A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

Sponsors

Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Source Teva Pharmaceutical Industries
Brief Summary

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Overall Status Completed
Start Date December 2012
Completion Date November 2013
Primary Completion Date October 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period Day 1, Day 8 and Day 85
Secondary Outcome
Measure Time Frame
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1 Day 1
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8 Day 8
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85 Day 85
Participants With Adverse Events Day 1 to Day 92
Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group Day 1 (Baseline), Day 85
Participants With Clinically Significant Vital Sign Assessments Day 8, Day 85
Enrollment 158
Condition
Intervention

Intervention type: Drug

Intervention name: Placebo MDPI

Description: Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.

Arm group label: Placebo MDPI

Other name: Placebo Spiromax®

Intervention type: Drug

Intervention name: Albuterol MDPI

Description: Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.

Arm group label: Albuterol MDPI

Other name: ProAir® RespiClick, Albuterol Spiromax®

Eligibility

Criteria:

Inclusion Criteria:

- Written informed consent/assent

- General good health

- Persistent asthma, with an FEV1 50-80% predicted.

- Ability to perform spirometry in an acceptable manner as per protocol guidelines.

- Ability to perform PEFR with a handheld peak flow meter.

- Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.

- Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.

- Non-smokers.

- Capable of understanding the requirements, risks, and benefits of study participation.

- Other inclusion criteria apply.

Exclusion Criteria:

- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).

- 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 that has not resolved within the 2 weeks preceding the Screening Visit (SV).

- Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.

- History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.

- Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).

- Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.

- Other exclusion criteria apply.

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Project Leader Study Director Teva Respiratory R&D
Location
facility
Teva Investigational Site 10077 | Birmingham, Alabama, United States
Teva Investigational Site 10079 | Phoenix, Arizona, United States
Teva Investigational Site 10569 | Costa Mesa, California, United States
Teva Investigational Site 10053 | Fountain Valley, California, United States
Teva Investigational Site 10065 | Huntington Beach, California, United States
Teva Investigational Site 10572 | Huntington Beach, California, United States
Teva Investigational Site 10075 | Los Angeles, California, United States
Teva Investigational Site 10061 | Roseville, California, United States
Teva Investigational Site 10066 | San Diego, California, United States
Teva Investigational Site 10068 | Denver, Colorado, United States
Teva Investigational Site 10069 | Denver, Colorado, United States
Teva Investigational Site 10058 | Miami, Florida, United States
Teva Investigational Site 10060 | Miami, Florida, United States
Teva Investigational Site 10064 | Ormond Beach, Florida, United States
Teva Investigational Site 10071 | Savannah, Georgia, United States
Teva Investigational Site 10073 | Wichita, Kansas, United States
Teva Investigational Site 10070 | Owensboro, Kentucky, United States
Teva Investigational Site 10063 | Bethesda, Maryland, United States
Teva Investigational Site 10571 | Gaithersburg, Maryland, United States
Teva Investigational Site 10067 | Wheaton, Maryland, United States
Teva Investigational Site 10072 | St. Louis, Missouri, United States
Teva Investigational Site 10050 | Missoula, Montana, United States
Teva Investigational Site 10057 | Raleigh, North Carolina, United States
Teva Investigational Site 10051 | Cincinnati, Ohio, United States
Teva Investigational Site 10078 | Sylvania, Ohio, United States
Teva Investigational Site 10054 | Oklahoma City, Oklahoma, United States
Teva Investigational Site 10568 | Oklahoma City, Oklahoma, United States
Teva Investigational Site 10055 | Tulsa, Oklahoma, United States
Teva Investigational Site 10056 | Medford, Oregon, United States
Teva Investigational Site 10076 | Medford, Oregon, United States
Teva Investigational Site 10684 | Charleston, South Carolina, United States
Teva Investigational Site 10570 | Spartanburg, South Carolina, United States
Teva Investigational Site 10049 | Live Oak, Texas, United States
Teva Investigational Site 10052 | San Antonio, Texas, United States
Teva Investigational Site 10685 | Waco, Texas, United States
Teva Investigational Site 10059 | Fairfax, Virginia, United States
Teva Investigational Site 10074 | Puyallup, Washington, United States
Teva Investigational Site 10062 | Tacoma, Washington, United States
Location Countries

United States

Verification Date

May 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Placebo MDPI

Arm group type: Placebo Comparator

Description: Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.

Arm group label: Albuterol MDPI

Arm group type: Experimental

Description: Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov