AstraZeneca Announces Study Results Show SYMBICORT Improves Lung Function in Pediatric Asthma Patients
November 11 2016 - 8:00AM
Business Wire
Latest efficacy and safety findings for
SYMBICORT presented at the American College of Allergy, Asthma
& Immunology 2016 Annual Scientific Meeting
Results from the international, multicenter
ChildHood Asthma Safety and
Efficacy (CHASE) 3 Phase III study showed that SYMBICORT®
(budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
80/4.5 micrograms significantly improved lung function in pediatric
patients between 6 to <12 years of age with asthma versus
budesonide 80 micrograms, demonstrating its appropriateness as
step-up therapy in this patient population.
The CHASE 3 Phase III study evaluated the efficacy and safety of
budesonide/formoterol in a pressurized metered dose inhaler (pMDI)
80/2.25 micrograms, and SYMBICORT pMDI 80/4.5 micrograms, compared
with budesonide pMDI 80 micrograms in children with asthma, ages 6
to <12 years, who were given two inhalations twice a day for 12
weeks. The children had previously received either medium-dose
inhaled corticosteroid (ICS) or ICS/ long-acting beta2-adrenergic
agonists (LABA). The primary efficacy endpoint was change from
baseline pre-dose (randomization) to 1-hour post-dose forced
expiratory volume in one second (FEV1) at week 12.
AstraZeneca conducted the CHASE 3 study after the US Food and
Drug Administration (FDA) requested additional data on budesonide
and formoterol, specifically regarding the impact of different
doses, in pediatric asthma patients between 6 to <12 years of
age.
The study results showed changes from baseline at week 12 in
1-hour post-dose FEV1 and 15-minute post-dose FEV1 were
significantly greater with SYMBICORT 80/4.5 micrograms two
inhalations twice daily versus budesonide 80 micrograms two
inhalations twice daily (both p≤0.015), but not
budesonide/formoterol 80/2.25 micrograms two inhalations twice
daily versus budesonide 80 micrograms two inhalations twice daily.
The change from baseline in 1-hour post-dose PEF (peak expiratory
flow) was superior at week 12 with SYMBICORT 80/4.5 micrograms
versus other treatments (p<0.05).
There were no notable differences in safety profiles between
either of the budesonide/formoterol doses and budesonide or between
the two budesonide/formoterol doses. Among the most common adverse
events, upper respiratory tract infection, pharyngitis, headache,
and vomiting were more frequent, with budesonide/formoterol doses
compared to the budesonide 80 micrograms dose.
The CHASE 3 results were submitted to the FDA and other health
authorities in accordance with regulatory requirements.
Gregory Keenan, Vice President, Medical Affairs and US Head
Medical Officer, said: “These safety and efficacy results from the
CHASE 3 study indicate SYMBICORT may offer an important asthma
treatment option for the appropriate pediatric populations. We look
forward to working with the regulatory authorities to help make
SYMBICORT available to this population of children with
asthma.”
INDICATIONS
SYMBICORT is indicated for the treatment of asthma in patients
12 years and older (also see Boxed WARNING).
SYMBICORT 160/4.5 is indicated for the maintenance treatment of
airflow obstruction in patients with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and emphysema.
SYMBICORT is NOT indicated for the relief of acute
bronchospasm.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
- WARNING: Long-acting
beta2-adrenergic agonists (LABA), such as formoterol,
one of the active ingredients in SYMBICORT, increase the risk of
asthma-related death. A placebo-controlled study with another LABA
(salmeterol) showed an increase in asthma-related deaths in
patients receiving salmeterol. This finding with salmeterol is
considered a class effect of LABA, including formoterol. Currently
available data are inadequate to determine whether concurrent use
of inhaled corticosteroids or other long-term asthma control drugs
mitigates the increased risk of asthma-related death from
LABA. Available data from controlled clinical trials
suggest that LABA increase the risk of asthma-related
hospitalization in pediatric and adolescent patients
- When treating patients with asthma,
prescribe SYMBICORT only for patients not adequately controlled on
a long-term asthma control medication, such as an inhaled
corticosteroid or whose disease severity clearly warrants
initiation of treatment with both an inhaled corticosteroid and
LABA. Once asthma control is achieved and maintained, assess the
patient at regular intervals and step down therapy (eg, discontinue
SYMBICORT) if possible without loss of asthma control, and maintain
the patient on a long-term asthma control medication, such as an
inhaled corticosteroid. Do not use SYMBICORT for patients whose
asthma is adequately controlled on low or medium dose inhaled
corticosteroids
- SYMBICORT is NOT a rescue medication
and does NOT replace fast-acting inhalers to treat acute
symptoms
- SYMBICORT should not be initiated in
