Beyond randomised clinical trials: The real-world impact of Fostair (beclometasone/formoterol) NEXThaler® 100/6 on asthma control

Uncontrolled asthma persists as a major burden in the UK.1-3 Findings from a newly published real-world study of Fostair NEXThaler 100/6 highlight its role in improving asthma management in everyday practice.4

The pervasive burden of uncontrolled asthma in the UK1–3

Uncontrolled asthma is not only a clinical challenge; it is a significant burden impacting the UK’s healthcare system and, more importantly, patients’ lives.1–3

Nearly half (48%) of patients with asthma struggle with uncontrolled symptoms annually, requiring oral steroids or use of multiple reliever inhalers – indicating suboptimal disease management.3

The consequences extend beyond the struggle with symptoms to life-threatening events.1,2 Asthma exacerbations account for over 65,000 hospital admissions each year, placing substantial strain on the healthcare system.2 And sadly, four people lose their lives every day to asthma attacks.1

But the impact of uncontrolled asthma is not limited to these critical events and the strain on resources.1,2,5 Uncontrolled asthma also diminishes a patient’s health-related quality of life, negatively impacting many dimensions of a patient’s life, including mental function, depression, and distress.5

Despite these sobering statistics,1–3,5 many patients, and even healthcare professionals (HCPs), overestimate how well the condition is controlled, particularly in more severe asthma.6 In a cross-sectional UK study, ~84% of patients and ~74% of HCPs believed that asthma was controlled, however, asthma control test (ACT) results suggest actual control in only ~55% of patients (ACT score ≥20).6

Perceptions of asthma control6

 

Adapted from Menzies-Gow A, et al. 2017.6

Achieving complete asthma control in patients’ everyday lives requires a critical re-evaluation of current treatment strategies – the most effective regimen requires thoughtful selection of both the medication and delivery device.7

The NEWTON study: real-world impact of Fostair NEXThaler 100/64

The NEWTON study was a multinational, observational, prospective cohort study evaluating Fostair NEXThaler 100/6 in adults with not well-controlled or poorly controlled asthma (n=423).4

The NEWTON study provides real-world evidence on this treatment, reporting improvements in asthma control (primary endpoint), moderate-severe exacerbation rate, lung function, quality of life (QoL) and treatment adherence vs. baseline. ~80% (n=307) of patients were generally satisfied with the NEXThaler device.4

Rapid and significant asthma control outcomes reported4,8

Two-thirds (66%; n=261/395; 95% CI: 61.2 to 70.7) of patients who completed the asthma control questionnaire (ACQ-5) reported achieving improved asthma control within six months of treatment with Fostair NEXThaler 100/6 compared to baseline, a key finding emphasising clinical effectiveness (primary endpoint).

Asthma control4

Adapted from Braido F, et al. 2025.4

The study also showed (secondary endpoint):4

  • The proportion of patients with not-well-controlled or poorly controlled asthma was more than halved, dropping from 87.6% (n=346) to 43.3% (n=171) in six months
  • Gains in asthma control were observed rapidly before stabilising, with similar positive results already evident at three months (median ACQ-5 decreased from 2.2 at baseline vs. 0.8 at 3 months; p<0.0001).

Explore the full study paper.

Read more

Further key findings from the NEWTON study

  • Significant improvements in lung function outcomes vs. baseline4

    After six months, patients showed statistically significant improvements across key lung function parameters when taking Fostair NEXThaler 100/6. This included improvements in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), mean forced expiratory flow between 25% and 75% of FVC (FEF25%-75%), and peak expiratory flow (PEF) at six months vs. baseline (p<0.0001 for all)* (secondary endpoint).

     

    *Key lung function parameters included median FEV1 (% of predicted; n=150), FVC (% of predicted, n=151), FEF25%-75% (% of predicted, n=100), and PEF (% of predicted, n=125).4

  • Significant improvements in QoL vs. baseline4

    NEWTON demonstrated a significant improvement in patients’ QoL with Fostair NEXThaler 100/6 vs. baseline, as assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L) index. This improvement was evident within three months (n=354), with patients reaching a score of 1 (indicating full health) by six months (n=391) (p<0.0001) (secondary endpoint).

  • In a sub-group analysis, more patients achieved ‘good adherence’ vs. baseline4

    NEWTON reported notable improvements in treatment adherence with Fostair NEXThaler 100/6 vs. baseline. The proportion of patients demonstrating ‘good adherence’ increased significantly, rising from 31.7% (n=99) to 50% (n=156) at three months, and from 30.4% (n=105) to 49.9% (n=172) at six months from baseline with Fostair NEXThaler 100/6 (secondary endpoint).

     

    Treatment adherence4

     

     

    Adapted from Braido F, et al. 2025.4

  • Patients were satisfied with the Fostair NEXThaler 100/6 device4

    Patient satisfaction with the NEXThaler device was high after six months of treatment (secondary endpoint). The majority of patients (n=387) reported being completely or very satisfied with:

     

    ● Its ease of use (81.1%) (n=314)
    ● The delivered dose check (83.7%) (n=324)
    ● And the device in general (79.3%) (n=307)

     

    These positive feelings were consistently observed even at three months, highlighting user acceptance and experience

  • Safety profile and asthma exacerbation rate4

    The study showed the tolerability of Fostair NEXThaler 100/6 was as expected, with no new safety concerns emerging. Importantly, Fostair NEXThaler 100/6 was associated with a reduction in the rate of moderate-to-severe asthma exacerbations, which decreased from 13% in the 12 months prior to the study, to 3% by the end of the observation period, showing a substantial improvement in disease stability (secondary endpoint).

Key takeaway

The persistent burden of uncontrolled asthma in the UK demands timely and effective intervention for these patients.1–3,5 Fostair NEXThaler 100/6 may provide significant benefits,8 now with demonstrated asthma control in the real world for the first time.4

To learn more about how Fostair NEXThaler 100/6 can help your patients with asthma achieve the control they need, speak to your Chiesi representative today.

 

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UK-RES-2102745 - November 2025

Fostair NEXThaler 100/6 is indicated in the regular treatment of asthma in adults where use of a combination product (inhaled corticosteroid and long-acting β2-agonist) is appropriate:8

  • patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled rapid-acting β2-agonist, or
  • patients already adequately controlled on both inhaled corticosteroids and long-acting β2-agonists.

ACT: asthma control test; CI: confidence interval; EQ-5D-5L: EuroQol 5-dimension 5-level; FEF25%–75%: mean forced expiratory flow between 25% and 75% of FVC; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; HCP: healthcare professional; PEF: peak expiratory flow; QoL: quality of life; UK: United Kingdom.

References

1. Asthma + Lung UK. Welcome to Asthma + Lung UK. Available at https://www.asthmaandlung.org.uk/conditions/asthma/what-asthma

2. NHS England. Specialised Respiratory Services (adult) – Severe Asthma. 2017. Available at https://www.england.nhs.uk/publication/specialised-respiratory-services-adult-severe-asthma/

3. Asthma + Lung UK. Transforming asthma care in the UK: Fighting Back 2022. Available at https://www.asthmaandlung.org.uk/sites/default/files/Fighting%20back_V3.pdf

4. Braido F, et al. Respir Med. 2025: 108224.

5. Ilmarinen P, et al. Sci Rep. 2019; 9(1): 16107.

6. Menzies-Gow A, et al. NPJ Prim Care Respir Med. 2017; 27(1): 48.

7. Björnsdóttir US, et al. Int J Clin Pract. 2013; 67(9): 904–910.

8. Fostair NEXThaler 100/6 Summary of Product Characteristics. Chiesi Limited.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.