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SPIOLTO® Respimat®

SPIOLTO® Respimat® is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).1

Mechanism of action

SPIOLTO® Respimat® is a fixed dose combination inhalation solution containing the long-acting muscarinic receptor antagonist (LAMA), tiotropium and the long-acting beta2-agonist (LABA), olodaterol which is delivered via the SPIOLTO® Respimat® soft mist inhaler device.1

The two active ingredients provide additive bronchodilation due to their different modes of action.1 Since muscarinic receptors appear to be more prominent in the central airways while beta2-adrenoceptors have a higher expression level in the peripheral airways, a combination of tiotropium and olodaterol should provide optimal bronchodilatation in all regions of the lungs.1

Tiotropium - Tiotropium bromide is a long-acting, specific antagonist at muscarinic receptors.1

Olodaterol - Olodaterol has a high affinity and high selectivity to the human beta2-adrenoceptor.1

Efficacy

In two replicate, 12-week, randomised, double-blind, parallel-group, placebo-controlled trials of tiotropium/olodaterol Respimat® 5/5 μg and 2.5/5 μg, tiotropium Respimat® 5 μg and placebo, three co-primary endpoints were evaluated: SGRQ score, FEV1 AUC0–3h and trough FEV1 response.2 The following secondary endpoints were also evaluated: TDI focal score, FVC AUC0–3h and trough FVC.2

Below, we have only discussed tiotropium/olodaterol Respimat® 5/5 μg (SPIOLTO® Respimat®) compared with tiotropium Respimat® 5 μg (SPIRIVA® Respimat®).

AUC0–3h, area under the curve 0–3 hours; FEV1, forced expiratory volume in one second; FVC, forced vital capacity; SGRQ, St George's Respiratory Questionnaire; TDI, transition dyspnoea index.

SPIOLTO® Respimat® improves breathlessness vs SPIRIVA® Respimat®2,3

SPIOLTO® Respimat® statistically significantly improves breathlessness in patients vs SPIRIVA® Respimat®.2,3

Difference of 0.59 units was below the MCID of 1 unit2

Data presented were at 12 weeks.

As measured by TDI focal score at 12 weeks of treatment. An increase in TDI score indicates an improvement in breathlessness. A 1-unit change in the TDI focal score is considered clinically important.

MCID, minimal clinically important difference; TDI, transition dyspnoea index.

SPIOLTO® Respimat® improves health-related quality of life vs SPIRIVA® Respimat®3

SPIOLTO® Respimat® shows statistically significant improvements in health-related quality of life over SPIRIVA® Respimat®.3

SPIOLTO® Respimat® improves lung function vs SPIRIVA® Respimat®4

SPIOLTO® Respimat® provides a statistically significant improvement in lung function vs SPIRIVA® Respimat®.4

Data presented were at 12 weeks.

AUC0–3h, area under the curve 0–3 hours; FEV1, forced expiratory volume in one second.

SPIOLTO® Respimat® improves exercise endurance time vs placebo5

In a 12-week, randomised, partially double-blind, placebo-controlled, parallel-group trial in patients participating in a SMBM program, the effect of SPIOLTO® Respimat® on exercise endurance time (with or without ExT) was evaluated.5

At 8 weeks, there was a 46% improvement in exercise endurance time with SPIOLTO® Respimat® + SMBM and ExT vs placebo + SMBM (p=0.0002). SPIOLTO® Respimat® + SMBM also demonstrated a 29% improvement in exercise endurance time vs placebo + SMBM at 8 weeks (P=0.0109).5

ExT, exercise training; SMBM, self-management behaviour-modification program.

SPIOLTO® Respimat®: annualised rate of moderate to severe COPD exacerbations compared to SPIRIVA® Respimat® over 52 weeks6

DYNAGITO® was a one-year exacerbation trial with 7,880 patients.6 The primary endpoint of the study was designed to assess the annualised rate of moderate to severe COPD exacerbations over 52 weeks, with SPIOLTO® Respimat® vs SPIRIVA® Respimat® with a significance level of 1% (p ≤0.01). This was not met.6

SPIOLTO® Respimat® (tiotropium and olodaterol) is not licensed for the treatment of exacerbations.1

CI, confidence interval; RR, relative risk.

