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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073827
• Other study ID #: 051-353
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2003
• Last updated: February 21, 2012
• Start date: May 2002
• Est. completion date: January 2003

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• levalbuterol tartrate MDI
levalbuterol 90 mcg QID
• racemic albuterol MDI
racemic albuterol 180 mcg QID
• Placebo
Placebo MDI QID

Locations

Country	Name	City	State
United States	PCCS	Albany	New York
United States	Office of Constantine Saadeh	Amarillo	Texas
United States	Regional Allergy & Asthma Consultants	Asheville	North Carolina
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Radiant Research	Charleston	South Carolina
United States	Asthma & Allergy Research Associates	Chester	Pennsylvania
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	Office of Clinical Research, University of Missouri-Columbia	Columbia	Missouri
United States	Integrated Research Group	Corona	California
United States	Allergy & Asthma Research Associates	Dallas	Texas
United States	Allergy & Asthma Medical Group of Diablo Valley, Inc.	Danville	California
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Radiant Research, Inc.	Encinitas	California
United States	Clinical Research Centers of Colorado PC	Englewood	Colorado
United States	Allergy & Asthma Research	Eugene	Oregon
United States	North Texas Institute for Clinical Trials	Fort Worth	Texas
United States	Office of Neil Kao	Greenville	South Carolina
United States	Cornerstone Research Care	High Point	North Carolina
United States	Alabama Asthma and Allergy Center	Homewood	Alabama
United States	Radiant Research Honolulu	Honolulu	Hawaii
United States	Breath of Life Research Institute	Houston	Texas
United States	Allergy & Asthma Specialists Medical Group	Huntington Beach	California
United States	Clinical Research Center of Indiana	Indianapolis	Indiana
United States	Mississippi Asthma & Allergy Clinic	Jackson	Mississippi
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	Allergy, Asthma & Respiratory Care Center	Long Beach	California
United States	Allergy Research Foundation, Inc.	Los Angeles	California
United States	Allergy & Asthma Care Specialists	Metairie	Louisiana
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	MDC Research	Mobile	Alabama
United States	Allergy & Asthma Consultants, LLP	Mt. Pleasant	South Carolina
United States	Northeast Medical Research Associates, Inc.	N. Dartmouth	Massachusetts
United States	PCHI	Needham	Massachusetts
United States	Children's Hospital of the Kings Daughters	Norfolk	Virginia
United States	Clinical Trials of Orange County	Orange	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Division of Pulmonary	Pittsburgh	Pennsylvania
United States	Allergy Associates Research Center, LLC	Portland	Oregon
United States	Princeton Center for Clinical Research	Princeton	New Jersey
United States	Asthma & Allergy Associates, PC	Pueblo	Colorado
United States	Raleigh Pediatric Associates	Raleigh	North Carolina
United States	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia
United States	AAIR Research Center	Rochester	New York
United States	Lung Diagnostics	San Antonio	Texas
United States	Allergy & Asthma Medical Group & Research Center	San Diego	California
United States	Allergy & Asthma Prevention & Treatment Center	San Diego	California
United States	Allergy Associates Medical Group	San Diego	California
United States	Allergy & Asthma Assoc. of Santa Clara Valley Research Center	San Jose	California
United States	Aeroallergy Research Laboratories of Savannah, Inc.	Savannah	Georgia
United States	ASTHMA, Inc.	Seattle	Washington
United States	Northshore Medical Research	Slidell	Louisiana
United States	Pulmonary and Allergy Associates	Springfield	New Jersey
United States	Division of Allergy & Immunology, Washington Univ School of Med	St. Louis	Missouri
United States	St. Louis University	St. Louis	Missouri
United States	The Clinical Research Center, LLC	St. Louis	Missouri
United States	Bensch Research Associates	Stockton	California
United States	Office of Ronald Saff	Tallahassee	Florida
United States	Center for Clinical Research	Taunton	Massachusetts
United States	Southern California Research Center	Viejo	California
United States	Allergy & Asthma Center	Waco	Texas
United States	Allergic Diseases, SC	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent change in FEV1 from visit predose averaged over the 8-week double-blind period		Weeks 0, 4, 8	No
Secondary	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	No
Secondary	peak percent change in FEV1 from study baseline		Weeks 0, 4, 8	No
Secondary	peak change in FEV1 from visit predose		Weeks 0, 4, 8	No
Secondary	peak percent of predicted FEV1		Weeks 0, 4, 8	No
Secondary	area under the FEV1 curve (AUC)		Weeks 0, 4, 8	No
Secondary	peak change and peak percent change in FEF25-75% from visit predose		Weeks 0, 4, 8	No
Secondary	peak change and peak percent change in FVC from visit predose		Weeks 0, 4, 8	No