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Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

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 MDPI (Drug); Albuterol MDPI (Drug)

Phase: Phase 3

Status: Completed

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

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax versus placebo in subjects with persistent asthma.

Clinical Details

Official title: A 12-week Comparison of the Efficacy and Safety and Steady-State Pharmacokinetics of Albuterol Spiromax Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

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

Primary outcome: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period

Secondary outcome:

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85

Participants With Adverse Events

Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group

Participants With Clinically Significant Vital Sign Assessments

Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8

Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8

Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8

Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8

Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1

Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8

Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8

Eligibility

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

Criteria:

Inclusion Criteria:

- Written informed consent/assent

- At least 12 years of age at screening

- General good health

- Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility

- Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of

fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.

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

- Other inclusion criteria apply

Exclusion Criteria:

- A known hypersensitivity to albuterol or any of the excipients in the formulations.

- History of a respiratory infection or disorder that has not resolved within 1 week

preceding the Screening Visit (SV).

- 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 SV. A

subject must not have had any hospitalization for asthma within 6 months prior to the SV.

- Hospitalization due to asthma exacerbation 2 or more times in the past year

- Initiation of immunotherapy or dose escalation during the study period

- Other exclusion criteria apply.

Locations and Contacts

Teva Investigational Site 10225, Costa Mesa, California, United States

Teva Investigational Site 10250, Encinitas, California, United States

Teva Investigational Site 10230, Huntington Beach, California, United States

Teva Investigational Site 10255, Palmdale, California, United States

Teva Investigational Site 10231, Rancho Mirage, California, United States

Teva Investigational Site 10252, Riverside, California, United States

Teva Investigational Site 10242, Rolling Hills Estates, California, United States

Teva Investigational Site 10238, San Diego, California, United States

Teva Investigational Site 10243, San Jose, California, United States

Teva Investigational Site 10247, Miami Lakes, Florida, United States

Teva Investigational Site 10239, Tallahassee, Florida, United States

Teva Investigational Site 10234, Tampa, Florida, United States

Teva Investigational Site 10253, Bangor, Maine, United States

Teva Investigational Site 10257, Baltimore, Maryland, United States

Teva Investigational Site 10254, White Marsh, Maryland, United States

Teva Investigational Site 10235, Fall River, Massachusetts, United States

Teva Investigational Site 10236, North Dartmouth, Massachusetts, United States

Teva Investigational Site 10226, Minneapolis, Minnesota, United States

Teva Investigational Site 10233, Minneapolis, Minnesota, United States

Teva Investigational Site 10241, St. Louis, Missouri, United States

Teva Investigational Site 10229, Bellevue, Nebraska, United States

Teva Investigational Site 10227, Rochester, New York, United States

Teva Investigational Site 10244, Charlotte, North Carolina, United States

Teva Investigational Site 10248, Cincinnati, Ohio, United States

Teva Investigational Site 10249, Oklahoma City, Oklahoma, United States

Teva Investigational Site 10232, Eugene, Oregon, United States

Teva Investigational Site 10259, Medford, Oregon, United States

Teva Investigational Site 10237, Portland, Oregon, United States

Teva Investigational Site 10240, Bethlehem, Pennsylvania, United States

Teva Investigational Site 10246, Pittsburgh, Pennsylvania, United States

Teva Investigational Site 10256, Pittsburgh, Pennsylvania, United States

Teva Investigational Site 10251, Rock Hill, South Carolina, United States

Teva Investigational Site 10228, Spartanburg, South Carolina, United States

Teva Investigational Site 10258, San Antonio, Texas, United States

Teva Investigational Site 10245, Seattle, Washington, United States

Additional Information

Starting date: December 2012
Last updated: May 28, 2015

Page last updated: August 23, 2015

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