Clinical trial NCT01747629: Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
dry powder inhaler
short-acting beta2-agonist
SABA
bronchoconstriction
bronchodilation
bronchodilator
metered dose inhaler
Albuterol Spiromax®
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 160
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: The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.


Eligibility 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.

Primary outcomes:
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
timeFrame: Day 1, Day 8 and Day 85
Secondary outcomes:
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
timeFrame: Day 1
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
timeFrame: Day 8
measure: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
timeFrame: Day 85
measure: Participants With Adverse Events
timeFrame: Day 1 to Day 93
measure: Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
timeFrame: Day 1 (Baseline), Day 85
measure: Participants With Clinically Significant Vital Sign Assessments
timeFrame: Days 8 and 85
measure: Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8
timeFrame: Days 1 and 8
measure: Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8
timeFrame: Days 1 and 8
measure: 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
timeFrame: Days 1 and 8
measure: 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
timeFrame: Days 1 and 8
measure: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1
timeFrame: Day 1
measure: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8
timeFrame: Day 8
measure: Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8
timeFrame: Days 1 and 8
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Teva Investigational Site 10225
state: California
city: Encinitas
country: United States
facility: Teva Investigational Site 10250
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10230
state: California
city: Palmdale
country: United States
facility: Teva Investigational Site 10255
state: California
city: Rancho Mirage
country: United States
facility: Teva Investigational Site 10231
state: California
city: Riverside
country: United States
facility: Teva Investigational Site 10252
state: California
city: Rolling Hills Estates
country: United States
facility: Teva Investigational Site 10242
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10238
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 10243
state: California
city: Miami Lakes
country: United States
facility: Teva Investigational Site 10247
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 10239
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 10234
state: Florida
city: Bangor
country: United States
facility: Teva Investigational Site 10253
state: Maine
city: Baltimore
country: United States
facility: Teva Investigational Site 10257
state: Maryland
city: White Marsh
country: United States
facility: Teva Investigational Site 10254
state: Maryland
city: Fall River
country: United States
facility: Teva Investigational Site 10235
state: Massachusetts
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10236
state: Massachusetts
city: Minneapolis
country: United States
facility: Teva Investigational Site 10226
state: Minnesota
city: Minneapolis
country: United States
facility: Teva Investigational Site 10233
state: Minnesota
city: St. Louis
country: United States
facility: Teva Investigational Site 10241
state: Missouri
city: Bellevue
country: United States
facility: Teva Investigational Site 10229
state: Nebraska
city: Rochester
country: United States
facility: Teva Investigational Site 10227
state: New York
city: Charlotte
country: United States
facility: Teva Investigational Site 10244
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 10248
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10249
state: Oklahoma
city: Eugene
country: United States
facility: Teva Investigational Site 10232
state: Oregon
city: Medford
country: United States
facility: Teva Investigational Site 10259
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10237
state: Oregon
city: Bethlehem
country: United States
facility: Teva Investigational Site 10240
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 10246
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 10256
state: Pennsylvania
city: Rock Hill
country: United States
facility: Teva Investigational Site 10251
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 10228
state: South Carolina
city: San Antonio
country: United States
facility: Teva Investigational Site 10258
state: Texas
city: Seattle
country: United States
facility: Teva Investigational Site 10245
state: Washington
Study officials:
affiliation: Teva Respiratory R&D
name: Clinical Project Leader
role: STUDY_DIRECTOR
References:
citation: Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.