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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: levalbuterol tartrate HFA MDI (Drug); racemic albuterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: incidence of post-randomization adverse events

Secondary outcome:

rate of discontinuations due to adverse events

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

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

clinical laboratory values

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

ECG parameters

physical examinations

rescue medication, and daytime asthma control days

FEV1, FVC, FEF25-75%, peak expiratory flow

Asthma Quality of Life Questionnaire (AQLQ)

subject and physician global evaluations

(S) and (R) albuterol plasma concentrations

subject assessment of study inhaler device performance

Detailed description: This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a >30-day washout) were considered to be de novo subjects. Study participation included 10 study visits over a 12 month period. 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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- 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 Exclusion Criteria

- 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

- Subject who is a staff member or relative of a staff member

Locations and Contacts

Jefferson Clinic PC, Birmington, Alabama 35233, United States

Pulmonary Associates Research Division, Mobile, Alabama 36608, United States

Montgomery Pulmonary Consultants, Montgomery, Alabama 36111, United States

Center of Research Excellence, LLC, Oxford, Alabama 36203, United States

Lovelace Scientific Resources, Phoenix, Arizona 85016, United States

Alta Clinical Research, LLC, Tucson, Arizona 85745, United States

Trial Management Group, Vancouver, British Columbia V5K 1Z9, Canada

Integrated Research Group, Corona, California 92506, United States

Northern California Research Corp, Fair Oaks, California 95628, United States

Allergy, Asthma & Respiratory Care Center, Long Beach, California 90806, United States

Madera Family Medical Group, Madera, California 93637, United States

Clinical Trials of Orange County, Inc., Orange, California 92868, United States

Institute of Healthcare Assessment, Inc., San Diego, California 92120, United States

Westlake Medical Research, Inc., Westlake Village, California 91361, United States

Office of Constantine Falliers, MD, Denver, Colorado 80209, United States

Office of Gary Richmond, MD, Ft. Lauderdale, Florida 33316, United States

CNS Clinical Trials, Ft. Myers, Florida 33907, United States

FPA Clinical Research, Kissimmee, Florida 34741, United States

Orlando Clinic for Asthma & Respiratory Diseases, Longwood, Florida 32750, United States

Allergy Sinus Asthma Research Institute, Miami, Florida 33173, United States

Florida Center for Alergy & Asthma Research, Miami, Florida 33176, United States

Orlando Clinical Research Center, Orlando, Florida 32806, United States

Family Allergy & Asthma Center, PC, Atlanta, Georgia 30342, United States

The Allergy & Asthma Clinic Research Center, Conyers, Georgia 30013, United States

Aeroallergy Research, Savannah, Georgia 31046, United States

Sneeze, Wheeze and Itch, LLC, Bloomington, Illinois 61761, United States

Rush Presbyterian - St. Luke's Medical Center, Chicago, Illinois 60612, United States

Children's Asthma Respiratory & Exercise Specialists, Glenview, Illinois 60025, United States

Cardinal Respiratory, PC, Springfield, Illinois, United States

Clinical Research Center of Indiana, Indianapolis, Indiana 46208, United States

South Bend Clinic, South Bend, Indiana 46617, United States

Consultants in Pulmonary Medicine, Olathe, Kansas 66061, United States

Heartland Research Associates, Wichita, Kansas 67207, United States

Northshore Medical Research, Covington, Louisiana 70433, United States

St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada

Institute for Asthma & Allergy, PC, Wheaton, Maryland, United States

Center for Clinical Research, Taunton, Massachusetts 02780, United States

Henry Ford Hospital & Medical Centers, Detroit, Michigan 48202, United States

Hurley Child and Adolescent Asthma Center, Flint, Michigan 45832, United States

Clinical Research Institute, Minneapolis, Minnesota 55402, United States

Allergy, Asthma, Immunology Services, LLC, Jefferson City, Missouri 65101, United States

Midwest Chest Consultants, PC, St. Charles, Missouri 63301, United States

Washington University School of Medicine, Division of Allergy & Immunology, St. Louis, Missouri 63110, United States

