Status:
TERMINATED
A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy dru...
Detailed Description
The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49...
Eligibility Criteria
Inclusion
- Documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening.
- Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration
- General good health
- Capable of understanding the requirements, risks, and benefits of study participation
- Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years
- Other criteria apply
Exclusion
- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit
- Participation in any investigational drug trial within 30 days preceding the screening visit
- A known hypersensitivity to albuterol or any of the excipients in the formulations.
- History of severe milk protein allergy
- History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit.
- Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications
- Inability to tolerate or unwillingness to comply with the protocol requirements.
- History of life-threatening asthma
- Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids
- History of life-threatening asthma
- Other criteria apply
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01218009
Start Date
October 1 2010
End Date
December 1 2010
Last Update
May 20 2015
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Teva Clinical Study Site
Scottsdale, Arizona, United States
2
Teva Clinical Study Site
Los Angeles, California, United States
3
Teva Clinical Study Site
San Diego, California, United States
4
Teva Clinical Study Site
Centennial, Colorado, United States