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

NCT00268723 | Completed Phase 3

• 1 other identifier: 051-925
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Exercise-induced Bronchospasm

Outcome Measures

Primary Outcomes (1)

• maximum percent FEV1 decrease from visit postdose/prechallenge

  Days 1, 4, 7

Secondary Outcomes (6)

• FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)

  Days 1, 4, 7

• time to FEV1 recovery

  Days 1, 4, 7

• minimum percent change in FEV1 from visit postdose/prechallenge

  Days 1, 4, 7

• minimum percent change in FEV1 from visit predose

  Days 1, 4, 7

• protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)

  Days 1, 4, 7

Study Arms (2)

1

EXPERIMENTAL

levalbuterol HFA MDI 90 mcg QID

Drug: Levalbuterol tartrate HFA MDI

2

PLACEBO COMPARATOR

Placebo MDI QID

Drug: Placebo

Interventions

Levalbuterol tartrate HFA MDI DRUG

levalbuterol MDI 90 mcg QID

Also known as: Xopenex MDI

1

Placebo DRUG

Placebo MDI QID

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (2)

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Burke, Virginia, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 22, 2005
• Study Start: December 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (2)