Safety profile

SPIOLTO® Respimat® was generally well-tolerated with an adverse event profile similar to the profiles of the monotherapies.1,7−10

Most adverse events were mild or moderate with no new safety risks seen beyond the known effects of the ingredients.1,7−10

The proportion of patients who discontinued SPIOLTO® Respimat® due to an adverse event was comparable to SPIRIVA® Respimat® or ▼STRIVERDI® Respimat® (olodaterol).7

Serious undesirable effects include anaphylactic reaction and consistent with anticholinergic effects: glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention.1

For full safety information, please refer to the SPIOLTO® Respimat® Summary of Product Characteristics.

Method of administration

The recommended dose is two puffs from the SPIOlTO® Respimat® inhaler at the same time of the day.1

Prepare for use1
1. Remove clear base
  • Keep the cap closed.
  • Press the safety catch while pulling off the clear base with the other hand.

2. Insert cartridge
  • Insert the cartridge into the inhaler.
  • Place the inhaler on a firm surface and push down firmly until it clicks into place.

3. Track cartridge
  • Mark the check-box on inhaler’s label to track the number of cartridges.
  • Put the clear base back into place until it clicks.

4. Turn
  • Keep the cap closed.
  • Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).

5. Open
  • Open the cap until it snaps fully open.

6. Press
  • Point the inhaler towards the ground.
  • Press the dose-release button.
  • Close the cap.
  • Repeat steps 4-6 until a cloud is visible.
  • After a cloud is visible, repeat steps 4-6 three more times.

The inhaler is now ready to use and will deliver 60 puffs (30 doses).

Daily use1
TURN
  • Keep the cap closed.
  • TURN the clear base in the direction of the arrows on the label until it clicks (half a turn).

OPEN
  • OPEN the cap until it snaps fully open.

PRESS
  • Breathe out slowly and fully.
  • Close the lips around the mouthpiece without covering the air vents. Point the inhaler to the back of the throat.
  • While taking a slow, deep breath through the mouth, PRESS the dose-release button and continue to breathe in slowly for as long as comfortable.
  • Hold the breath for 10 seconds or for as long as comfortable.
  • Repeat TURN, OPEN, PRESS for a total of 2 puffs.
  • Close the cap until the inhaler is used again.

When to replace the SPIOLTO® Respimat® cartridge1

Each cartridge of SPIOLTO® Respimat® contains 60 puffs (30 doses) if used as indicated (TWO PUFFS, ONCE DAILY).1

The dose indicator shows how many puffs remain in the cartridge.1

Once the cartridge is finished, turn the clear base to loosen it, and remove the clear base.1 Pull the cartridge out of the inhaler and insert a new one as shown under ‘Prepare for use’.

When to replace the inhaler

When the patient has used the inhaler with six cartridges, get a new SPIOLTO® Respimat® pack containing an inhaler and cartridge.1

References

  1. SPIOLTO® Respimat® Summary of Product Characteristics.
  2. Singh D et al. Respir Res. 2015;109(10):1312–9.
  3. Singh D et al. Respir Res. 2015;109(10):1312–9. Supplementary data.
  4. Singh D et al. European Respiratory Society International Congress, Amsterdam, The Netherlands, 26–30 September 2015; PA2958.
  5. Troosters T et al. Am J Respir Crit Care Med. 2018;198(8):1021–32 and supplementary material.
  6. Calverley P et al. Lancet Respir Med. 2018;6:337–44.
  7. Buhl R et al. Eur Resp J 2015;45:969–79.
  8. SPIRIVA® Respimat® Summary of Product Characteristics.
  9. SPIRIVA® Summary of Product Characteristics.
  10. STRIVERDI® Respimat® Summary of Product Characteristics.

PC-GB-101639 V3 November 2020