4 years ago

Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma

Therapeutic equivalence of Budesonide/formoterol Easyhaler compared to Symbicort Turbuhaler has been previously demonstrated with in vitro and pharmacokinetic studies. This study was performed to confirm equivalent bronchodilator efficacy of the products in asthmatic patients. Methods A randomised, single-dose, 4-period crossover study was carried out in a double-blind, double-dummy manner in 11 study sites. The studied doses were 320/9 μg and 1280/36 μg of budesonide/formoterol delivered by Easyhaler and Turbuhaler. Spirometry was performed before and 10 min, 20 min and 1, 2, 3, 4, 6, 8, 10 and 12 h after administration of the study treatments. The primary efficacy endpoint was average 12-h forced expiratory volume in 1 s (FEV1). The secondary efficacy endpoints were maximum FEV1 and FEV1 at 12 h post-dose. Results 72 asthma patients with reversible airway obstruction were randomised to receive study treatments. 53 patients completed all study periods according to the protocol and had sufficient data available to calculate the primary endpoint. They were included in the per-protocol analyses. The assay sensitivity of the study was shown as the common slope of average 12-h FEV1 between doses was 0.063 (95% CI 0.032–0.093) and showed statistical significance (p < 0.001). In equivalence testing, the difference in average 12-h FEV1 between the treatments (Easyhaler-Turbuhaler) was 0.013 l at the lower dose and −0.028 l at the higher dose, and 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. The results of the secondary efficacy endpoints were in line with the results of the primary endpoint. All treatments were well tolerated. Conclusions The results confirm equivalent bronchodilator efficacy of Budesonide/formoterol Easyhaler compared to Symbicort Turbuhaler. Trial registration This trial was registered on ClinicalTrials.gov, Identifier: NCT02308098.

Publisher URL: www.sciencedirect.com/science

DOI: S0954611116302463

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.