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

NCT01424813 | Completed Phase 3 Results

• 1 other identifier: ABS-AS-301
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 38

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.

Conditions

Asthma

Keywords

Asthma; dry powder inhaler; short-acting beta2-agonist; SABA; bronchoconstriction; bronchodilation; bronchodilator; metered dose inhaler

Outcome Measures

Primary Outcomes (1)

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

  FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.

  Day 1, Day 8 and Day 85

Secondary Outcomes (6)

• 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

Other Outcomes (15)

• Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period

  Day 1, Day 8, Day 85

• Percent Change From Baseline in FEV1 AUC 0-6

  Day 1

• Percent Change From Baseline in FEV1 AUC

  Day 8

Study Arms (2)

Placebo MDPI

PLACEBO COMPARATOR

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

Drug: Placebo MDPI

Albuterol MDPI

EXPERIMENTAL

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.

Drug: Albuterol MDPI

Interventions

Placebo MDPI DRUG

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.

Also known as: Placebo Spiromax®

Placebo MDPI

Albuterol MDPI DRUG

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.

Also known as: ProAir® RespiClick, Albuterol Spiromax®

Albuterol MDPI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (38)

Teva Investigational Site 10077

Birmingham, Alabama, United States

Location

Teva Investigational Site 10079

Phoenix, Arizona, United States

Location

Teva Investigational Site 10569

Costa Mesa, California, United States

Location

Teva Investigational Site 10053

Fountain Valley, California, United States

Location

Teva Investigational Site 10065

Huntington Beach, California, United States

Location

Teva Investigational Site 10572

Huntington Beach, California, United States

Location

Teva Investigational Site 10075

Los Angeles, California, United States

Location

Teva Investigational Site 10061

Roseville, California, United States

Location

Teva Investigational Site 10066

San Diego, California, United States

Location

Teva Investigational Site 10068

Denver, Colorado, United States

Location

Teva Investigational Site 10069

Denver, Colorado, United States

Location

Teva Investigational Site 10058

Miami, Florida, United States

Location

Teva Investigational Site 10060

Miami, Florida, United States

Location

Teva Investigational Site 10064

Ormond Beach, Florida, United States

Location

Teva Investigational Site 10071

Savannah, Georgia, United States

Location

Teva Investigational Site 10073

Wichita, Kansas, United States

Location

Teva Investigational Site 10070

Owensboro, Kentucky, United States

Location

Teva Investigational Site 10063

Bethesda, Maryland, United States

Location

Teva Investigational Site 10571

Gaithersburg, Maryland, United States

Location

Teva Investigational Site 10067

Wheaton, Maryland, United States

Location

Teva Investigational Site 10072

St Louis, Missouri, United States

Location

Teva Investigational Site 10050

Missoula, Montana, United States

Location

Teva Investigational Site 10057

Raleigh, North Carolina, United States

Location

Teva Investigational Site 10051

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10078

Sylvania, Ohio, United States

Location

Teva Investigational Site 10054

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10568

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10055

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 10056

Medford, Oregon, United States

Location

Teva Investigational Site 10076

Medford, Oregon, United States

Location

Teva Investigational Site 10684

Charleston, South Carolina, United States

Location

Teva Investigational Site 10570

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 10049

Live Oak, Texas, United States

Location

Teva Investigational Site 10052

San Antonio, Texas, United States

Location

Teva Investigational Site 10685

Waco, Texas, United States

Location

Teva Investigational Site 10059

Fairfax, Virginia, United States

Location

Teva Investigational Site 10074

Puyallup, Washington, United States

Location

Teva Investigational Site 10062

Tacoma, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 26369589 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Clinical Project Leader

  Teva Respiratory R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 29, 2011
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 26, 2015
• Results First Posted: May 20, 2015

Record last verified: 2015-05

Locations

US (38)