NCT02062463

Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma

A 12-Week, Randomized, Open-Label, Parallel-Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as Compared With SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients With Asthma (The Easy Low Instruction Over Time [ELIOT] Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX	SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg)
DRUG	SYMBICORT TURBOHALER budesonide and formoterol fumarate	SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)

Timeline

• Start date: 2014-05-28
• Primary completion: 2015-03-13
• Completion: 2015-03-13
• First posted: 2014-02-13
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

74 sites across 1 country: United Kingdom