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

NCT ID: NCT01857323

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-09-30

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.

Detailed Description

The study consists of a screening/run-in period where, after meeting study criteria, patients enter a run-in period lasting 7 to 14 ±2 days, during which diary and medication compliance, as well as inhaler technique, will be assessed. The run-in period will commence the day following the completion of all screening procedures and will continue through to and include the day prior to the first treatment visit (TV1) such that a minimum of 7 full days of diary data will be collected prior to TV1. The purpose of the run-in period is to assess compliance with a BID dosing regimen and with the completion of the diary entries over a minimum period of 7 days. Patients who demonstrate adequate inhaler technique and who are at least 90% compliant with dosing and completion of the diary on the last 7 consecutive days of run-in will qualify for enrollment into the open-label study. The study treatment period will comprise 6 treatment visits (TV1-TV6) for all enrolled patients except those in the 5-week treatment cohort who will have only 5 treatment visits (TV1-TV5). Patients may continue taking their current asthma or COPD medications throughout the Treatment Period. The patient will return to the clinic on Days 8 (±1), 15 (±1), 22 (±1), and 36 (±1), and then on Day 50 (-2) after approximately all 200 doses have been delivered, or until early withdrawal. The patient will be deemed to have completed the study if at least 90% of the recommended doses contained in Albuterol Spiromax with dose-counter were used. A representative sample (approximately 15%) of patients will participate in the trial for approximately 5 weeks with Day 36 (±1) being the final study visit.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albuterol Spiromax®

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.

Group Type: EXPERIMENTAL

Albuterol Spiromax®

Intervention Type: 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.

Interventions

Albuterol Spiromax®

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.

Intervention Type: DRUG

Other Intervention Names

ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)

Eligibility Criteria

Inclusion Criteria

1. Written informed consent/assent signed and dated by the patient and/or parent/legal guardian before conducting any study related procedure

2. 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

3. 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

4. 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

5. Has a physician diagnosis of asthma or COPD with symptoms of bronchoconstriction requiring the use of short-acting β2-agonists

6. Current Therapy: The patient's current asthma/COPD controller treatment regimen has remained stable for at least four weeks prior to the SV

7. 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)

8. Able to demonstrate satisfactory Spiromax inhaler use and technique.

Exclusion Criteria

1. 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

2. 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

3. Is being treated with a long-acting β2-agonist alone

4. 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.

5. 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.

6. Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg or diastolic BP >100 mmHg)

7. 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.

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 10620

Phoenix, Arizona, United States

Teva Investigational Site 10637

Costa Mesa, California, United States

Teva Investigational Site 10635

Huntington Beach, California, United States

Teva Investigational Site 10647

Rolling Hills Estates, California, United States

Teva Investigational Site 10643

San Diego, California, United States

Teva Investigational Site 10644

San Jose, California, United States

Teva Investigational Site 10622

Centennial, Colorado, United States

Teva Investigational Site 10634

Denver, Colorado, United States

Teva Investigational Site 10645

Wheat Ridge, Colorado, United States

Teva Investigational Site 10633

Miami, Florida, United States

Teva Investigational Site 10640

Ormond Beach, Florida, United States

Teva Investigational Site 10641

Overland Park, Kansas, United States

Teva Investigational Site 10636

Bethesda, Maryland, United States

Teva Investigational Site 10631

North Dartmouth, Massachusetts, United States

Teva Investigational Site 10646

Plymouth, Minnesota, United States

Teva Investigational Site 10627

St Louis, Missouri, United States

Teva Investigational Site 10642

Bozeman, Montana, United States

Teva Investigational Site 10613

High Point, North Carolina, United States

Teva Investigational Site 10616

Raleigh, North Carolina, United States

Teva Investigational Site 10618

Canton, Ohio, United States

Teva Investigational Site 10615

Oklahoma City, Oklahoma, United States

Teva Investigational Site 10624

Tulsa, Oklahoma, United States

Teva Investigational Site 10625

Eugene, Oregon, United States

Teva Investigational Site 10626

Medford, Oregon, United States

Teva Investigational Site 10632

Portland, Oregon, United States

Teva Investigational Site 10639

Charleston, South Carolina, United States

Teva Investigational Site 10617

Spartanburg, South Carolina, United States

Teva Investigational Site 10630

Dallas, Texas, United States

Teva Investigational Site 10623

New Braunfels, Texas, United States

Teva Investigational Site 10638

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26831652 (View on PubMed)

Other Identifiers

ABS-AS-308

Identifier Type: -

Identifier Source: org_study_id