Abbreviations: ICS, inhaled corticosteroid; LABA, long-acting β₂ agonist; pMDI, pressurised metered-dose inhaler; SABA, short-acting β₂ agonist
Discover flutiform® pMDI
flutiform® pMDI is a fixed-dose combination of a potent inhaled corticosteroid steroid (ICS), fluticasone propionate, and formoterol fumarate – a fast-acting LABA. It is indicated in the regular treatment of asthma where the use of a combination product is appropriate:5
- For patients not adequately controlled with an ICS and ‘as required’ inhaled SABA.5
- For patients already adequately controlled on an ICS and a LABA.5
5 things you need to know about flutiform® pMDI
flutiform® pMDI has demonstrated improved asthma control compared to baseline, and low incidence of severe asthma exacerbations across randomised controlled trials (2.1%)4 and different real-world evidence studies2-3
1
Improved asthma control across different real-world evidence studies1-3
-
More than 4,000 patients were enrolled in real-world evidence studies over 3 and 12 months1-3
- ffLUX Study1^
- ffAIRNESS Study2¶
- AffIRM Study3#
2
Warmer, less forceful plume vs fluticasone propionate/ salmeterol pMDI6
- Which may reduce the amount of drug deposition at the back of the throat and lead to improved lung deposition.6
5
Low incidence of severe asthma exacerbations4*
- Long-term flutiform® pMDI therapy is associated with a low rate of severe asthma exacerbations (2.1%).4*
Click the link below to find out more information on tolerability.
4
Fast-acting LABA5†
- Onset of bronchodilation within 1-3 min.5†
†flutiform® inhaler is not indicated for use as a reliever.5
3
High lung deposition throughout both central and peripheral airways:7‡
The mean drug deposition fractions and standard deviations (SDs) in the entire lung:
- ICS: 46.18% ± 1.29%,
- LABA: 44.34% ± 1.23%
The mean drug deposition fractions and standard deviations (SDs) in the peripheral airways:
- ICS: 30.33% ± 1.89%
- LABA: 29.17% ± 1.81%
*Pooled exacerbation rate from two open-label studies with fixed dose flutiform® pMDI administered for between 26 to 60 weeks in adults and adolescents with asthma (95% CI: 1.1, 3.2%). Exacerbations treated with an oral, intramuscular, or intravenous corticosteroid.4
‡In an in-vitro lung deposition study, using Functional Respiratory Imaging, flutiform® pMDI 125/5 μg was tested at an inspiratory flow rate of 30 L/min.7
§Based on Asthma Control Test score ≥ 20.2,3
^A significantly higher proportion of patients achieved controlled asthma after switching from fluticasone propionate/ salmeterol pMDI to flutiform® pMDI.1
¶The percentage of patients with well-controlled asthma more than doubled, from 30.9% to 65.3%, after 12 months.2
#The percentage of patients with controlled asthma went from 29.4% to 67.4% at the end of a 12-month study.3
Abbreviations: CI, confidence interval; ICS, inhaled corticosteroid; LABA, long-acting β₂ agonist; pMDI, pressurised metered-dose inhaler
How flutiform® pMDI demonstrates favourable plume characteristics6
flutiform® pMDI 125/5 μg has a slower, less forceful and warmer plume than fluticasone proprionate/ salmeterol pMDI, which may reduce the amount of drug deposition at the back of the throat and lead to improved lung deposition.6
Plume velocity
Mean maximum velocity of flutiform® pMDI plume was 30% slower than the fluticasone propionate/ salmeterol pMDI plume.6
The clinical relevance of these findings has not been established.
Adapted from Johal B, et al. 2015
Data from an in vitro study; mean maximum velocities (from three readings) observed across the three distances measured. Statistical analyses were not performed for these data.6
Abbreviation: pMDI, pressurised metered-dose inhaler
Plume duration
The average plume duration for flutiform® pMDI was almost 50% longer than fluticasone propionate/ salmeterol pMDI plume.6
The clinical relevance of these findings has not been established.
