Clinical trial NCT01218009: 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
Official title: A Multi-Center 52-Week Study to Assess the Safety of an Albuterol Dry-powder Inhaler in Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
dry powder inhaler
short-acting beta2-agonist
SABA
bronchoconstriction
bronchodilation
bronchodilator
metered dose inhaler
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 331
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 days with the majority of subjects receiving ≤30 days of double-blind treatment.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 to Day 49 (study termination)
measure: Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator
timeFrame: Days -15 to -8 (Screening), Week 12, Week 52
measure: Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator
timeFrame: Days -15 to -8 (Screening), Week 12, Week 52
measure: Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator
timeFrame: Days -15 to -8 (Screening), Week 12, Week 52
measure: Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator
timeFrame: Days -15 to -8 (Screening), Week 12, Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Teva Clinical Study Site
state: Arizona
city: Los Angeles
country: United States
facility: Teva Clinical Study Site
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site
state: California
city: Centennial
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Denver
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Miami
country: United States
facility: Teva Clinical Study Site
state: Florida
city: Gainesville
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Louisville
country: United States
facility: Teva Clinical Study Site
state: Kentucky
city: Wheaton
country: United States
facility: Teva Clinical Study Site
state: Maryland
city: Minneapolis
country: United States
facility: Teva Clinical Study Site
state: Minnesota
city: Plymouth
country: United States
facility: Teva Clinical Study Site
state: Minnesota
city: St. Louis
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: Bellevue
country: United States
facility: Teva Clinical Study Site
state: Nebraska
city: Boys Town
country: United States
facility: Teva Clinical Study Site
state: Nebraska
city: Skillman
country: United States
facility: Teva Clinical Study Site
state: New Jersey
city: Rochester
country: United States
facility: Teva Clinical Study Site
state: New York
city: Rockville Centre
country: United States
facility: Teva Clinical Study Site
state: New York
city: High Point
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Canton
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Cincinnati
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Sylvania
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Eugene
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: Portland
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: El Paso
country: United States
facility: Teva Clinical Study Site
state: Texas
city: New Braunfels
country: United States
facility: Teva Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Burke
country: United States
facility: Teva Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: Teva Clinical Study Site
state: Washington
city: Greenfield
country: United States
facility: Teva Clinical Study Site
state: Wisconsin
Study officials:
affiliation: Teva Respiratory R&D
name: Clinical Project Leader
role: STUDY_DIRECTOR
References: