania, 19115, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Advanced Clinical Concepts

Shillington, Pennsylvania, 19607, United States

Location

Neem Research Group of Charleston

Charleston, South Carolina, 29407, United States

Location

Neem Research Group Inc.

Columbia, South Carolina, 29201, United States

Location

Allergic Disease & Asthma Center, PA

Greenville, South Carolina, 29607, United States

Location

Asthma Institute

Chattanooga, Tennessee, 37421, United States

Location

The Allergy Associates

Knoxville, Tennessee, 37917, United States

Location

Office of Constantine Saadeh

Amarillo, Texas, 79106, United States

Location

Allergy & Asthma Clinical of Central Texas

Austin, Texas, 78749, United States

Location

UTX Medical

Galveston, Texas, 00000, United States

Location

Breco Research

Houston, Texas, 77024, United States

Location

Breath of Life Research Institute

Houston, Texas, 77054, United States

Location

Clinical Trials of North Houston

Houston, Texas, 77070, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Lung Diagnostics

San Antonio, Texas, 78229, United States

Location

Hampton Roads Center for Clinical Research

Norfolk, Virginia, 23502, United States

Location

Pulmonary Associates of Richmond Inc.

Richmond, Virginia, 23225, United States

Location

Virginia Adult & Pediatric Allergy & Asthma PC

Richmond, Virginia, 23229, United States

Location

National Clinical Research

Richmond, Virginia, 23294, United States

Location

The Physician's Clinic of Spokane

Spokane, Washington, 99204, United States

Location

Allergy, Asthma, and Sinus Center F.C.

Greenfield, Wisconsin, 53228, United States

Location

Milwaukee Medical Clinic

Milwaukee, Wisconsin, 53209, United States

Location

Allergic Diseases, S.C.

West Allis, Wisconsin, 53227, United States

Location

Trial Management Group

Vancouver, British Columbia, V5K 1Z9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Clinical Research Group

Mississauga, Ontario, L5B 1N1, Canada

Location

Niagara Clinical Research, Inc.

Niagara Falls, Ontario, L2E 7H1, Canada

Location

Primary Care Lung Clinic

Toronto, Ontario, M6H 3M2, Canada

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: January 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (91); CA (5)