Data from an in vitro study. Plume duration is derived from intensity, and analysis of the relative normalised intensity over time showed that:6
- fluticasone propionate/ salmeterol pMDI 125/25 μg delivered a large peak 20 ms after actuation, which declined rapidly. Approximately, 25% of the intensity appeared within the first 23 ms, 50% within 40 ms, and 75% by 61 ms.6
- By contrast, flutiform® pMDI 125/5 μg peaked at around 40 ms and declined at a slower rate. The intensity developed and was maintained over a longer period of time with 25% of the dose appearing within 38 ms, 50% within 59 ms, and 75% within 87ms.6
Abbreviation: pMDI, pressurised metered-dose inhaler
Plume temperature
flutiform® pMDI plume was warmer than fluticasone propionate/ salmeterol pMDI plume.6
flutiform® pMDI plume impaction temperature was +5.9°C vs -37.8°C for fluticasone propionate/ salmeterol pMDI (at a distance of 25 mm).6
The clinical relevance of these findings has not been established.
Adapted from Johal B, et al. 2015
Data from an in vitro study. Graph shows data for two independent measurements for each drug (first actuation), normalised for a 22°C ambient temperature.6
Abbreviation: pMDI, pressurised metered-dose inhaler
flutiform® pMDI delivers high fine particle fraction12
flutiform® pMDI consistently delivers a high fine particle fraction of ~40% for both ICS and LABA in vitro regardless of inspiratory flow rate.12
Adapted from Johal B, et al. 2015
Aerodynamic particle size distribution was determined for each product using an 8-stage Anderson Cascade Impactor at two inhalation flow rates: 28.3 and 60.0 L/min. Fine particle dose (mass of dose <5.0 μm) and FPF were calculated as a percentage of the labelled dose for the LABA and ICS of each product at both flow rates.12
Abbreviations: DPI, dry powder inhaler; FPF, fine particle fraction; ICS, inhaled corticosteroid; LABA, long-acting β₂ agonist; pMDI, pressurised metered-dose inhaler
Lung deposition
flutiform® pMDI provided higher particle deposition* of ICS & LABA in central & peripheral airways in vitro vs budesonide/ formoterol (DPI) & fluticasone furoate/ vilanterol (DPI).7
The clinical relevance of these findings has not been established.
Adapted from Iwanaga T, et al. 2017
This is an in vitro study, using Functional Respiratory Imaging.
* An entire lung deposition of 46.18% ± 1.29% for ICS and 44.34% ± 1.23% for LABA. Deposition in the peripheral airways of 30.33% ± 1.89% for ICS and 29.17% ± 1.81% for LABA.
Abbreviations: ICS, inhaled corticosteroid; LABA, long-acting β₂ agonist; DPI, dry powder inhaler; pMDI, pressurised metered-dose inhaler
Discover the inhaler with three strengths and a colour-coded dose counter
flutiform® pMDI is available in three dosing strengths to meet the patient’s needs5
Learn how to use flutiform® inhaler
Abbreviations: b.i.d., twice daily; pMDI, pressurised metered-dose inhaler
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References
- Usmani OS, et al. J Allergy Clin Immunol Prac 2017;5:1378-87.
- Schmidt O, et al. Respir Med 2017;131:166–74.
- Backer V, et al. Ther Adv Respir Dis 2018:12;1-16.
- Papi A, et al. J Aerosol Med Pulm Drug Deliv. 2016;29:346–361.
- flutiform® SmPC. Last updated 13 April 2022. https://www.emcpi.com/pi/26954. Accessed 5 September 2022.
- Johal B, et al. Adv Ther. 2015;32(6):567–79.
- Iwanaga T, et al. Pulm Ther 2017;3:219-231.
- Marwick JA, et al. Am J Respir Crit Care Med. 2009;179:542–8.
- Prasad SVN, et al. J Cell Biol. 2002;158(3):563–75.
- Rossios, et al. Br J Pharmacol 2012;167:775-86.
- Adner M, et al. J Pharmacol Exp Ther. 2010;333:273–80.
- Johal B, et al. Comb Prod Ther. 2013;3:39–51.
®: FLUTIFORM is the Trademark of Jagotec AG used under licence by Mundipharma.
®: The ‘lung’ logo, is a Registered Trademark of Mundipharma.