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Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB

Primary Purpose

Exercise-induced Bronchospasm

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levalbuterol tartrate HFA MDI
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise-induced Bronchospasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Subjects were males or females and 18 years of age or older at the time of consent. Female subjects considered not of childbearing potential were either surgically sterile or greater than one-year postmenopausal, defined as a complete cessation of menstruation for at least one year. Female subjects of child-bearing potential had a negative urine pregnancy test at screening. Female subjects of child-bearing potential agreed to use an acceptable method of birth control throughout the study. Subjects were in good health and were not suffering from any chronic condition that might affect their respiratory or cardiac function (including cardiac arrhythmias). Subjects had a documented diagnosis of exercise-induced bronchospasm for a minimum of 6 months prior to study start. Subjects had stable baseline asthma and had been using a beta2-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to study start. Exclusion Criteria Subjects with currently diagnosed life-threatening asthma defined as a history of: asthma episodes requiring intubation, associated hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start. Subjects with a history of hospitalization for asthma within 4 weeks prior to study start, or who were scheduled for in-patient hospitalization, including elective surgery, during the course of the trial. Subjects with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis. Subjects who suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start. Subjects with any clinically significant unstable medical abnormality, chronic disease (other than asthma), or history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, renal, endocrine, or central nervous systems that was not currently well controlled by medication or that may have interfered with the successful completion of the protocol. Subjects with a history of cancer (exception: basal-cell carcinoma in remission for a minimum of 5 years). Subjects with a known sensitivity to levalbuterol, racemic albuterol, or any of the excipients contained in any of these formulations. Subjects using any prescription drug with which levalbuterol tartrate administration is contraindicated. Subjects with a history of substance abuse or drug abuse within 12 months preceding study start. Subjects who participated in an investigational drug study within 30 days prior to study start, or who were currently participating in another clinical trial. Subjects with a greater than 10-pack-year history of cigarette smoking or use of any tobacco products within 6 months of study start. Subject was a staff member or relative of a staff member. Subjects with unstable asthma, or had a change in asthma therapy, or a visit to the emergency department or hospital for worsening asthma within 4 weeks of study start.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

levalbuterol HFA MDI 90 mcg QID

Placebo MDI QID

Outcomes

Primary Outcome Measures

maximum percent FEV1 decrease from visit postdose/prechallenge

Secondary Outcome Measures

FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)
time to FEV1 recovery
minimum percent change in FEV1 from visit postdose/prechallenge
minimum percent change in FEV1 from visit predose
protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)
percent change in FEV1 from predose to postdose/prechallenge

Full Information

First Posted
December 20, 2005
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00268723
Brief Title
Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB
Official Title
An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
Detailed Description
This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Bronchospasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
levalbuterol HFA MDI 90 mcg QID
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo MDI QID
Intervention Type
Drug
Intervention Name(s)
Levalbuterol tartrate HFA MDI
Other Intervention Name(s)
Xopenex MDI
Intervention Description
levalbuterol MDI 90 mcg QID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo MDI QID
Primary Outcome Measure Information:
Title
maximum percent FEV1 decrease from visit postdose/prechallenge
Time Frame
Days 1, 4, 7
Secondary Outcome Measure Information:
Title
FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)
Time Frame
Days 1, 4, 7
Title
time to FEV1 recovery
Time Frame
Days 1, 4, 7
Title
minimum percent change in FEV1 from visit postdose/prechallenge
Time Frame
Days 1, 4, 7
Title
minimum percent change in FEV1 from visit predose
Time Frame
Days 1, 4, 7
Title
protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)
Time Frame
Days 1, 4, 7
Title
percent change in FEV1 from predose to postdose/prechallenge
Time Frame
Days 1, 4, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects were males or females and 18 years of age or older at the time of consent. Female subjects considered not of childbearing potential were either surgically sterile or greater than one-year postmenopausal, defined as a complete cessation of menstruation for at least one year. Female subjects of child-bearing potential had a negative urine pregnancy test at screening. Female subjects of child-bearing potential agreed to use an acceptable method of birth control throughout the study. Subjects were in good health and were not suffering from any chronic condition that might affect their respiratory or cardiac function (including cardiac arrhythmias). Subjects had a documented diagnosis of exercise-induced bronchospasm for a minimum of 6 months prior to study start. Subjects had stable baseline asthma and had been using a beta2-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to study start. Exclusion Criteria Subjects with currently diagnosed life-threatening asthma defined as a history of: asthma episodes requiring intubation, associated hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start. Subjects with a history of hospitalization for asthma within 4 weeks prior to study start, or who were scheduled for in-patient hospitalization, including elective surgery, during the course of the trial. Subjects with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis. Subjects who suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start. Subjects with any clinically significant unstable medical abnormality, chronic disease (other than asthma), or history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, renal, endocrine, or central nervous systems that was not currently well controlled by medication or that may have interfered with the successful completion of the protocol. Subjects with a history of cancer (exception: basal-cell carcinoma in remission for a minimum of 5 years). Subjects with a known sensitivity to levalbuterol, racemic albuterol, or any of the excipients contained in any of these formulations. Subjects using any prescription drug with which levalbuterol tartrate administration is contraindicated. Subjects with a history of substance abuse or drug abuse within 12 months preceding study start. Subjects who participated in an investigational drug study within 30 days prior to study start, or who were currently participating in another clinical trial. Subjects with a greater than 10-pack-year history of cigarette smoking or use of any tobacco products within 6 months of study start. Subject was a staff member or relative of a staff member. Subjects with unstable asthma, or had a change in asthma therapy, or a visit to the emergency department or hospital for worsening asthma within 4 weeks of study start.
Facility Information:
City
Denver
State/Province
Colorado
Country
United States
City
Burke
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB

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