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UK-RES-2101606 August 2021

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UK-RES-2101574 August 2021


Fostair in COPD Evidence Summary

The following Fostair evidence summary provides you with information that will assist in your prescribing decision.
Mechanisms of action and pharmacodynamic effects

Fostair contains beclometasone dipropionate and formoterol. These two active ingredients have different modes of action.1

Beclometasone dipropionate
Beclometasone dipropionate given by inhalation at recommended doses has a glucocorticoid anti-inflammatory action within the lungs.1

Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect sets in rapidly, within 1–3 minutes after inhalation, and has a duration of 12 hours after a single dose.1

Fostair pMDI 100/6


In two 48-weeks studies, the effects on lung function and the rate of exacerbation (defined as courses of oral steroids and/or course of antibiotics and/or hospitalisations) in patients with severe COPD (30% <FEV1%<50%).

One pivotal trial showed a significant improvement in lung function (primary endpoint: pre-dose FEV1) compared to formoterol after 12 weeks of treatment (adjusted mean difference between Fostair and formoterol: 69 ml) as well as at each clinic visit during the whole treatment period (48 weeks). The study demonstrated that the mean number of exacerbations per patient/year (exacerbation rate, co-primary endpoint) was statistically significantly reduced with Fostair as compared with formoterol treatment (adjusted mean rate 0.80 compared with 1.12 in the formoterol group, adjusted ratio 0.72, p<0.001) over 48 weeks treatment period in a total of 1,199 patients with severe COPD. In addition, Fostair statistically significantly prolonged the time to first exacerbation compared to formoterol. The superiority of Fostair versus formoterol was also confirmed in terms of exacerbation rate in subgroups of patients taking (around 50% in each treatment arm) or not Tiotropium Bromide as concomitant medication.1

The other pivotal study, which was a three arm, randomised, parallel group study in 718 patients, confirmed the superiority of Fostair versus formoterol treatment in terms of change in pre-dose FEV1 at the end of treatment (48 weeks) and demonstrated the non-inferiority of Fostair compared to budesonide/formoterol fixed dose combination on the same parameter.1

Fostair NEXThaler 100/6

An open-label placebo study was conducted to verify that the inspiratory flow which could be generated through the NEXThaler inhaler is not influenced by patient’s age, disease and disease severity, and therefore the activation and drug delivery from the device could be achieved in all patients. The primary endpoint was the percentage of patients in each age and disease group able to activate the inhaler. Eighty-nine patients, in the age range 5–84 years, including moderate and severe asthmatics (FEV1 > 60% and ≤ 60% predicted, respectively), and moderate and severe COPD patients (FEV1 ≥ 50% and < 50% predicted, respectively) participated in the trial. All patients, irrespective of age, disease and disease severity, were able to generate sufficient inspiratory flow to activate the NEXThaler inhaler.2

In an additional open label placebo study it was demonstrated by assessing the inspiration profile through the Fostair NEXThaler that mild to severe COPD patients, regardless of their functional limitation, were able to effectively activate and use the device.2

COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in one second; pMDI: pressurised metered dose inhaler.

1. Fostair pMDI 100/6 Summary of Product Characteristics. Chiesi Limited.
2. Fostair NEXThaler 100/6 Summary of Product Characteristics. Chiesi Limited.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Ltd on 0800 0092329 (UK), 1800 817459 (IE) PV.UK@Chiesi.com.