Aug 17 2015
Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD[1]. These data are published online in the journal Respiratory Medicine.
For COPD patients, breathlessness, among other symptoms, limits their ability to keep active and has a negative impact on their daily lives. As there is no cure for COPD, improving quality of life is a major goal of treatment. In COPD, quality of life is measured using the SGRQ[2]; a reduction in SGRQ score of 4 points or more is deemed clinically meaningful.[ii] The OTEMTO® trials show Spiolto® Respimat® provides a reduction in SGRQ total score of 4.67[3] versus placebo.
Dave Singh, Professor of clinical pharmacology and respiratory medicine, University of Manchester and lead investigator of the OTEMTO® trials, said:
The improvement in quality of life provided by Spiolto® Respimat® in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life”
“For example, this could mean that patients are able to walk up stairs without stopping, go out to socialise with friends or find it easier to wash and dress. Essentially, the data show that patients feel much better.”
Further data from the 1,600 patient OTEMTO® trials show Spiolto® Respimat® provides:
- Clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal score[4]), reflecting the meaningful quality of life benefits.
- Consistent improvements in lung function, breathlessness and quality of life compared to Spiriva® (tiotropium).
- A safety profile similar to Spiriva® or placebo. Incidence of adverse events (AEs) was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups.
OTEMTO® 1&2 build on the pivotal phase III TONADO® trials that demonstrated Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and reduction in rescue medication use over Spiriva® Respimat® right from the initial disease stages when patients first need maintenance therapy. [iii],[iv] OTEMTO® 1&2 are part of the >15,000 patient TOviTO® Phase III clinical trial programme, one of the largest trial programmes conducted in COPD.
U.S. Food and Drug Administration (FDA) recently accepted for review a Supplemental New Drug Application (sNDA) to include the OTEMTO® quality of life data in the Stiolto™ Respimat®[5] label.
References
[1] Chronic obstructive pulmonary disease
[2] St George’s Respiratory Questionnaire (SGRQ), a disease-specific patient-reported instrument that evaluates symptoms including frequency and duration of cough, wheezing and breathlessness
[3] SGRQ total score after 12 weeks of treatment in the combined data set of the 2 replicate studies OTEMTO®1 and OTEMTO® 2
[4] Transition dyspnoea index focal score after 12 weeks of treatment in the combined data set
[5] Spiolto® Respimat® is marketed as Stiolto™ Respimat® in the US and Inspiolto™ Respimat® in Canada
[6] Marketed as Striverdi® Respimat®
[7] Respimat® delivers a metered dose of medication in a mist at the push of a button not requiring the force from the patient’s inhalation
[8] patients with GOLD 2 COPD
[i] Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium+olodaterol shows clinically meaningful improvements in quality of life. Res Med 2015 DOI: http://dx.doi.org/10.1016/j.rmed.2015.08.002
[ii] Jones PW. St George’s Respiratory Questionnaire: MCID. COPD 2005; 2(1):75-9.
[iii] Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015; 45(4):969-79.
[iv] Ferguson GT, Flezar M, Korn S, et al. Efficacy of tiotropium + olodaterol in patients with COPD by initial disease severity and treatment intensity. Adv Ther 2015; 32(6): 523–36.
[v] BI data on file.
[vi] Ferguson GT, Feldman GJ, Hofbauer P, et al. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014;9:629-45.
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[xviii] Mapel DW, Dalal AA, Blanchette CM, et al. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J COPD 2011; 6 573–81.
[xix] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD. 2015. Available from: http://www.goldcopd.org/ [Last accessed Aug 2015]
[xx] Tantucci C, Modina D. Lung function decline in COPD. Int J COPD. 2012; 7:95–9.