NCT01857323

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

A Prospective, Open-Label Assessment of the Albuterol Spiromax® DPI Integrated Dose Counter

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2013-05-20
• Last updated: 2015-06-08
• Results posted: 2015-06-08

Locations

30 sites across 1 country: United States