Safety & Tolerability

Safety & Tolerability

flutiform showed a similar tolerability profile to Seretide® Evohaler® in a 12-week open label study in patients of 18 years and over using 50/5μg and 125/5μg only.1

flutiform showed a similar tolerability profile to its components administered via separate inhalers in two additional studies (50/5μg and 125/5μg in a 12-week open label study2 and 250/10μg in an 8-week double-blind study).3

  • The majority of adverse events in both studies were mild or moderate in severity.
  • Most commonly reported adverse events were dysphonia, bronchitis, nasopharyngitis, headache, pharyngitis, asthma and viral infection.

Published studies have demonstrated that the absolute oral systemic bioavailability of fluticasone propionate is negligible.4

Exacerbation rate

flutiform has a low severe exacerbation rate of 2.9%, based on pooled incidence data from 2 open-label studies (6–12 months; 50/5μg or 125/5μg two inhalations twice-daily; patients aged >12 years). Severe exacerbations were defined as those requiring oral, intramuscular or intravenous steroids for any respiratory illness.5

References

  1. Bodzenta-Lukaszyk A, Dymek A, et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med 2011:11:28.
  2. Bodzenta-Lukaszyk A, van Noord, et al. Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial. Curr Med Res Opin 2013;29:579-88.
  3. Bodzenta-Lukaszyk A, Pulka G, et al. Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. Respir Med.2011 May;105(5):674-82.
  4. Napp Pharmaceuticals Limited. flutiform® summary of product characteristics. (Last updated: August 2015). http://www.medicines.org.uk/emc/medicine/26954 [Accessed February 2018].
  5. Papi A, Mansur AH, Pertseva T, et al. Long-term Fluticasone propionate/formoterol fumarate combination therapy is associated with a low incidence of severe asthma exacerbations. J Aerosol Med Pulm Drug Deliv 2016 Aug 1;29(4):346-361 .