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

NCT01747629 | Completed Phase 3 Results

• 1 other identifier: ABS-AS-304
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 35

Brief Summary

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

Conditions

Asthma

Keywords

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

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) over six hours of the 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 (13)

• 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 93

• Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group

  Day 1 (Baseline), Day 85

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (35)

Teva Investigational Site 10225

Costa Mesa, California, United States

Location

Teva Investigational Site 10250

Encinitas, California, United States

Location

Teva Investigational Site 10230

Huntington Beach, California, United States

Location

Teva Investigational Site 10255

Palmdale, California, United States

Location

Teva Investigational Site 10231

Rancho Mirage, California, United States

Location

Teva Investigational Site 10252

Riverside, California, United States

Location

Teva Investigational Site 10242

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 10238

San Diego, California, United States

Location

Teva Investigational Site 10243

San Jose, California, United States

Location

Teva Investigational Site 10247

Miami Lakes, Florida, United States

Location

Teva Investigational Site 10239

Tallahassee, Florida, United States

Location

Teva Investigational Site 10234

Tampa, Florida, United States

Location

Teva Investigational Site 10253

Bangor, Maine, United States

Location

Teva Investigational Site 10257

Baltimore, Maryland, United States

Location

Teva Investigational Site 10254

White Marsh, Maryland, United States

Location

Teva Investigational Site 10235

Fall River, Massachusetts, United States

Location

Teva Investigational Site 10236

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10226

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 10233

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 10241

St Louis, Missouri, United States

Location

Teva Investigational Site 10229

Bellevue, Nebraska, United States

Location

Teva Investigational Site 10227

Rochester, New York, United States

Location

Teva Investigational Site 10244

Charlotte, North Carolina, United States

Location

Teva Investigational Site 10248

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10249

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10232

Eugene, Oregon, United States

Location

Teva Investigational Site 10259

Medford, Oregon, United States

Location

Teva Investigational Site 10237

Portland, Oregon, United States

Location

Teva Investigational Site 10240

Bethlehem, Pennsylvania, United States

Location

Teva Investigational Site 10246

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 10256

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 10251

Rock Hill, South Carolina, United States

Location

Teva Investigational Site 10228

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 10258

San Antonio, Texas, United States

Location

Teva Investigational Site 10245

Seattle, 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

1-215-591-3000

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: December 7, 2012
• First Posted: December 11, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 26, 2015
• Results First Posted: May 21, 2015

Record last verified: 2015-05

Locations

US (35)