Status:
COMPLETED
A Safety and Tolerability Study of Levalbuterol HFA Metered Dose Inhaler in Subjects With Asthma
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI.
Detailed Description
A randomized, modified-blind active-controlled multicenter, two-way crossover study of levalbuterol compared to racemic albuterol (using a spacer) in subjects 12 years of age and older with asthma. Th...
Eligibility Criteria
Inclusion
- Subject, male or female, must be at least 12 years of age at the time of consent.
- Female subjects 12-60 years of age inclusive must have a negative serum pregnancy test at study start.
- Women of child bearing potential must be using an acceptable method of birth control throughout the study.
- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start.
- Subject 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.
- Subject must have a chest X-ray or had one within 12 months prior to randomization.
- Subject must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and be able to demonstrate good MDI administration technique. Any minor subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.
Exclusion
- Female subject who is pregnant or lactating.
- Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial.
- Subject whose schedule prevents him or her from starting study visits before 9 AM.
- 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 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of 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 administration is contraindicated.
- Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
- Subject with a history of cancer (exception: basal cell carcinoma in remission).
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
- Subject with a history of substance abuse or drug abuse within 12 months preceding study start.
- Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start.
- Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
- Subject with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
- Subject who is a staff member or relative of a staff member.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00684827
Start Date
October 1 2002
End Date
February 1 2003
Last Update
February 22 2012
Active Locations (4)
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1
Encinitas, California, United States
2
Los Angeles, California, United States
3
North Dartmouth, Massachusetts, United States
4
St Louis, Missouri, United States