Welcome to this UK AstraZeneca produced and funded website

This website is intended for UK Healthcare professionals only.

 

The website contains both promotional and non-promotional content.

 

If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk

 

For any other UK residents please visit astrazeneca.co.uk

I am not a Healthcare Professional
Prescribing Information TRIXEO®
(formoterol fumarate dihydrate/ glycopyrronium/budesonide)
Prescribing Information SYMBICORT®
(budesonide/formoterol) COPD 200/6 and 400/12
Prescribing Information BEVESPI®
(glycopyrronium/formoterol fumarate dihydrate)
Adverse Event
Reporting

This website is intended for UK Healthcare Professionals only. Other UK residents please visit astrazeneca.co.uk

global-header-image
  • Products
    • Forxiga® (dapagliflozin)
    • Lokelma® (sodium zirconium cyclosilicate)
    • IMFINZI® (durvalumab)
    • IMJUDO®▼ (tremelimumab)
    • Symbicort® (budesonide/formoterol)
    • Tezspire®▼ (tezepelumab)
    • Trixeo Aerosphere® (formoterol fumarate dihydrate/glycopyrronium/budesonide)
  • Therapeutic Areas
    • Cardiovascular
    • Metabolic
    • Renal
    • Respiratory
  • About us
    • AZ Commitment
  • Contact us
  • AstraZeneca UK
  • TRIXEO
  • AEROSPHERE technology
  • TRIXEO AEROSPHERE
    About TRIXEO AEROSPHERE Efficacy Safety How to use
  • About COPD
    COPD exacerbations
  • AEROSPHERE technology
  • For you and your patient

Efficacy Safety How to use

COPD exacerbations
AEROSPHERE technology For you and your patient

AEROSPHERE®  Technology

AEROSPHERE next generation device delivery technology is offered in both TRIXEO (ICS/LABA/ LAMA) and BEVESPI (LABA/LAMA), providing pMDI device and molecular continuity to patients.1,2

TRIXEO (ICS/LABA/LAMA)

Discover TRIXEO

BEVESPI (LAMA/LABA)

Discover BEVESPI

AEROSPHERE particles mechanism of action

AEROSPHERE technology is enabled by innovative, porous particles made of phospholipids, a major component of lung surfactant.3-5 These particles are optimally sized at 1 to 2 micrometres, and deliver inhaled therapies throughout the lungs for COPD treatment.3

 

To find out more about AEROSPHERE technology, watch this video:7-10,14

 

Their light foam nanostructure enhances aerodynamics and aerosolization and a corrugated surface allows drug crystals to attach to the particles in the right proportions for dose uniformity.3  The drug crystals remain attached to the surface after actuation, to ensure effective delivery throughout the lung.3,5 This technology also reduces potential drug-drug interactions for multi-drug combinations within a single inhaler device.6

undefined

AEROSPHERE technology offers:3,4,6–11,14

  • Effective, consistent delivery to the whole lung, both large and small airways
  • A stable homogenous suspension that delivers a consistent dose
  • Optimally sized vehicles for delivering inhaled drugs
  • Consistent deposition of drug combination in the airways
  • AEROSPHERE technology offers a lung deposition rate of 38% to 41%
More information on how to use the inhaler
AEROSPHERE technology offers

logo

BEVESPI AEROSPHERE:

A LAMA/LABA that provides dual bronchodilation to the whole lung9-14
BEVESPI AEROSPHERE is indicated as a maintenance bronchodilator treatment 
to relieve symptoms in adult patients with COPD2

Outcomes from clinical trials

Improved lung function vs placebo (measured by morning pre-dose trough FEV1 and peak FEV1 over and at 24 weeks).2,12

 

ONSET OF ACTION12

At 5 minutes following administration of the first dose on day 1, there was significant improvement in FEV1 from baseline vs placebo (in PINNACLE-1 and PINNACLE-2 studies respective differences were 187 and 186 mL, all p<0.0001)2,12

INNOVATIVE AEROSPHERE DELIVERY TECHNOLOGY4

Aerosphere technology enables effective, consistent dose delivery to the whole lung with lung deposition of 38.4% with BEVESPI AEROSPHERE.4¶

IMPROVEMENTS IN FEV112,15*

BEVESPI AEROSPHERE demonstrated statistically significant improvements in trough FEV1 at 24 weeks vs both monocomponents12,13,15

QUALITY OF LIFE2,12,15

Improvement of Health-related quality-of-life (SGRQ scores) with Bevespi was statistically but not clinically significant at Week 24 vs placebo in PINNACLE-1, PINNACLE-2, and PINNACLE-4 trials.2,12‡

