Beclometasone + formoterol + glycopyrronium

Articles · Refrigerated Storage · New Medicines ·
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Articles

Refrigerated Storage

Trimbow · Chiesi Limited

Chiesi Limited
Trimbow
Pressurised inhalation solution, 87 micrograms/5 micrograms/9 micrograms

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. Other in-use storage times and conditions are under the responsibility of the user.
120 and 180 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 Cheisi in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details

As described above
22nd May 2019
London MI Service

New Medicines

Trimbow · Asthma in adults not controlled on ICS + LABA or already controlled on ICS + LABA + LAMA

Information

Trimbow
Licence extension / variation and new strength
Chiesi
Not Known

Development and Regulatory status

Recommended for approval (Positive opinion)
Recommended for approval (Positive opinion)
None
Nov 20 · Recommended 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 20 · Is currently pre-registration in the EU [5].
Nov 17 · Will 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 19 · Chiesi 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 18 · PIII studies TRIMARAN (NCT02676076) and TRIGGER (NCT02676089) have completed but results are not currently available [3].
Mar 16 · PIII 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 16 · PIII 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].