Status:
COMPLETED
Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent a...
Detailed Description
This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (v...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Willing and able to comply with the study procedures and visit schedules
- Male or female, at least 12 years of age
- Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.
- Women of child bearing potential must be using an acceptable method of birth control
- Have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 months prior to study start
- 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
- Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
- Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, and demonstrate how to use the MiniWright PEF meter.
- Exclusion Criteria
- Female subject who is pregnant or lactating
- Have 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 taking the first daily dose of study medication and/or starting study visits before 9 AM
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance
- Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery
- Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations
- Subject using any prescription drug with which albuterol sulfate administration 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT00073827
Start Date
May 1 2002
End Date
January 1 2003
Last Update
February 22 2012
Active Locations (63)
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1
Alabama Asthma and Allergy Center
Homewood, Alabama, United States, 35209
2
MDC Research
Mobile, Alabama, United States, 36607
3
Integrated Research Group
Corona, California, United States, 92879
4
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Danville, California, United States, 94526