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

NCT ID: NCT00073840

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2003-06-30

Brief 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).

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

I

Levalbuterol 90 ųg QID (manufacturing site A or B)

Group Type: ACTIVE_COMPARATOR

levalbuterol

Intervention Type: DRUG

• Levalbuterol 90 ųg QID (manufacturing sites A or B);
• Racemic Albuterol 180 ųg QID;
• Placebo QID

II

Racemic Albuterol 180 ųg QID

Group Type: ACTIVE_COMPARATOR

levalbuterol

Intervention Type: DRUG

• Levalbuterol 90 ųg QID (manufacturing sites A or B);
• Racemic Albuterol 180 ųg QID;
• Placebo QID

III

Placebo QID

Group Type: PLACEBO_COMPARATOR

levalbuterol

Intervention Type: DRUG

• Levalbuterol 90 ųg QID (manufacturing sites A or B);
• Racemic Albuterol 180 ųg QID;
• Placebo QID

Interventions

levalbuterol

• Levalbuterol 90 ųg QID (manufacturing sites A or B);
• Racemic Albuterol 180 ųg QID;
• Placebo QID

Intervention Type: DRUG

Other Intervention Names

Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hanrahan, M.D.

Role: STUDY_CHAIR

Sumitomo Pharma America, Inc.

Locations

Allergy & Asthma Center, LLC

Oxford, Alabama, United States

Alta Clinical Research

Tucson, Arizona, United States

Integrated Research Group

Corona, California, United States

Radiant Research, Inc.

Encinitas, California, United States

Allergy & Asthma Specialists Medical Group

Huntington Beach, California, United States

Asthma, Allergy & Respiratory Care Center

Long Beach, California, United States

Allergy Research Foundation, Inc.

Los Angeles, California, United States

Madera Family Medical Group

Madera, California, United States

Southern California Research

Mission Viejo, California, United States

Comprehensive Allergy Services

Oakland, California, United States

Clinical Trials of Orange County

Orange, California, United States

Allergy Associates Medical Group

San Diego, California, United States

Allergy & Asthma Medical Group & Research Center

San Diego, California, United States

Allergy & Asthma Assoc. of Santa Clara Valley Research Center

San Jose, California, United States

West Coast Clinical Trials

Signal Hill, California, United States

Allergy & Asthma Medical Group of Diablo Valley, Inc.

Walnut Creek, California, United States

1st Allergy & Asthma Clinical Research Ctr

Thornton, Colorado, United States

Watts Medical Research

Barnesville, Georgia, United States

The Allergy & Asthma Clinical Research Center

Conyers, Georgia, United States

Aeroallergy Research Laboratories of Savannah, Inc.

Savannah, Georgia, United States

Rush Presbyterian - St. Luke's Medical Center Rush University

Chicago, Illinois, United States

South Bend Clniic

South Bend, Indiana, United States

Clinical Research Specialist

Metairie, Louisiana, United States

Doctor's Care

New Orleans, Louisiana, United States

Children's International Medical Research

Slidell, Louisiana, United States

Clinical Research Institute

Minneapolis, Minnesota, United States

The Clinical Research Center, LLC

St Louis, Missouri, United States

Heartland Clinical Research Inc.

Omaha, Nebraska, United States

Asthma & Allergy Center PC

Papillion, Nebraska, United States

Office of Yekaterina Khronusova, MD

Las Vegas, Nevada, United States

Pulmonary Medical Research of NY, PLLC

Bay Shore, New York, United States

Asthma & Allergy Associates PC

Cortland, New York, United States

AAIR Research Center

Rochester, New York, United States

Office or Richard Castaldo, MD

Tonawanda, New York, United States

Charlotte Lung and Health Center

Charlotte, North Carolina, United States

Albermarle Allergy & Asthma PC

Elizabeth City, North Carolina, United States

Piedmont Medical Research

Winston-Salem, North Carolina, United States

New Horizons Clinical Research, Inc.

Cincinnati, Ohio, United States

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Allergy Associates Research Center, LLC

Portland, Oregon, United States

Valley Clinical Research Center

Easton, Pennsylvania, United States

Advanced Clinical Concepts

Temple, Pennsylvania, United States

Allergic Disease & Asthma Center PA

Greenville, South Carolina, United States

Allergy & Asthma Consultants, LLP

Mt. Pleasant, South Carolina, United States

Allergy and Asthma Clinic of Central Texas

Austin, Texas, United States

Research Across America

Dallas, Texas, United States

Breco Research

Houston, Texas, United States

Breath of Life Research Institute

Houston, Texas, United States

Lung Diagnostics

San Antonio, Texas, United States

PI - Coor Clinical Research, LLC

Burke, Virginia, United States

Pulmonary Associates of Richmond, inc.

Richmond, Virginia, United States

Rockwood Clinics, PS

Spokane, Washington, United States

Allergy, Asthma and Sinus Center F.C.

Greenfield, Wisconsin, United States

Allergic Diseases, SC

West Allis, Wisconsin, United States

Countries

United States

References

Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.

Reference Type: DERIVED

PMID: 20851928 (View on PubMed)

Related Links

http://www.xopenex.com/about/patient-instructions.html

Patient's Instructions for Use

Other Identifiers

051-355

Identifier Type: -

Identifier Source: org_study_id