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    View Flutiform® prescribing information

    Asthma management in children

     

    Asthma is the most common chronic disease in children, imposing a consistent burden on the health system. In recent years, prevalence of asthma symptoms became globally increased in children and adolescents, particularly in low-middle income countries (LMICs).1

    Despite novel treatments and improved inhalers for the administration of inhaled therapies, no further improvements in either mortality or hospitalisation rates have been observed in the last decade, neither in children or in adults.2

    Download paediatric patient leaflet here

    Explore the benefits of flutiform® pMDI for children with asthma

     

    Fast-acting LABA

    1

    flutiform® pMDI 50/5 μg improves lung function and asthma control compared to baseline, with comparable efficacy to fluticasone propionate/ salmeterol pMDI§ and demonstrated a similar safety and tolerability profile vs fluticasone propionate/ salmeterol pMDI in children aged 5 to 12 years.5

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    Vorteile von flutiform® für Kinder mit Asthma
    Inhaler

    2

    flutiform® pMDI 50/5 μg has demonstrated superiority to fluticasone propionate pMDI† and non-inferiority to fluticasone propionate/ salmeterol pMDI‡ for change in pre-dose FEV₁ to 2 hours post-dose over 12 weeks.4

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    Inhaler

    5

    flutiform® pMDI 50/5 μg can be used with a spacer in patients who find it difficult to synchronise actuation and inspiration3

    • GINA 2021 mentions that using pMDIs with spacers improves delivery and reduces the potential for side effects caused by ICS.6
    • Learn how to use flutiform® pMDI via the instruction video and step-by-step guide.
    View for more info
    Growth

    4

    flutiform® pMDI 50/5 μg has not shown effects on plasma cortisol or children's growth5

    • No hypothalamic-pituitary-adrenal axis suppression was observed in a 24-week study with asthmatic children. Mean and median plasma cortisol values remained stable throughout.5
    • Children’s mean height increased by 2.8 cm during the extension phase of the study.5
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    Fast-acting LABA

    3

    Fast-acting LABA3†

    • Onset of bronchodilation within 1-3 min3†

    †flutiform® pMDI inhaler is not indicated for use as a reliever.3

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    †LS mean difference (flutiform® pMDI versus fluticasone propionate pMDI) was 0.07L [95% CI: 0.03, 0.11L, p < 0.001 (superiority)].4

    ‡LS mean difference (flutiform® pMDI versus fluticasone propionate/ salmeterol pMDI) 0.00L [95% CI: −0.04, 0.04L, p < 0.001 (non-inferiority)].4

    §flutiform® pMDI 100/10 μg b.i.d. shown non-inferior to fluticasone propionate/ salmeterol pMDI 100/50 μg b.i.d. for change in pre-dose FEV₁ from day 0 to day 84. During the extension phase, day 84 to day 252 (full-analysis set), flutiform® pMDI 100/10 μg b.i.d. provided sustained improvements in FEV₁ over 36 weeks, subsequently increased by 0.105 L from 1.85 L shown at day 84.5

    flutiform® pMDI 100/10 µg b.i.d. demonstrated acceptable tolerability over 36 weeks vs fluticasone propionate/ salmeterol 100/10 µg b.i.d.5

    Abbreviations: b.i.d., twice daily; CI, confidence interval; FEV₁, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; LABA, long-acting β₂ agonist; LS, least square; pMDI, pressurised metered-dose inhaler

     

    Clinical studies (children)

     

    flutiform® pMDI 50/5μg has demonstrated efficacy in children aged 5 and above.4,5

    ffLAIR4

     

     

     

    flutiform® pMDI 50/5 µg has demonstrated superiority to fluticasone propionate (FP) pMDI 50 µg and non-inferiority to fluticasone propionate/salmeterol (FP/SAL) pMDI 50/25 µg for change in FEV₁ from pre-dose at baseline to 2-hour post-dose over 12 weeks.4

    ffLAIR4: A randomised parallel-group trial to further evaluate the efficacy and safety of flutiform® pMDI 50/5 µg in the paediatric population

    View study design here Read the full article

     

     

     

     

    Abbreviations: AUC, area under the curve; FEV₁, forced expiratory volume in 1 second; FP, fluticasone; CI, confidence interval; FP/SAL, fluticasone/salmeterol; pMDI, pressurised metered-dose inhaler

    Key Outcomes:4

     

    flutiform® pMDI 50/5 µg was superior to FP pMDI and non-inferior to FP/SAL pMDI in the primary endpoint and in changes in pre-dose FEV₁ from baseline over the 12-week treatment period4

    LSMC Graph

    Adapted from Ploszczuk A, et al. 2018.

