Independent Data Monitoring Committee
recommended trial stop early due to overwhelming efficacy at
pre-planned analysis
AstraZeneca’s inhaled anti-inflammatory rescue
medication AIRSUPRA demonstrated significant benefit compared to
albuterol
Positive high-level results from the BATURA Phase IIIb trial
showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met
the primary endpoint, demonstrating a statistically significant and
clinically meaningful reduction in the risk of a severe
exacerbation when used as an as-needed rescue medication in
response to symptoms compared to as-needed albuterol.1 The trial
included patients with intermittent or mild persistent asthma,
including those on short-acting beta2-agonist (SABA) alone,
low-dose inhaled corticosteroid (ICS) maintenance therapy, or
leukotriene receptor antagonist (LTRA) maintenance therapy.
Asthma is a chronic, inflammatory respiratory disease with
variable symptoms that affects as many as 262 million people
worldwide,2 including over 25 million in the US.3 Patients with
mild asthma comprise at least 50% of the US asthma population and
are at risk of severe exacerbations.4,5
James Donohue, Emeritus Professor of Pulmonary Medicine,
University of North Carolina, and Chair, Independent Data
Monitoring Committee, said: “People with asthma are at risk of
severe exacerbations regardless of their disease severity or level
of control. By focusing on patients with intermittent or mild
persistent asthma, the strong BATURA trial results further
demonstrate the clinically meaningful benefit of an
anti-inflammatory rescue approach to reduce the risk of severe
exacerbations by treating both symptoms and inflammation at the
same time.”
Sharon Barr, Executive Vice-President, BioPharmaceuticals
R&D, AstraZeneca, said: “The impressive BATURA trial results
add to the body of evidence supporting AIRSUPRA as a first-in-class
rescue treatment and its role in reducing the risk of asthma
exacerbations in patients regardless of their disease severity, and
reducing the need for systemic corticosteroids.”
The safety and tolerability of AIRSUPRA in the BATURA trial was
consistent with its established profile and no new safety concerns
were reported. The data will be shared with health authorities and
will be presented as a late-breaker oral presentation at the
American College of Allergy, Asthma & Immunology (ACAAI) Annual
Scientific Meeting on October 26 2024.
AIRSUPRA is the first and only anti-inflammatory rescue
medication approved in the US for the as-needed treatment or
prevention of bronchoconstriction and to reduce the risk of
exacerbations in people with asthma aged 18 years and older.6 The
US approval was based on results from the MANDALA and DENALI Phase
III trials.7,8 AIRSUPRA is also being studied in adolescents with
asthma (12 to <18 years old) in the ACADIA Phase III trial and
in patients in China in the BAIYUN Phase III trial.9,10 AIRSUPRA is
being developed by AstraZeneca and Avillion.
APPROVED USE
AIRSUPRA combines 2 medicines to be used as needed as a rescue
inhaler in people 18 years of age and older to:
- treat or prevent symptoms of asthma
- help prevent sudden severe breathing problems (asthma attacks
or exacerbations)
IMPORTANT SAFETY INFORMATION
- Do not use AIRSUPRA if you are allergic to albuterol,
budesonide, or any of the ingredients in AIRSUPRA
- Before using AIRSUPRA, tell your healthcare provider
about all your medical conditions and about all the medicines you
take
- A dose of AIRSUPRA is 2 inhalations (puffs) as needed. Use
AIRSUPRA exactly as your healthcare provider tells you to use it.
