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

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.

Timeline

Start

2014-05-28

Primary completion

2015-03-13

Completion

2015-03-13

Outcome

Mixed primary results

registry Stage 1: Empty Spiromax vs Stage 1: Empty Turbohaler; p <0.001; Odds Ratio (OR) 3.77 (95% CI 2.05 to 6.95) NCT02062463 ↗

registry Stage 2: BF Spiromax vs Stage 2: Symbicort Turbohaler; p = 0.316; Odds Ratio (OR) 1.26 (95% CI 0.80 to 1.98) NCT02062463 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	160 ug	Inhaled
Subject	Budesonide	Small molecule	200 ug	Inhaled
Subject	Budesonide	Small molecule	320 ug	Inhaled
Subject	Budesonide	Small molecule	400 ug	Inhaled
Subject	Formoterol	Other / unclassified	4.5 ug	Inhaled
Subject	Formoterol	Other / unclassified	6 ug	Inhaled
Subject	Formoterol	Other / unclassified	9 ug	Inhaled
Subject	Formoterol	Other / unclassified	12 ug	Inhaled

Indications