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: NCT00073840
• Other study ID #: 051-355
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2003
• Last updated: February 21, 2012
• Start date: December 2002
• Est. completion date: June 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• levalbuterol
Levalbuterol 90 ug QID (manufacturing sites A or B); Racemic Albuterol 180 ug QID; Placebo QID

Locations

Country	Name	City	State
United States	Allergy and Asthma Clinic of Central Texas	Austin	Texas
United States	Watts Medical Research	Barnesville	Georgia
United States	Pulmonary Medical Research of NY, PLLC	Bay Shore	New York
United States	PI - Coor Clinical Research, LLC	Burke	Virginia
United States	Charlotte Lung and Health Center	Charlotte	North Carolina
United States	Rush Presbyterian - St. Luke's Medical Center Rush University	Chicago	Illinois
United States	New Horizons Clinical Research, Inc.	Cincinnati	Ohio
United States	The Allergy & Asthma Clinical Research Center	Conyers	Georgia
United States	Integrated Research Group	Corona	California
United States	Asthma & Allergy Associates PC	Cortland	New York
United States	Research Across America	Dallas	Texas
United States	Valley Clinical Research Center	Easton	Pennsylvania
United States	Albermarle Allergy & Asthma PC	Elizabeth City	North Carolina
United States	Radiant Research, Inc.	Encinitas	California
United States	Allergy, Asthma and Sinus Center F.C.	Greenfield	Wisconsin
United States	Allergic Disease & Asthma Center PA	Greenville	South Carolina
United States	Breath of Life Research Institute	Houston	Texas
United States	Breco Research	Houston	Texas
United States	Allergy & Asthma Specialists Medical Group	Huntington Beach	California
United States	Office of Yekaterina Khronusova, MD	Las Vegas	Nevada
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	Clinical Research Specialist	Metairie	Louisiana
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Southern California Research	Mission Viejo	California
United States	Allergy & Asthma Consultants, LLP	Mt. Pleasant	South Carolina
United States	Doctor's Care	New Orleans	Louisiana
United States	Comprehensive Allergy Services	Oakland	California
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	Heartland Clinical Research Inc.	Omaha	Nebraska
United States	Clinical Trials of Orange County	Orange	California
United States	Allergy & Asthma Center, LLC	Oxford	Alabama
United States	Asthma & Allergy Center PC	Papillion	Nebraska
United States	Allergy Associates Research Center, LLC	Portland	Oregon
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 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	West Coast Clinical Trials	Signal Hill	California
United States	Children's International Medical Research	Slidell	Louisiana
United States	South Bend Clniic	South Bend	Indiana
United States	Rockwood Clinics, PS	Spokane	Washington
United States	The Clinical Research Center, LLC	St. Louis	Missouri
United States	Advanced Clinical Concepts	Temple	Pennsylvania
United States	1st Allergy & Asthma Clinical Research Ctr	Thornton	Colorado
United States	Office or Richard Castaldo, MD	Tonawanda	New York
United States	Alta Clinical Research	Tucson	Arizona
United States	Allergy & Asthma Medical Group of Diablo Valley, Inc.	Walnut Creek	California
United States	Allergic Diseases, SC	West Allis	Wisconsin
United States	Piedmont Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 (peak percent change from pre-dose averaged over the double-blind period).		8 weeks	Yes
Secondary	--FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve]		9 weeks	Yes

External Links

•   Patient's Instructions for Use