Do not use AIRSUPRA more than 12 puffs (which equals
6 doses) within a 24-hour period
- AIRSUPRA is not to be used as a maintenance treatment for
asthma. If you are currently taking medicine long-term to
maintain control of asthma symptoms, you should continue to take
that medicine as directed by your healthcare provider
- Do not change or stop other inhaled medicines or asthma
medicines (oral or inhaled) without first talking to your
healthcare provider
- Call your healthcare provider or get emergency medical care
right away if your breathing problems get worse, you
need to use AIRSUPRA more often than usual, or AIRSUPRA does not
work as well to relieve your asthma
- AIRSUPRA can cause serious side effects, including:
- worsening trouble breathing, coughing, and wheezing
(paradoxical bronchospasm). If this happens, stop using
AIRSUPRA and call your healthcare provider or get emergency medical
care right away. This is more likely to happen with your first use
of a new canister of medicine
- heart problems, including faster heart rate and higher blood
pressure
- possible death in people who use too much AIRSUPRA
- serious allergic reactions. Tell your healthcare
provider or get emergency medical care right away if you have a
skin rash, redness, or swelling; severe itching; swelling of the
face, mouth, or tongue; trouble breathing or swallowing; or chest
pain
- changes in laboratory blood levels. Low levels of
potassium (hypokalemia) may cause abnormal heart rhythms
- weakened immune system and increased chance of getting
infections
- fungal infection in your mouth and throat (thrush). This
is a common side effect. Rinse your mouth with water, if available,
without swallowing after using AIRSUPRA to help reduce your chance
of getting thrush
- reduced adrenal function (adrenal insufficiency). This
can happen when you start taking a medicine containing an inhaled
corticosteroid (such as AIRSUPRA)
- bone thinning or weakness (osteoporosis)
- eye problems, including glaucoma and cataracts. Your
healthcare provider may suggest having regular eye exams while
using AIRSUPRA. Discuss any eye problems with your healthcare
provider
- Common side effects include headache, cough, and
hoarseness. These are not all the side effects of AIRSUPRA. For
more information, ask your healthcare provider or pharmacist
Please see full Prescribing Information and
Patient Information and discuss with your doctor.
You may report side effects related to AstraZeneca products.
Notes
Asthma
Asthma is a chronic, inflammatory respiratory disease with
variable symptoms that affects as many as 262 million people
worldwide,2 including over 25 million in the US.3
Patients with asthma experience recurrent breathlessness and
wheezing, which varies over time, and in severity and frequency.11
These patients are at risk of severe exacerbations regardless of
their disease severity, adherence to treatment or level of
control.12,13 There are an estimated 136 million asthma
exacerbations globally per year,14 including more than 10 million
in the US;3 these are physically threatening and emotionally
significant for many patients15 and can be fatal.2,16
Inflammation is central to both asthma symptoms12 and
exacerbations.17 Many patients experiencing asthma symptoms use a
SABA (e.g. albuterol) as a rescue medicine;18-20 however, taking a
SABA alone does not address inflammation, leaving patients at risk
of severe exacerbations,21 which can result in impaired quality of
life,22 hospitalisation23 and frequent oral corticosteroid (OCS)
use.23 Treatment of exacerbations with as few as 1-3 short courses
of OCS are associated with an increased risk of adverse health
conditions including type 2 diabetes, depression/anxiety, renal
impairment, cataracts, cardiovascular disease, pneumonia and
fracture.24 International recommendations from the Global
Initiative for Asthma no longer recommend SABA alone as the
preferred rescue therapy.11
BATURA
BATURA is a Phase IIIb, US, randomised, double-blind,
parallel-group, event-driven trial, comparing the efficacy and
safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an
as-needed rescue medication in response to symptoms compared to
as-needed albuterol (180mcg) for up to 12 months. Patients
recruited were aged 12 years and over with intermittent or mild
persistent asthma and must have been using as-needed SABA alone, or
as-needed SABA on a background of either low-dose ICS or LTRA
maintenance therapy.25
The primary efficacy endpoint was the time to first severe
asthma exacerbation during the study period. Secondary endpoints
included severe exacerbation rate and total systemic corticosteroid
use.25
AIRSUPRA
AIRSUPRA (albuterol/budesonide), formerly known as PT027, is a
first-in-class SABA/ICS rescue treatment for asthma in the US, to
be taken as needed. It is an inhaled, fixed-dose combination rescue
medication containing albuterol (also known as salbutamol), a SABA,
and budesonide, a corticosteroid, and has been developed in a
pressurised metered-dose inhaler (pMDI) using AstraZeneca’s
Aerosphere delivery technology.6
Outside of the US, AIRSUPRA is also approved in the United Arab
Emirates, Kuwait, Bahrain, Qatar and Oman.
