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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: levalbuterol tartrate HFA MDI Drug: racemic albuterol	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

Resource links provided by NLM:

Drug Information available for: Albuterol Levalbuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

incidence of post-randomization adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rate of discontinuations due to adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
time-to-selected adverse events (AEs with an incidence ≥5%) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
asthma attacks, asthma adverse events, and expanded-definition asthma events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
clinical laboratory values [ Time Frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
vital signs (blood pressure, heart rate, respiration rate, and body temperature) [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
ECG parameters [ Time Frame: Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: Yes ]
physical examinations [ Time Frame: Weeks -1, 0, 26, 27, 52, 53 ] [ Designated as safety issue: No ]
rescue medication, and daytime asthma control days [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
FEV1, FVC, FEF25-75%, peak expiratory flow [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Weeks 0, 26, 27, 52, 53 ] [ Designated as safety issue: No ]
subject and physician global evaluations [ Time Frame: Weeks 26, 27, 52, 53 ] [ Designated as safety issue: No ]
(S) and (R) albuterol plasma concentrations [ Time Frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
subject assessment of study inhaler device performance [ Time Frame: 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 ] [ Designated as safety issue: No ]


Enrollment:	746
Study Start Date:	January 2003
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 levalbuterol 90 mcg MDI QID	Drug: levalbuterol tartrate HFA MDI levalbuterol MDI 90 mcg QID Other Name: Xopenex HFA MDI
Active Comparator: 2 racemic albuterol HFA MDI 180 mcg QID	Drug: racemic albuterol racemic albuterol HFA MDI 180 mcg QID

Detailed 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.

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064389

Show 96 Study Locations

Sponsors and Collaborators

Sunovion

More Information


Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00064389 History of Changes
Other Study ID Numbers:	051-356
Study First Received:	July 8, 2003
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Bronchodilator Agents Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016