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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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Placebo Spiromax (Drug); Albuterol Spiromax (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

Official(s) and/or principal investigator(s):
Clinical Project Leader, Study Director, Affiliation: Teva Respiratory R&D

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.

Clinical Details

Official title: A Multi-Center 52-Week Study to Assess the Safety of an Albuterol Dry-powder Inhaler in Subjects With Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Participants With Treatment-Emergent Adverse Events

Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator

Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator

Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator

Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Teva Clinical Study Site, New Braunfels, Texas, United States

Teva Clinical Study Site, San Antonio, Texas, United States

Teva Clinical Study Site, Burke, Virginia, United States

Teva Clinical Study Site, Seattle, Washington, United States

Teva Clinical Study Site, Greenfield, Wisconsin, United States

Additional Information

Starting date: October 2010
Last updated: May 1, 2015

Page last updated: August 23, 2015

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