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Study of Levalbuterol, Racemic Albuterol and Placebo 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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
John Hanrahan, M.D., Study Chair, Affiliation: Sunovion

Summary

The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Clinical Details

Official title: An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: FEV1 (peak percent change from pre-dose averaged over the double-blind period).

Secondary outcome: --FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve]

Detailed description: A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment groups. 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

- Must give written informed consent (IC) prior to participation in the study. For

subjects 12 - 17 years of age, the IC must be signed parent or legal guardian.

Females must sign the Women of Childbearing Potential Addendum

- Be willing and able to comply with the study procedures and visit schedules

- Male or female, at least 12 years of age

- Females 12-60 years of age must have a negative serum pregnancy test at Visit 1 (V1)

- Women of child bearing potential must be using an acceptable method of birth control

- Must have a documented diagnosis of asthma for a min. of 6 mos. prior to V1

- At V1, the subject must demonstrate a baseline FEV1 within >45% and <75% of predicted

for their height, age, gender, and race

- Following abstention from medications used to treat asthma, subject must demonstrate

>12% reversibility of airflow obstruction within 15-30 min. following inhalation of 180 µg (2 actuations, 90 µg ea.) of racemic albuterol MDI

- 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 mos. prior to V1

- 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 and demonstrate how to use the MiniWright PEF meter Exclusion Criteria

- Subject who is expected to require any disallowed medications

- Female subject who is pregnant or lactating

- Subject who has participated in an investigational drug study within 30 days prior to

V1, or who is currently participating in another clinical trial

- Schedule prevents him or her from taking the first daily dose of study medication

and/or starting study visits before 9AM

- Subject who has travel commitments during the study that would interfere with trial

measurements or compliance or both

- Subject who has a history of hospitalization for asthma within 45 days prior to V1,

or who is scheduled for in-patient hospitalization during the trial

- Have 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 administration is

contraindicated

- Subject with currently diagnosed life-threatening asthma

- Subject with clinically significant abnormalities that may interfere with the

metabolism or excretion of the study drug

- Have a history of cancer (exception: basal cell carcinoma in remission)

- Have hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders

not well controlled by medication or that may interfere with the successful completion of this protocol

- Have a history of substance or drug abuse within 12 mos. preceding V1 or a positive

urine drug screening at V1

- Have greater than 10 pack year history of cigarette smoking or use of any tobacco

products within 6 mos. of V1

- Have a 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 V1

- Have any clinically significant abnormal laboratory values

- Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject's

ability to complete study

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

Locations and Contacts

Allergy & Asthma Center, LLC, Oxford, Alabama 36203, United States

Alta Clinical Research, Tucson, Arizona 85745, United States

Integrated Research Group, Corona, California 92879, United States

Radiant Research, Inc., Encinitas, California 92024, United States

Allergy & Asthma Specialists Medical Group, Huntington Beach, California 92647, United States

Asthma, Allergy & Respiratory Care Center, Long Beach, California 90808, United States

Allergy Research Foundation, Inc., Los Angeles, California 90025, United States

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

Southern California Research, Mission Viejo, California 92691, United States

Comprehensive Allergy Services, Oakland, California 94609, United States

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

Allergy & Asthma Medical Group & Research Center, San Diego, California 92123, United States

Allergy Associates Medical Group, San Diego, California 92120, United States

Allergy & Asthma Assoc. of Santa Clara Valley Research Center, San Jose, California 95117, United States

West Coast Clinical Trials, Signal Hill, California 90755, United States

Allergy & Asthma Medical Group of Diablo Valley, Inc., Walnut Creek, California 94598, United States

1st Allergy & Asthma Clinical Research Ctr, Thornton, Colorado 80233, United States

Watts Medical Research, Barnesville, Georgia 30204, United States

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

Aeroallergy Research Laboratories of Savannah, Inc., Savannah, Georgia 31406, United States

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

South Bend Clniic, South Bend, Indiana 46617, United States

Clinical Research Specialist, Metairie, Louisiana 70006, United States

Doctor's Care, New Orleans, Louisiana 70122, United States

Children's International Medical Research, Slidell, Louisiana 70458, United States

Clinical Research Institute, Minneapolis, Minnesota 55402, United States

The Clinical Research Center, LLC, St. Louis, Missouri 63141, United States

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

Asthma & Allergy Center PC, Papillion, Nebraska 68046, United States

Office of Yekaterina Khronusova, MD, Las Vegas, Nevada 89119, United States

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

Asthma & Allergy Associates PC, Cortland, New York 13046, United States

AAIR Research Center, Rochester, New York 14618, United States

Office or Richard Castaldo, MD, Tonawanda, New York 14150, United States

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

Albermarle Allergy & Asthma PC, Elizabeth City, North Carolina 27909, United States

Piedmont Medical Research, Winston-Salem, North Carolina 27103, United States

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

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

Allergy Associates Research Center, LLC, Portland, Oregon 97213, United States

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

Advanced Clinical Concepts, Temple, Pennsylvania 19560, United States

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

Allergy & Asthma Consultants, LLP, Mt. Pleasant, South Carolina 29464, United States

Allergy and Asthma Clinic of Central Texas, Austin, Texas 78749, United States

Research Across America, Dallas, Texas 75234, United States

Breath of Life Research Institute, Houston, Texas 77084, United States

Breco Research, Houston, Texas 77024, United States

Lung Diagnostics, San Antonio, Texas 78229, United States

PI - Coor Clinical Research, LLC, Burke, Virginia 22015, United States

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

Rockwood Clinics, PS, Spokane, Washington 99220, United States

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

Allergic Diseases, SC, West Allis, Wisconsin 53227, United States

Additional Information

Patient's Instructions for Use

Starting date: December 2002
Last updated: February 21, 2012

Page last updated: August 23, 2015

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