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For Healthcare Professionals

SPIRIVA® RESPIMAT®

For Asthma

Efficacy

Adult patients with severe asthma

In two replicate, 48-week, randomized, double-blind, placebo-controlled, parallel-group clinical trials of SPIRIVA® RESPIMAT®, PrimoTinA-asthma, two co-primary lung function endpoints were evaluated at week 24: peak FEV1 response and trough FEV1 response.1 A third co-primary exacerbation endpoint was also evaluated: time to first severe exacerbation (pooled data from trials 1 and 2 over 48 weeks).1

SPIRIVA® RESPIMAT® significantly improved lung function vs control* in adults1

SPIRIVA® RESPIMAT® significantly improved lung function vs control* in adult patients with severe, symptomatic asthma who had a post-bronchodilator FEV1 of ≤80% of the predicted value, and a history of ≥1 severe exacerbation in the previous year.1

In Trial 1, the mean improvement in peak FEV1 between SPIRIVA® RESPIMAT® and control was 86 mL at week 24 (95% CI 20−152; p<0.05).2

trail2_0_Asthma_0

The mean improvement in trough FEV1 between SPIRIVA® RESPIMAT® and control at week 24 was 88 mL (p=0.01) in Trial 1 and 111 mL (p<0.001) in Trial 2.1

SPIRIVA® RESPIMAT® significantly reduced the relative risk of first severe asthma exacerbation vs control* in adults1

SPIRIVA® RESPIMAT® significantly reduced the relative risk of first severe asthma exacerbation vs control* in adult patients with severe, symptomatic asthma who had a post-bronchodilator FEV1 of ≤80% of the predicted value, and a history of ≥1 severe exacerbation in the previous year (HR 0.79; 95% CI 0.62–1.00; p=0.03).1

Time to the first severe asthma exacerbation was a prespecified co-primary endpoint. This was a 48-week pooled analysis.1

exacerbation_0_0

Adult patients with moderate asthma

In two replicate, 24-week, randomized, double-blind, placebo-controlled, parallel-group clinical trials of SPIRIVA® RESPIMAT®, MezzoTinA-asthma, two co-primary lung function endpoints were evaluated at week 24: peak FEV1 response and trough FEV1 response. A third co-primary exacerbation endpoint was also evaluated: responder rate assessed by an improvement in ACQ-7 score of 0.5 or more at the end of week 24. Patients with moderate symptomatic asthma and a pre-bronchodilator FEV1 of 60–90% predicted despite use of medium-dose inhaled corticosteroids, and had never smoked or were ex-smokers for 1 year or more with 10 pack-years or less were randomly assigned (1:1:1:1) to receive once-daily tiotropium 5 μg or 2·5 μg, twice-daily salmeterol 50 μg, or placebo, while maintaining inhaled corticosteroids.2

SPIRIVA® RESPIMAT® is a safe and effective alternative bronchodilator to salmeterol in adult patients with moderate asthma2

Peak and trough FEV1 responses were significantly greater with tiotropium and salmeterol than with placebo. With pooled data, difference versus placebo in peak FEV1 was 185 mL (95% CI 146–223) in the SPIRIVA® 5 μg group, 223 mL (185–262) in the SPIRIVA® 2·5 μg group, and 196 mL (158–234) in the salmeterol group (all p<0·0001); difference in trough FEV1 was 146 mL (95% CI 105–188), 180 mL (138–221), and 114 mL (73–155; all p<0·0001), respectively.

Efficacy_figure_3_renew

There were more ACQ-7 responders in the SPIRIVA® 5 μg (OR 1·32, 95% CI 1·02–1·71; p=0·035) and 2·5 μg (1·33, 1·03–1·72; p=0·031) groups, and the salmeterol group (1·46, 1·13–1·89; p=0·0039), than in the placebo group. The occurrence of serious adverse events was similar with 11 patients in SPIRIVA® 5 μg group, 12 patients in SPIRIVA® 2.5 μg group, 11 patients in salmeterol group and 14 patients in placebo group.