The most common adverse reactions reported in the clinical development program (comprised of 1,588 patients receiving Bevespi Aerosphere) were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).2 The most common adverse reactions from the SmPC were anxiety, headache, dizziness, dry mouth, nausea, muscle spasms, urinary tract infection and chest pain.2 Please refer to the SmPC for the full list of adverse events.2

*PINNACLE 1: 59 mL vs glycopyrrolate and 64 mL vs formoterol (both p<0.0001); PINNACLE 2: 54 mL vs glycopyrrolate (p<0.0003) and 56 mL vs formoterol (p<0.0002); PINNACLE 4: 59 mL vs glycopyrrolate and 72 mL vs formoterol (both p<0.0001).

‡Health-related quality of life was measured using the SGRQ. An improvement of 4 points in the SGRQ total score is the minimal clinically important difference.12

¶Based on a phase 1 trial of radiolabelled BEVESPI vs radiolabelled placebo pMDI (n=10). The dose detected in the oropharyngeal and stomach regions was 61% and 67% for BEVESPI and placebo, respectively.4

FEV1, forced expiratory volume in first second; FRI, functional respiratory imaging; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; SGRQ, St George’s Respiratory Questionnaire, pMDI, pressurised metered dose inhaler; COPD, chronic obstructive pulmonary disease, n, number of patients

  1. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics.
  2. BEVESPI AEROSPHERE 5 micrograms/7.2 micrograms pressurised inhalation, suspension. Summary of Product Characteristics.
  3. Vehring R et al. Cosuspensions of microcrystals and engineered microparticles for uniform and efficient delivery of respiratory therapeutics from pressurized metered dose inhalers. Langmuir. 2012;28(42): 15015–15023. doi: 10.1021/la302281n.
  4. Taylor G et al. Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology. Eur J Pharm Sci. 2018;111: 450–457. doi: 10.1016/j.ejps.2017.10.026.
  5. Fernandez-Tena A et al. Deposition of inhaled particles in the lungs. Arch Bronconeumol. 2012;48(7): 240–246. doi: 10.1016/j.arbres.2012.02.003.
  6. Ferguson GT et al. Co-suspension delivery technology in pressurized metered-dose inhalers for multi-drug dosing in the treatment of respiratory diseases. Respir Med. 2018;134: 16–23. doi: 10.1016/j.rmed.2017.09.012.
  7. De Backer LA et al. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018;13: 2673–2684. doi: 10.2147/COPD.S171707.
  8. Marshall J, et al. Poster presented at: ATS International Conference, May 19-24, 2023; Washington, DC. P406.
  9. van den Berge M et al. Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD. Presented at the CHEST 2020 Virtual Congress, October 2020. P1456.
  10. Usmani OS et al. Consistent Pulmonary Drug Delivery with Whole Lung Deposition Using the Aerosphere Inhaler: A Review of the Evidence. Int J Chron Obstruct Pulmon Dis. 2021 16:113-124. doi: 10.2147/COPD.S274846. PMID: 33500616; PMCID: PMC7822085.
  11. Israel S et al. Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects. Eur J Pharm Sci. 2020 153:105472. doi: 10.1016/j.ejps.2020.105472. Epub 2020 Jul 16. PMID: 32682074.
  12. Martinez FJ et al. Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD. Chest. 2017 151(2):340-357. doi: 10.1016/j.chest.2016.11.028. PMID: 27916620.
  13. Reisner C et al. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017 18(1):157. doi: 10.1186/s12931-017-0636-4. PMID: 28821260; PMCID: PMC5563048.
  14. Usmani et al. Respiratory Research. 2023; 24:226
  15. Lipworth BJ et al. Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA. Int J Chron Obstruct Pulmon Dis. 2018 13:2969-2984. doi: 10.2147/COPD.S171835. PMID: 30310273; PMCID: PMC6167125.

GB-57038 | November 2024

TRIXEO and AEROSPHERE are registered trademarks of the AstraZeneca group of companies.

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 AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling ‌‌‌0‌‌‌8‌‌‌‌‌0‌‌‌‌0‌‌‌ ‌‌7‌‌‌‌‌‌8‌‌‌3‌‌‌ ‌‌0‌‌‌‌‌0‌‌‌‌3‌‌‌‌3‌‌‌.

Connessiallasalute.it

This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.

Terms of use

Privacy Policy

Cookie Policy

Contact Us

LinkedIn

Twitter

©2024 AstraZeneca. GB-59678 | DOP: November 2024