AstraZeneca’s Collaboration with Avillion
In March 2018, AstraZeneca and Avillion signed an agreement to
advance AIRSUPRA through a global clinical development program for
the treatment of asthma. Under the terms of the agreement, Avillion
became the trial sponsor responsible for executing and funding the
global, multicentre, clinical trial program for AIRSUPRA through
NDA filing to a regulatory decision in the US. Following the
successful approval of AIRSUPRA, AstraZeneca is commercializing the
medicine. AstraZeneca extended its agreement with Avillion in 2022
to undertake the BATURA Phase IIIb trial to further assess the role
of AIRSUPRA in reducing the risk of asthma exacerbations.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 125 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
social media @AstraZeneca.
References
- Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically
important difference for asthma endpoints: an expert consensus
report. Eur Respir Rev. 2020; 29: 190137.
- Global Asthma Network. The Global Asthma Report 2022. [Online].
Available at:
http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf.
Accessed September 2024.
- CDC. Most Recent National Asthma Data. [Online]/ Available at:
https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm.
Accessed September 2024.
- Quint JK, et al; SABINA North American and European Study
contributors. Short-Acting Beta-2-Agonist Exposure and Severe
Asthma Exacerbations: SABINA Findings From Europe and North
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- Pollack M, et al. The use of short-acting bronchodilators and
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- Chipps BE, et al. Efficacy and safety of albuterol/budesonide
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of PT027 Compared With PT007 in Symptomatic Chinese Adults With
Asthma (BAIYUN). Available at
https://clinicaltrials.gov/study/NCT06471257?term=BAIYUN&rank=1.
Accessed September 2024.
- Global Initiative for Asthma. Global strategy for asthma
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Accessed September 2024.
- Price D, et al. Asthma control and management in 8,000 European
patients: the REcognise Asthma and LInk to Symptoms and Experience
(REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.
- Papi A, et al. Relationship of inhaled corticosteroid adherence
to asthma exacerbations in patients with moderate-to-severe asthma.
J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3.
- AstraZeneca Pharmaceuticals. Data on File.
Budesonide/formoterol Data on File: Annual Rate of Asthma
Exacerbations Globally. (REF-173201)
- Sastre J, et al. Insights, attitudes, and perceptions about
asthma and its treatment: a multinational survey of patients from
Europe and Canada. World Allergy Organ J. 2016; 9: 13.
- Fernandes AG, et al. Risk factors for death in patients with
severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.
- Wark PA, et al. Asthma exacerbations· 3: pathogenesis. Thorax.
2006; 61 (10): 909-15.
- Johnson DB, et al. Albuterol. 2022 May 1. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan.
PMID: 29489143.
- Montemayor T, et al. Albuterol: Often Used and Heavily Abused.
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- ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020.
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Accessed September 2024.
- Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma
is associated with increased risk of exacerbation and mortality: a
nationwide cohort study of the global SABINA programme. Eur Respir
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- Lloyd A, et al. The impact of asthma exacerbations on
health-related quality of life in moderate to severe asthma
patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7.
- Bourdin A, et al. ERS/EAACI statement on severe exacerbations
in asthma in adults: facts, priorities and key research questions.
Eur Respir J. 2019; 54 (3): 1900900.
- Price DB, et al. Adverse outcomes from initiation of systemic
corticosteroids for asthma: long-term observational study. J Asthma
Allergy. 2018; 11: 193–204.
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https://clinicaltrials.gov/study/NCT05505734?cond=asthma%20&term=BATURA&rank=1
Accessed September 2024.
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