Pediatric patients

SPIRIVA® RESPIMAT® significantly improved lung function vs control† in children (6−11 years) with severe asthma3

In a 12-week, Phase III, randomized, double-blind, placebo-controlled, parallel study in children aged 6−11 years with severe symptomatic asthma (n=401) SPIRIVA® RESPIMAT® (5 μg) statistically significantly improved lung function vs control.†‡3

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Changes in lung function with SPIRIVA® RESPIMAT® vs control§ in adolescents (12−17 years) with severe asthma4

In a 12-week Phase III, randomized, double-blind, placebo-controlled, parallel study in adolescents aged 12−17 years with severe symptomatic asthma, SPIRIVA® RESPIMAT® showed numerical improvements in lung function over placebo when used as add-on to background treatment, however, the differences in peak and trough FEV1 were not statistically significant.4

Adding SPIRIVA® RESPIMAT® vs escalating ICS/LABA: a real-world study showed the impact5¶

study_0_0

The secondary outcomes included rate of exacerbations and healthcare resource measures.

  • Rate of exacerbations was found by calculating the proportion of patients with at least one exacerbation within 1 year after the index date

Results from real-world studies are not intended for comparison with clinical trials. Real-world studies were observational trials. Differences in study designs, patient populations, outcome definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information.

Footnotes:

  • *Placebo RESPIMAT®. In both the SPIRIVA® RESPIMAT® and control groups, ICS and LABA maintenance therapy was continued. Other asthma medications were also allowed if the doses remained stable for at least 4 weeks before study entry and for the duration of the trial.1
  • †Placebo RESPIMAT®. In both the SPIRIVA® RESPIMAT® and control groups, patients also received ICS plus at least one other controller medication (e.g. LABA or LTRA).3
  • ‡Patients in experimental arm of this study received either tiotropium 5 μg (2 puffs of 2.5 μg) or 2.5 μg (2 puffs of 1.25 μg), delivered by RESPIMAT®. The tiotropium RESPIMAT® 2.5 μg dose is unlicensed, so we have only discussed tiotropium RESPIMAT® 5 μg (SPIRIVA® RESPIMAT®) vs control.3
  • §Placebo RESPIMAT®. In both the SPIRIVA® RESPIMAT® and control groups, patients also received ICS plus one or more controller therapies.4
  • Real World Evidence:  In this retrospective cohort study, patients with asthma taking ICS/LABA therapy that added SPIRIVA® RESPIMAT® 1.25 mcg were compared to those that increased their ICS/LABA dose. This study extracted data from two retrospective data sources, IMS Pharmetrics and EMRClaims+. It included 123,359 eligible non-SPIRIVA® RESPIMAT® patients and 2,619 patients on SPIRIVA® RESPIMAT® who were matched with 5,238 non-SPIRIVA® RESPIMAT® patients using propensity score matching. Data was extracted from January 2014-December 2018 with the first patient follow-up period for SPIRIVA® RESPIMAT® 1.25 mcg dose patients starting in January 2016. Study compared patients who used SPIRIVA® RESPIMAT® 1.25 mcg in addition to baseline ICS/LABA dose to those who escalated their treatment, either from low-dose ICS/LABA to medium-dose or from medium-dose to high-dose or persistent use of high-dose ICS/LABA. The day their treatment changed was defined as the index date. The primary outcome was risk of exacerbation after the index date and was analyzed using a COX Proportional Hazards model that considers both occurrence of and time-to-occurrence of the first event. Exacerbations were defined as either a hospitalization or an ED visit with primary diagnosis of asthma. The secondary outcomes included rate of exacerbations and healthcare resource measures such as asthma-related hospitalizations and asthma-related ED visits. Rate of exacerbations was found by calculating the proportion of patients with at least one exacerbation within 6 months and 1 year after the index date. Healthcare resource measures were analyzed by calculating the rate (per 100 person-years) of all-cause and asthma related hospitalizations, or ED visits, or outpatient visits within 6 months to 1 year after the index date. Secondary outcomes required follow-ups within 1 year of the index date, limiting the amount of data available to calculate those endpoints.
  • ACQ-7, Asthma Control Questionnaire; ARR, absolute risk reduction; CI, confidence interval; FEV1, forced expiratory volume in one second; HR = hazard ratio; ICS, inhaled corticosteroids; LABA, long-acting β2-agonist. LTRA, leukotriene receptor antagonist; SE, standard error.

References

  1. Kerstjens HAM et al. N Engl J Med. 2012;367(13):1198−207 and supplementary material.

  2. Kerstjens HAM, Casale TB, Bleecker ER, et al. Lancet Respir Med. 2015;3(5):367-376.

  3. Szefler SJ et al. J Allergy Clin lmmunol. 2017;140(5):1277−87

  4. Hamelmann E et al. Eur Respir J. 2017;49:1601100.

  5. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

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