Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)

NCT01857323 | Completed Phase 3 Results

• 1 other identifier: ABS-AS-308
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 30

Brief Summary

This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler integrated dose counter in a clinical setting.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

asthma; chronic obstructive pulmonary disease; COPD; Albuterol Spiromax®

Outcome Measures

Primary Outcomes (1)

• Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count

  The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as "number of discrepancies/total number of dose cycles" \*200.

  Day 1 - Day 50

Secondary Outcomes (5)

• Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up

  Day 1 - Day 50

• Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle

  Day 1 - Day 50

• Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle

  Day 1 - Day 50

• Absolute Value of Total Discrepancy Size Per Inhaler

  Day 1 - Day 50

• Participants With Treatment-Emergent Adverse Events

  Day 1 to Day 50

Study Arms (1)

Albuterol Spiromax®

EXPERIMENTAL

The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.

Drug: Albuterol Spiromax®

Interventions

Albuterol Spiromax® DRUG

Albuterol Spiromax delivers 90 mcg of albuterol base from the mouthpiece per triggered dose. Participants took doses of 2 inhalations each twice a day (morning and evening) for a total daily dose of 360 mcg. The first 45 enrolled participants constituted a subgroup who were dosed for 35 days, while most participants were dosed for 50 days.

Also known as: ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)

Albuterol Spiromax®

Eligibility Criteria

• Age: 4 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 signed and dated by the patient and/or parent/legal guardian before conducting any study related procedure
• Male or female (non pregnant/non lactating) patients 4 years of age or older at the time of the screening visit (SV) who are able to understand English
• Females of childbearing potential (as judged by the investigator) currently using and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Females who are not sexually active must agree to use a medically reliable method of contraception should they become active during the course of the study. Women of childbearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the SV. Female patients will be considered to be of non-child-bearing potential and will not require a urine pregnancy test if at least one of the following apply:a. before menarche; b. more than one year post-menopausal; c. had a hysterectomy, bilateral oophorectomy, salpingectomy, or tubal ligation; d. has congenital sterility
• General good health, defined as free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study
• Has a physician diagnosis of asthma or COPD with symptoms of bronchoconstriction requiring the use of short-acting β2-agonists
• Current Therapy: The patient's current asthma/COPD controller treatment regimen has remained stable for at least four weeks prior to the SV
• Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record keeping, etc)
• Able to demonstrate satisfactory Spiromax inhaler use and technique.

You may not qualify if:

• History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures
• Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the SV; or that occurs between the SV and TV1
• Is being treated with a long-acting β2-agonist alone
• Any asthma exacerbation requiring oral corticosteroids within 2 months of SV and any COPD exacerbation requiring oral corticosteroids within 1 month of the SV. A patient must not have been hospitalized for asthma or COPD within 4 months prior to the SV.
• Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease, cerebrovascular accident), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), and/or gastrointestinal (e.g., poorly-controlled peptic ulcer or gastroesophageal reflux disease \[GERD\]). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study.
• Uncontrolled hypertension (systolic blood pressure \[BP\] ≥160 mmHg or diastolic BP \>100 mmHg)
• History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or any component of the Albuterol Spiromax DPI or rescue ProAir Hydrofluoroalkane (HFA) Metered-dose inhaler (MDI) formulation.

Sponsors & Collaborators

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

Study Sites (30)

Teva Investigational Site 10620

Phoenix, Arizona, United States

Location

Teva Investigational Site 10637

Costa Mesa, California, United States

Location

Teva Investigational Site 10635

Huntington Beach, California, United States

Location

Teva Investigational Site 10647

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 10643

San Diego, California, United States

Location

Teva Investigational Site 10644

San Jose, California, United States

Location

Teva Investigational Site 10622

Centennial, Colorado, United States

Location

Teva Investigational Site 10634

Denver, Colorado, United States

Location

Teva Investigational Site 10645

Wheat Ridge, Colorado, United States

Location

Teva Investigational Site 10633

Miami, Florida, United States

Location

Teva Investigational Site 10640

Ormond Beach, Florida, United States

Location

Teva Investigational Site 10641

Overland Park, Kansas, United States

Location

Teva Investigational Site 10636

Bethesda, Maryland, United States

Location

Teva Investigational Site 10631

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10646

Plymouth, Minnesota, United States

Location

Teva Investigational Site 10627

St Louis, Missouri, United States

Location

Teva Investigational Site 10642

Bozeman, Montana, United States

Location

Teva Investigational Site 10613

High Point, North Carolina, United States

Location

Teva Investigational Site 10616

Raleigh, North Carolina, United States

Location

Teva Investigational Site 10618

Canton, Ohio, United States

Location

Teva Investigational Site 10615

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10624

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 10625

Eugene, Oregon, United States

Location

Teva Investigational Site 10626

Medford, Oregon, United States

Location

Teva Investigational Site 10632

Portland, Oregon, United States

Location

Teva Investigational Site 10639

Charleston, South Carolina, United States

Location

Teva Investigational Site 10617

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 10630

Dallas, Texas, United States

Location

Teva Investigational Site 10623

New Braunfels, Texas, United States

Location

Teva Investigational Site 10638

San Antonio, Texas, United States

Location

Related Publications (1)

• Given J, Taveras H, Iverson H. Prospective, open-label evaluation of a new albuterol multidose dry powder inhaler with integrated dose counter. Allergy Asthma Proc. 2016 May;37(3):199-206. doi: 10.2500/aap.2016.37.3938. Epub 2016 Jan 29.

  PMID: 26831652 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

ustevatrials@tevapharm.com

1-215-591-3000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-05

Locations

US (30)