Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Branded Pharmaceutical Products R&D, Inc.
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 days with the majority of subjects receiving ≤30 days of double-blind treatment.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