Montana Medical Research, LLC, Missoula, Montana 59804, United States

Allergy, Asthma & Immunology Associates, PC, Lincoln, Nebraska 68505, United States

Heartland Clinical Research Inc., Omaha, Nebraska 68134, United States

Office of Meera Dewan, MD, Omaha, Nebraska 68144, United States

Delaware Valley Institute for Clinical Research, Cherry Hill, New Jersey 08003, United States

Clinical Research Center of Allergy & Asthma Consultants, Tinton Falls, New Jersey 07701, United States

Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States

Allergy & Asthma of Northern NM, Los Alamos, New Mexico 87544, United States

Pulmonary Medical Research of NY, Bay Shore, New York 11706, United States

Asthma & Allergy Associates, PC, Cortland, New York 13045, United States

Office of Michael Marcus, MD, Staten Island, New York 10304, United States

Office of Richard Castaldo, Tonawanda, New York 14150, United States

Regional Allergy & Asthma Consultants, Asheville, North Carolina 28801, United States

Charlotte Lung & Health Center, Charlotte, North Carolina 28207, United States

Neem Research Group, Inc., Charlotte, North Carolina 28262, United States

Cornerstone Research Care, High Point, North Carolina, United States

Carolina MedTrials, LLC, Winston-Salem, North Carolina 27103, United States

Allergy & Asthma Care Center, Fargo, North Dakota 58104, United States

New Horizons Clinical Research, Cincinnati, Ohio 45241, United States

Sterling Research Group, Cincinnati, Ohio 45219, United States

Optimed Research LLC, Columbus, Ohio 43235, United States

Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States

Clinical Research Group, Mississauga, Ontario L5B 1N1, Canada

Niagara Clinical Research, Inc., Niagara Falls, Ontario L2E 7H1, Canada

Primary Care Lung Clinic, Toronto, Ontario M6H 3M2, Canada

Allergy, Asthma and Dermatology Research Center, Lake Oswego, Oregon 97035, United States

Medford Medical Clinic, LLP, Medford, Oregon 97504, United States

Bellevue Pediatric Associates, Bellevue, Pennsylvania 15202, United States

Valley Clinical Research Center, Easton, Pennsylvania 18045, United States

Allergy & Asthma Research of NJ, Inc., Philadelphia, Pennsylvania 19115, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Advanced Clinical Concepts, Shillington, Pennsylvania 19607, United States

Neem Research Group of Charleston, Charleston, South Carolina 29407, United States

Neem Research Group Inc., Columbia, South Carolina 29201, United States

Allergic Disease & Asthma Center, PA, Greenville, South Carolina 29607, United States

Asthma Institute, Chattanooga, Tennessee 37421, United States

The Allergy Associates, Knoxville, Tennessee 37917, United States

Office of Constantine Saadeh, Amarillo, Texas 79106, United States

Allergy & Asthma Clinical of Central Texas, Austin, Texas 78749, United States

UTX Medical, Galveston, Texas 00000, United States

Breath of Life Research Institute, Houston, Texas 77054, United States

Breco Research, Houston, Texas 77024, United States

Clinical Trials of North Houston, Houston, Texas 77070, United States

Central Texas Health Research, New Braunfels, Texas 78130, United States

Lung Diagnostics, San Antonio, Texas 78229, United States

Hampton Roads Center for Clinical Research, Norfolk, Virginia 23502, United States

National Clinical Research, Richmond, Virginia 23294, United States

Pulmonary Associates of Richmond Inc., Richmond, Virginia 23225, United States

Virginia Adult & Pediatric Allergy & Asthma PC, Richmond, Virginia 23229, United States

The Physician's Clinic of Spokane, Spokane, Washington 99204, United States

Allergy, Asthma, and Sinus Center F.C., Greenfield, Wisconsin 53228, United States

Milwaukee Medical Clinic, Milwaukee, Wisconsin 53209, United States

Allergic Diseases, S.C., West Allis, Wisconsin 53227, United States

Additional Information

Starting date: January 2003
Last updated: February 21, 2012

Page last updated: August 23, 2015

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