Expanded indication for Spiriva® (tiotropium) Respimat®: now licensed for people with asthma from 6 years and older1
- Tiotropium Respimat® is now indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year1
- The new UK indication follows EU approval in March 2018, supported by evidence from the large scale UniTinA-asthma® clinical trial programme
- The regulatory acceptance reflects the benefit tiotropium Respimat® add-on maintenance therapy can bring compared with standard maintenance therapy, to patients as young as 6 years old1-5
- Tiotropium Respimat® was previously indicated in asthma as add-on maintenance therapy in adult patients.
Bracknell, United Kingdom, 7 June 2018 – Boehringer Ingelheim today announced an expanded UK indication for Spiriva® (tiotropium) Respimat® as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the past year,1 following the EU regulatory acceptance in March 2018.
“Asthma is one of the most common long-term illnesses in childhood and yet there are relatively few treatments which have been proven to be of benefit in young patients,” commented Professor David Halpin, Consultant Physician at the Royal Devon and Exeter Hospital. “I welcome this expanded indication for Spiriva® Respimat®, which is based upon robust clinical trial evidence, and which recognises the efficacy and safety of tiotropium maintenance therapy in patients as young as 6 years old as well as adults.”
The UK has one of the highest prevalence rates for paediatric asthma worldwide, with 1 in 11 children affected.6 It is estimated that in the UK UK/SPRT-181029, June 2018 Boehringer Ingelheim Press Release page 2 of 3
a child is admitted to hospital every 20 minutes because of an asthma attack.6
Tiotropium Respimat® is part of a class of medicines called long-acting muscarinic antagonists (LAMA) and it works by preventing the air passages closing, to improve the airflow in and out of the lungs.7 The new indication is supported by the completion of the large scale UniTinA-asthma® clinical trial programme. This showed that tiotropium Respimat® improves lung function in patients with asthma as young as 6 years old when added to maintenance therapy, compared to control groups alone.1-5,8 The safety profile of tiotropium Respimat® across all age groups is comparable to placebo.9,10
Tiotropium Respimat® was previously approved as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 μg budesonide/day or equivalent) and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year.
1. Electronic Medicines Compendium, SPC Spiriva Respimat 2.5 microgram, inhalation solution: https://www.medicines.org.uk/emc/medicine/20134 (last accessed: June 2018)
2. Szefler S.J. et al. A phase III randomized controlled trial of tiotropium add-on therapy in children with severe symptomatic asthma. J Allergy Clin Immunol. 2017; 140:1277-87.
3. Hamelmann E, Bernstein JA, Vandewalker M, et al. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma. Eur Respir J 2017; 49: 1601100.
4. Hamelmann E et al. Once-daily tiotropium Respimat add-on therapy improves lung function in patients aged 6-17 years with severe symptomatic asthma. Pediatr Pulmonol 2017;52(S46):S100-S176. Abstract A53.
5. Kerstjens HAM. et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med. 2012;367(13):1198-1207.
6. Asthma UK, ‘Asthma facts and statistics’, available at: https://www.asthma.org.uk/about/media/facts-and-statistics/ (last accessed: June 2018).
7. Tiotropium – a bronchodilator (Braltus, Spiriva), available at: https://patient.info/medicine/tiotropium-a-bronchodilator-braltus-spiriva (last accessed: June 2018).
8. Kerstjens HAM. et al. Tiotropium improves lung function, exacerbation rate, and asthma control, independent of baseline characteristics including age, degree of airway obstruction and allergic status. Lancet Resp Med. 2016;117:198-206.
9. Vogelberg, C. et al. Safety of tiotropium Respimat® add-on therapy in patients aged 6-17 years with symptomatic asthma. Study 205.444 (RubaTinA-asthma®), 205.456 (PensieTinA-asthma®), 205.446 (VivaTinA-asthma®). Poster presented at ERS International Congress 2016.
10. Dahl R. et al. Safety and tolerability of once-daily tiotropium Respimat® as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis. Respir Med. 2016;118:102-111.