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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064389
• Other study ID #: 051-356
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: February 21, 2012
• Start date: January 2003
• Est. completion date: July 2005

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Canada	Clinical Research Group	Mississauga	Ontario
Canada	Niagara Clinical Research, Inc.	Niagara Falls	Ontario
Canada	Primary Care Lung Clinic	Toronto	Ontario
Canada	Trial Management Group	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Office of Constantine Saadeh	Amarillo	Texas
United States	Regional Allergy & Asthma Consultants	Asheville	North Carolina
United States	Family Allergy & Asthma Center, PC	Atlanta	Georgia
United States	Allergy & Asthma Clinical of Central Texas	Austin	Texas
United States	Pulmonary Medical Research of NY	Bay Shore	New York
United States	Bellevue Pediatric Associates	Bellevue	Pennsylvania
United States	Jefferson Clinic PC	Birmington	Alabama
United States	Sneeze, Wheeze and Itch, LLC	Bloomington	Illinois
United States	Neem Research Group of Charleston	Charleston	South Carolina
United States	Charlotte Lung & Health Center	Charlotte	North Carolina
United States	Neem Research Group, Inc.	Charlotte	North Carolina
United States	Asthma Institute	Chattanooga	Tennessee
United States	Delaware Valley Institute for Clinical Research	Cherry Hill	New Jersey
United States	Rush Presbyterian - St. Luke's Medical Center	Chicago	Illinois
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Sterling Research Group	Cincinnati	Ohio
United States	Neem Research Group Inc.	Columbia	South Carolina
United States	Optimed Research LLC	Columbus	Ohio
United States	The Allergy & Asthma Clinic Research Center	Conyers	Georgia
United States	Integrated Research Group	Corona	California
United States	Asthma & Allergy Associates, PC	Cortland	New York
United States	Northshore Medical Research	Covington	Louisiana
United States	Office of Constantine Falliers, MD	Denver	Colorado
United States	Henry Ford Hospital & Medical Centers	Detroit	Michigan
United States	Valley Clinical Research Center	Easton	Pennsylvania
United States	Northern California Research Corp	Fair Oaks	California
United States	Allergy & Asthma Care Center	Fargo	North Dakota
United States	Hurley Child and Adolescent Asthma Center	Flint	Michigan
United States	Office of Gary Richmond, MD	Ft. Lauderdale	Florida
United States	CNS Clinical Trials	Ft. Myers	Florida
United States	UTX Medical	Galveston	Texas
United States	Children's Asthma Respiratory & Exercise Specialists	Glenview	Illinois
United States	Allergy, Asthma, and Sinus Center F.C.	Greenfield	Wisconsin
United States	Allergic Disease & Asthma Center, PA	Greenville	South Carolina
United States	Cornerstone Research Care	High Point	North Carolina
United States	Breath of Life Research Institute	Houston	Texas
United States	Breco Research	Houston	Texas
United States	Clinical Trials of North Houston	Houston	Texas
United States	Clinical Research Center of Indiana	Indianapolis	Indiana
United States	Allergy, Asthma, Immunology Services, LLC	Jefferson City	Missouri
United States	FPA Clinical Research	Kissimmee	Florida
United States	The Allergy Associates	Knoxville	Tennessee
United States	Allergy, Asthma and Dermatology Research Center	Lake Oswego	Oregon
United States	Allergy, Asthma & Immunology Associates, PC	Lincoln	Nebraska
United States	Allergy, Asthma & Respiratory Care Center	Long Beach	California
United States	Orlando Clinic for Asthma & Respiratory Diseases	Longwood	Florida
United States	Allergy & Asthma of Northern NM	Los Alamos	New Mexico
United States	Madera Family Medical Group	Madera	California
United States	Medford Medical Clinic, LLP	Medford	Oregon
United States	Allergy Sinus Asthma Research Institute	Miami	Florida
United States	Florida Center for Alergy & Asthma Research	Miami	Florida
United States	Milwaukee Medical Clinic	Milwaukee	Wisconsin
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Montana Medical Research, LLC	Missoula	Montana
United States	Pulmonary Associates Research Division	Mobile	Alabama
United States	Montgomery Pulmonary Consultants	Montgomery	Alabama
United States	Central Texas Health Research	New Braunfels	Texas
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	Consultants in Pulmonary Medicine	Olathe	Kansas
United States	Heartland Clinical Research Inc.	Omaha	Nebraska
United States	Office of Meera Dewan, MD	Omaha	Nebraska
United States	Clinical Trials of Orange County, Inc.	Orange	California
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Center of Research Excellence, LLC	Oxford	Alabama
United States	Allergy & Asthma Research of NJ, Inc.	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Lovelace Scientific Resources	Phoenix	Arizona
United States	National Clinical Research	Richmond	Virginia
United States	Pulmonary Associates of Richmond Inc.	Richmond	Virginia
United States	Virginia Adult & Pediatric Allergy & Asthma PC	Richmond	Virginia
United States	Lung Diagnostics	San Antonio	Texas
United States	Institute of Healthcare Assessment, Inc.	San Diego	California
United States	Aeroallergy Research	Savannah	Georgia
United States	Advanced Clinical Concepts	Shillington	Pennsylvania
United States	South Bend Clinic	South Bend	Indiana
United States	The Physician's Clinic of Spokane	Spokane	Washington
United States	Cardinal Respiratory, PC	Springfield	Illinois
United States	Midwest Chest Consultants, PC	St. Charles	Missouri
United States	Washington University School of Medicine, Division of Allergy & Immunology	St. Louis	Missouri
United States	Office of Michael Marcus, MD	Staten Island	New York
United States	Center for Clinical Research	Taunton	Massachusetts
United States	Clinical Research Center of Allergy & Asthma Consultants	Tinton Falls	New Jersey
United States	Office of Richard Castaldo	Tonawanda	New York
United States	Alta Clinical Research, LLC	Tucson	Arizona
United States	Allergic Diseases, S.C.	West Allis	Wisconsin
United States	Westlake Medical Research, Inc.	Westlake Village	California
United States	Institute for Asthma & Allergy, PC	Wheaton	Maryland
United States	Heartland Research Associates	Wichita	Kansas
United States	Carolina MedTrials, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of post-randomization adverse events		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53	Yes
Secondary	rate of discontinuations due to adverse events		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53	Yes
Secondary	time-to-selected adverse events (AEs with an incidence =5%)		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53	Yes
Secondary	asthma attacks, asthma adverse events, and expanded-definition asthma events		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53	Yes
Secondary	clinical laboratory values		Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53	No
Secondary	vital signs (blood pressure, heart rate, respiration rate, and body temperature)		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53	No
Secondary	ECG parameters		Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53	Yes
Secondary	physical examinations		Weeks -1, 0, 26, 27, 52, 53	No
Secondary	rescue medication, and daytime asthma control days		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53	Yes
Secondary	FEV1, FVC, FEF25-75%, peak expiratory flow		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53	No
Secondary	Asthma Quality of Life Questionnaire (AQLQ)		Weeks 0, 26, 27, 52, 53	No
Secondary	subject and physician global evaluations		Weeks 26, 27, 52, 53	No
Secondary	(S) and (R) albuterol plasma concentrations		Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53	No
Secondary	subject assessment of study inhaler device performance		Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53	No