CAMBRIDGE, England,
September 11, 2017 /PRNewswire/
--
- First presentation of largest ever real-world
flutiform® study at European Respiratory Society
International Congress involving over 2,500 patients
- Proportion of patients with well-controlled asthma more than
doubled 12 months after switching to flutiform pMDI
New real-world data to be presented at the European Respiratory
Society (ERS) annual congress in Milan,
Italy, will show that the proportion of patients with
well-controlled asthma more than doubled 12 months after switching
to flutiform pMDI (pressurised metered dose inhaler) compared with
baseline.[1] flutiform (fluticasone
propionate/formoterol) is indicated for use as a maintenance
treatment for asthma patients aged 12 years and older where
ICS/LABA therapy is appropriate.
"This large study further extends
the body of evidence for flutiform, demonstrating its
safety and effectiveness profile
in patients in real life clinical practice
with improved asthma control and a
reduction in exacerbations compared with
baseline," commented Professor David Price, Chair of Primary Care Respiratory
Medicine at the University of Aberdeen,
Aberdeen, UK. "Real-world
evidence like this is essential to
complement data from randomised controlled
trials (RCTs) by evaluating
outcomes in asthma patients in everyday
clinical practice, as RCTs
investigate a subgroup of the asthma
population and adherence tends to be
unusually high."
Assessment of fluticasone
propionate/formoterol In Real life
Maintenance treatment (AffIRM) is the largest study
to date of flutiform, with over 2,500 patients
enrolled, and is part of Affinity, Mundipharma's
international collaborative research programme for flutiform.
In this one-year, non-interventional study of 2,539 asthma
patients, more than two thirds of patients had switched from
another ICS/LABA (either a fixed dose combination or free
combination of ICS plus LABA).[1]
The safety profile of flutiform pMDI in practice was consistent
with that demonstrated in clinical trials. Secondary analyses
demonstrated that the proportion of patients with controlled asthma
increased from 29.4% at baseline to 67.4% (last observation carried
forward) and the mean total Asthma Control Test score increased
from 16.3 to 20.4.[1]
In the year prior to enrolment, 64.2% patients were free from
severe asthma exacerbations compared with 90.2% during the study
period. flutiform pMDI was associated with improvements from
baseline in Asthma Quality of Life scores, adherence and
physician/patient
satisfaction.[1]
Sub-optimal asthma control remains a major problem in
Europe, with many patients
experiencing largely preventable symptoms that disrupt their daily
lives.[2] Research suggests that only 20% of patients in
Europe have controlled asthma
according to the GINA
definition.[2] In addition, poor
or improper inhaler technique in asthma patients can lead to
critical inhaler errors and are associated with reduced disease
control,[3],[4] worse asthma
outcomes[5] and an increase in hospital
visits.[3]
For further information, please
visit:
http://www.mundipharma.com/Press/RespiratoryResources/background
http://www.flutiform.com/medical-media/resource-centre
About the Mundipharma network
The Mundipharma global network of privately-owned independent
associated companies was founded in 1956 by doctors, and now
operates in over 120 countries worldwide. We are focused on
developing business partnerships to identify and accelerate
meaningful technology across an increasingly diverse portfolio of
therapy areas including respiratory, oncology, pain, and
biosimilars. Consistent with our entrepreneurial heritage, we like
to think we see what others don't by challenging conventional
wisdom and asking different and challenging questions. By working
in partnership with all our stakeholders, the Mundipharma network
develops medicines that create value for patients, payers and wider
healthcare systems.
For more information please visit:
http://www.mundipharma.com.
About flutiform
In Europe, flutiform is licensed
for the regular treatment of asthma when use of a combination
product (an inhaled corticosteroid [ICS] and a long-acting
β2-agonist [LABA]) is appropriate: for patients not adequately
controlled with an ICS and an 'as required' inhaled short-acting
β2-agonist or for patients already adequately controlled on both an
ICS and a LABA. It is available in countries across Europe including the UK, Germany, France, Spain, Netherlands and Italy. flutiform is available in 50/5μg
and 125/5μg strengths for adults and adolescents; 250/10μg strength
for adults only.[6]
About Asthma
Asthma is a chronic inflammatory disorder of the airways which
leads to recurrent episodes of wheezing, breathlessness, chest
tightness and coughing. Patients with poorly managed asthma are at
an increased risk of exacerbations, hospitalisation and death.
Poorly managed asthma can also have a huge impact on a person's
quality of life and day-to-day activities.[7]
About Vectura
Vectura, a FTSE250 company listed on the London Stock Exchange
(LSE: VEC), is an industry-leading device and formulation business
for inhaled airways products offering a uniquely integrated inhaled
drug delivery platform. With its extensive range of device
and formulation technologies, integrated capabilities and
collaborations, Vectura is a leader in the development of
inhalation products, increasing its ability to help patients
suffering from respiratory diseases.
Vectura has eight inhaled, four non-inhaled and ten oral
products marketed by partners with growing global royalty streams.
The group has a diverse portfolio of drugs in clinical
development, including a number of novel and generic programmes
which are partnered with several global pharmaceutical and
biotechnology companies including Hikma, Novartis, Sandoz,
Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer,
Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with
two wholly owned nebulised development programmes.
References:
1. Backer V, et al. Real-world study to evaluate the safety and
effectiveness of fluticasone propionate/formoterol (FP/FORM) in
patients with asthma. Abstract presented at European Respiratory
Society (ERS) annual congress, Milan,
Italy 2017 September 9- 13
[PA4037].
2. Price, D., Fletcher, M., van der
Molen, T. Asthma control and management in 8,000 European
patients: the REcognise Asthma and LInk to Symptoms and Experience
(REALISE) survey. Prim Care Respir J 2014;24:14009-.
doi:10.1038/npjpcrm.2014.9.
3. Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih
S, et al. Improper inhaler technique is associated with poor asthma
control and frequent emergency department visits. Allergy Asthma
Clin Immunol. 2013;9(1):8.
4. Baddar S, Jayakrishnan B, Al-Rawas OA. Asthma control:
importance of compliance and inhaler technique assessments. J
Asthma . 2014;51(4):429-34.
5. Price D, et al. "Inhaler errors in the CRITIKAL Study: type,
frequency and association with asthma outcomes". Journal of
Allergy and Clinical Immunology: In Practice.
2017;5(4):1071-1081
6. flutiform SmPC
7. European Respiratory Society. The European Lung White Book. 2013
Job code: MINT/RESP-17013
Date of preparation: September
2017