To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

Summary

The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.

Timeline

Start

2014-12

Primary completion

2015-06

Completion

2015-06

Outcome

Met primary endpoint

paper their 95% confidence intervals (CIs) (-0.047 to 0.073 and -0.087 to 0.032, respectively) fell within the range of a clinically non-relevant difference. PMID 27817813 ↗

paper The results confirm equivalent bronchodilator efficacy of Budesonide/formoterol Easyhaler compared to Symbicort Turbuhaler. PMID 27817813 ↗

Publications

• Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide/formoterol	Unknown	320 ug	Inhaled
Subject	Budesonide/formoterol	Unknown	1280 ug	Inhaled

Indications