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
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Asthma
In brief
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 drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.
Key facts
- Study ID
- NCT01218009
- Run by
- Teva Branded Pharmaceutical Products R&D, Inc.
- People needed
- 331
- Starts
- 2010-10-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2015-05-20
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Teva Clinical Study Site — Scottsdale, Arizona, United States
- Teva Clinical Study Site — Los Angeles, California, United States
- Teva Clinical Study Site — San Diego, California, United States
- Teva Clinical Study Site — Centennial, Colorado, United States
- Teva Clinical Study Site — Denver, Colorado, United States
- Teva Clinical Study Site — Miami, Florida, United States
- Teva Clinical Study Site — Gainesville, Georgia, United States
- Teva Clinical Study Site — Louisville, Kentucky, United States
- Teva Clinical Study Site — Wheaton, Maryland, United States
- Teva Clinical Study Site — Minneapolis, Minnesota, United States
- Teva Clinical Study Site — Plymouth, Minnesota, United States
- Teva Clinical Study Site — St Louis, Missouri, United States
- Teva Clinical Study Site — Bellevue, Nebraska, United States
- Teva Clinical Study Site — Boys Town, Nebraska, United States
- Teva Clinical Study Site — Skillman, New Jersey, United States
- Teva Clinical Study Site — Rochester, New York, United States
- Teva Clinical Study Site — Rockville Centre, New York, United States
- Teva Clinical Study Site — High Point, North Carolina, United States
- Teva Clinical Study Site — Raleigh, North Carolina, United States
- Teva Clinical Study Site — Canton, Ohio, United States
- Teva Clinical Study Site — Cincinnati, Ohio, United States
- Teva Clinical Study Site — Sylvania, Ohio, United States
- Teva Clinical Study Site — Eugene, Oregon, United States
- Teva Clinical Study Site — Portland, Oregon, United States
- Teva Clinical Study Site — El Paso, Texas, United States
Full record on ClinicalTrials.gov
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