    Least squares mean change from predose FEV₁ at baseline to 2 hours post-dose over the 12-week treatment period, full analysis population.*Based on pre-specified non-inferiority margin of -0.1L.

    FEV₁ AUC₀₋₄ₕ week 12 Change in predose FEV₁ from baseline to week 12 Safety profile Asthma exacerbations Conclusions

    36-week paediatric trial study5

     

     

     

    flutiform® pMDI 50/5 μg improved lung function and asthma control compared to baseline, with comparable efficacy to fluticasone propionate/salmeterol (FP/SAL) pMDI 50/25 μg and demonstrated similar safety and tolerability profile vs fluticasone propionate/ salmeterol (FP/SAL) pMDI 50/25 μg in children aged 5 to 12 years5

    12-week open-label, randomised, controlled trial and 24-week extension to assess the efficacy and safety of flutiform® pMDI 50/5 μg in children with asthma5

    View study design here Read the full article

     

     

    Abbreviations: CI, confidence interval; FEV₁, forced expiratory volume in 1 second; FP/SAL, fluticasone/ salmeterol LS, least square; pMDI, pressurised metered-dose inhaler

    Key Outcomes:5

     

    The change in predose FEV₁ from day 0 to day 84 demonstrated that flutiform® pMDI 50/5 μg was non-inferior to FP/SAL pMDI 50/25 μg. LS mean treatment difference was −0.031 (95.35% CI, −0.093, 0.031; p = 0.026).5

    Mean FEV Graph

    Adapted from Emeryk A, et al. 2016

    Mean predose FEV₁ (with 95% CI) during the core study (per-protocol set)

    Safety profile Lung function Sustained lung function Plasma cortisol and height Conclusions

    Tolerability & safety profile

     

    flutiform® pMDI 50/5 µg demonstrated acceptable safety and tolerability during 12 weeks of randomised therapy compared with fluticasone propionate/ salmeterol pMDI 50/25 µg and throughout the 24-week extension phase in children with asthma.5

    inhalator
    Tolerability table
    Read the full article

    Adapted from Emeryk A, et al. 2016

    a Two cases of appendicitis considered not related to study medication. b Pneumonia, considered not related to study treatment.

    Abbreviations: b.i.d., twice daily; AE, adverse event; n, number of patients in a treatment group; SAE, serious adverse event

    Effects of flutiform® pMDI 50/5 µg on plasma cortisol, height, and exacerbations:5

     

    • No hypothalamic pituitary adrenal-axis suppression was observed.5
      • Plasma cortisol values were within the normal range at the beginning of the extension phase and remained stable up to study end in the majority of patients.
      • Mean and median plasma cortisol values remained stable over the 24 weeks.
    • Mean height increased by 2.8 cm during the extension phase.5
      • This change was as expected in children aged 4-12 years.
    • There were no cases of severe exacerbations.5
    table 1 table 2

    A post hoc analysis was conducted to evaluate any effect of flutiform® pMDI 50/5 μg on patient growth based on height and weight data between day 84 (extension start) and day 252 (extension end), with reference to standardised height and weight tables [National Center for Health Statistics – CDC, 2000].5

    Read the full article

    Find out more about the indication and dosing for flutiform® pMDI

    Discover more here

    Abbreviations: SD, standard deviation; pMDI, pressurised metered-dose inhaler; b.i.d., twice daily

    References

    1. Network GA. The Global Asthma Report, Auckland, New Zealand (2018).
    2. Dharmage SC, et al. Front Pediatr 2019;7:246.
    3. flutiform® SmPC. Last updated 13 April 2022. https://www.emcpi.com/pi/26954. Accessed 5 September 2022.
    4. Płoszczuk A, et al. Ther Adv Respir Dis 2018.
    5. Emeryk A, et al. Ther Adv Respir Dis 2016;10:324-37.
    6. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (Updated 3rd May 2022). Available at: https://ginasthma.org/wp-content/uploads/2022/05/GINA-Main-Report-2022-FINAL-22-05-03-WMS.pdf Accessed 5 September 2022.
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    ®: FLUTIFORM is the Trademark of Jagotec AG used under licence by Mundipharma.

    ®: The ‘lung’ logo, is a Registered Trademark of Mundipharma.

    Reporting adverse events

    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

    Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444 or drugsafetyUKandROI@mundipharma.com.