dm+d

34855311000001107

Articles

Ethanol content of inhalers – What is the significance?

13 December 2019Ethanol is included as an excipient in many commonly prescribed inhalers, including some licensed for use in children.  Patients may have ethical, religious or cultural…
Search Articles

Refrigerated Storage

Trimbow Chiesi Ltd

Chiesi Ltd
Trimbow
87 micrograms/5 micrograms/9 micrograms pMDI

In the event of an inadvertent temperature excursion the following data may be used:
60 actuation pressurised container: After dispensing, the medicinal product may be stored for a maximum of 2 months at a temperature up to 25°C.

120 actuation pressurised container: After dispensing, the medicinal product may be stored for a maximum of 4 months at a temperature up to 25°C.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Contact Chiesi Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.

24 September 2021
London MI Service

New Medicines

TrimbowAsthma in adults not controlled on ICS + LABA or already controlled on ICS + LABA + LAMA

Information

Trimbow
Licence extension / variation and new formulation
Chiesi
Not Known

Development and Regulatory status

Launched
Launched
None
January 2021
May 21MHRA approves high-strength Trimbow inhaler for maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. This strength (172 micrograms/5 micrograms/9 micrograms) is not yet available in the UK. Each metered dose (the dose leaving the valve) contains 200 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms glycopyrronium bromide) [8,9].
Jan 21New indication approved in UK and EU for Trimbow medium strength inhaler (BDP 87mcg + FF 5mcg + GB 9mcg per puff). New indication for high-strength inhaler (172mcg + 5mcg + 9mcg) approved in the EU, but not yet UK [7].
Nov 20Recommended for EU approval by CHMP - the additional indication is "Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year." A new strength has also been licensed, beclometasone 172 mcg / formoterol 5 mcg / glycopyrronium bromide 9 mcg, that is indicated only for asthma [6].
Apr 20Is currently pre-registration in the EU [5].
Nov 17Will be filed in the EU via the centralised procedure. Currently PIII in EU [2].

Category

Fixed-dose combination of a corticosteroid (CS), long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA).
5.4 million people in the UK receive treatment for asthma: 1 in 11 children and 1 in 12 adults [1].
Asthma in adults not controlled on ICS + LABA or already controlled on ICS + LABA + LAMA
Inhalation

Trial or other data

Oct 19Chiesi Farmaceutici released the pre-specified pooled analysis efficacy and safety data from PIII TRIMARAN (NCT02676076) and TRIGGER (NCT02676089) trials [4]. Study authors concluded that by week 26, BDP/FF/G improved pre-dose FEV1 by 57mL (95% CI 15–99; p=0.0080) and 73mL (26–120; p=0.0025) versus BDP/FF in TRIMARAN and TRIGGER, respectively, with 15% (rate ratio 0.846 [0.725–0.987]; p=0.0331) and 12% (0.880 [0.751–1.030]; p=0.1102) reductions in moderate-to-severe exacerbation rate over 52 weeks [4]. BDP/FF/G reduced the rate of severe exacerbations vs. BDP/FF by 23% (p=0.0076), reduced the rate of moderate exacerbations by 12% (p=0.0427), and reduced the rate of combined moderate and severe exacerbations by 14% (p=0.0083) [4].
Dec 18PIII studies TRIMARAN (NCT02676076) and TRIGGER (NCT02676089) have completed but results are not currently available [3].
Mar 16PIII TRIGGER trial to evaluate the superiority of beclometasone + formoterol + glycopyrrolate (200/6/12.5µg), compared with beclometasone + formoterol (200/6µg) and beclometasone + formoterol (200/6µg) in combination with tiotropium (2.5µg), followed by assessment of its safety and health economic outcomes in patients with asthma starts (NCT02676089). The randomized, double-blind trial is designed to enrol approximately 1,435 patients in Western Europe. Collection of primary outcome data (pre-dose FEV1 and moderate and severe exacerbation rate) is expected to complete Jul 18 [2,3].
Feb 16PIII study to evaluate safety and efficacy of beclometasone + formoterol + glycopyrrolate (100/6/12.5 µg), with beclometasone + formoterol (100/6/µg), in patients with asthma that is uncontrolled on medium strength regimen of inhaled corticosteroids plus long acting β agonist starts (TRIMARAN; NCT02676076). Approximately 1148 subjects, aged 18 to 75 years, will be enrolled in the trial. Enrolment is underway in Western European counties including the UK. Collection of primary outcome data (pre-dose FEV1 and moderate and severe exacerbation rate) is expected to complete Jun 18 [2,3].

Evidence based evaluations

SMC

Trimbow NEXThaler Chronic obstructive pulmonary disease (COPD) - dry powder inhaler

Information

Trimbow NEXThaler
New formulation
Chiesi
Not Known

Development and Regulatory status

Launched
Approved (Licensed)
None
September 2021
Sep 21Launched in UK. Price £44.50 x 1 120 dose inhaler [10].
Apr 21European Commission grants marketing authorisation for Trimbow® inhalation powder delivered through NEXThaler (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium), an extrafine formulation triple fixed combination therapy in a single dry powder inhaler (DPI), for the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist [9].
Jul 20Currently pre-registration in EU. Has been filed using the centralised procedure [8].

Category

Fixed-dose combination of a corticosteroid (CS), long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA).
About 1.2 million people are affected by COPD in the UK. There are 115,000 new diagnoses a year. However, 60-85% of patients, mainly with mild-to-moderate disease, are thought to remain undiagnosed [4].
Chronic obstructive pulmonary disease (COPD) - dry powder inhaler
Inhalation

Trial or other data

Dec 20No further development reported [5,6,7].
Mar 19NCT03590379 has completed but results are not yet available [3].
Apr 18PII study to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD starts (NCT03590379). 354 adults will be recruited in Eastern Europe. Collection of primary outcome data is expected to complete Jan 19 [1,2].