patients during rapidly deteriorating episodes of asthma or
COPD
- Patients who are receiving SYMBICORT
should not use additional formoterol or other LABA for any
reason
- Localized infections of the mouth and
pharynx with Candida albicans has occurred in patients treated with
SYMBICORT. Patients should rinse the mouth after inhalation of
SYMBICORT
- Lower respiratory tract infections,
including pneumonia, have been reported following the inhaled
administration of corticosteroids
- Due to possible immunosuppression,
potential worsening of infections could occur. A more serious or
even fatal course of chickenpox or measles can occur in susceptible
patients
- It is possible that systemic
corticosteroid effects such as hypercorticism and adrenal
suppression may occur, particularly at higher doses. Particular
care is needed for patients who are transferred from systemically
active corticosteroids to inhaled corticosteroids. Deaths due to
adrenal insufficiency have occurred in asthmatic patients during
and after transfer from systemic corticosteroids to less
systemically available inhaled corticosteroids
- Caution should be exercised when
considering administration of SYMBICORT in patients on long-term
ketoconazole and other known potent CYP3A4 inhibitors
- As with other inhaled medications,
paradoxical bronchospasm may occur with SYMBICORT
- Immediate hypersensitivity reactions
may occur, as demonstrated by cases of urticaria, angioedema, rash,
and bronchospasm
- Excessive beta-adrenergic stimulation
has been associated with central nervous system and cardiovascular
effects. SYMBICORT should be used with caution in patients with
cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension
- Long-term use of orally inhaled
corticosteroids may result in a decrease in bone mineral density
(BMD). Since patients with COPD often have multiple risk factors
for reduced BMD, assessment of BMD is recommended prior to
initiating SYMBICORT and periodically thereafter
- Orally inhaled corticosteroids may
result in a reduction in growth velocity when administered to
pediatric patients
- Glaucoma, increased intraocular
pressure, and cataracts have been reported following the inhaled
administration of corticosteroids, including budesonide, a
component of SYMBICORT. Close monitoring is warranted in patients
with a change in vision or history of increased intraocular
pressure, glaucoma, or cataracts
- In rare cases, patients on inhaled
corticosteroids may present with systemic eosinophilic
conditions
- SYMBICORT should be used with caution
in patients with convulsive disorders, thyrotoxicosis, diabetes
mellitus, ketoacidosis, and in patients who are unusually
responsive to sympathomimetic amines
- Beta-adrenergic agonist medications may
produce hypokalemia and hyperglycemia in some patients
- The most common adverse reactions ≥3%
reported in asthma clinical trials included nasopharyngitis,
headache, upper respiratory tract infection, pharyngolaryngeal
pain, sinusitis, influenza, back pain, nasal congestion, stomach
discomfort, vomiting, and oral candidiasis
- The most common adverse reactions ≥3%
reported in COPD clinical trials included nasopharyngitis, oral
candidiasis, bronchitis, sinusitis, and upper respiratory tract
infection
- SYMBICORT should be administered with
caution to patients being treated with MAO inhibitors or tricyclic
antidepressants, or within 2 weeks of discontinuation of such
agents
- Beta-blockers may not only block the
pulmonary effect of beta-agonists, such as formoterol, but may
produce severe bronchospasm in patients with asthma
- ECG changes and/or hypokalemia
associated with nonpotassium-sparing diuretics may worsen with
concomitant beta-agonists. Use caution with the coadministration of
SYMBICORT
Please see full Prescribing Information, including
Boxed WARNING and Medication Guide.
NOTES TO EDITORS
About the CHASE 3 Study
The global, multicenter, 12-week, randomized, double-blind,
parallel-group CHASE 3 Phase III clinical trial evaluated the
efficacy and safety of budesonide/formoterol in a pressurized
metered dose inhaler (pMDI) 80/2.25 micrograms, and SYMBICORT®
(budesonide/formoterol fumarate dihydrate) Inhalation Aerosol pMDI
80/4.5 micrograms, compared with budesonide pMDI 80 micrograms, all
given two inhalations twice-daily, in children ages 6 to <12
years with asthma. The study randomized 279 children 6 to <12
years of age, from which 273 received treatment, and involved a
total of 88 study centers located in four countries.
The study is part of the CHASE program made up of three
pediatric clinical studies conducted to meet Pediatric Research
Equity Act (PREA) requirements, fulfill the terms of a Complete
Response Letter issued by the US Food and Drug Administration
(FDA), and respond to FDA feedback.
About Asthma
Asthma is a common, chronic condition in which inflammation and
narrowing of the airways may cause wheezing, breathlessness, chest
tightness and coughing. Despite current and available treatment
options, asthma continues to effect the health and day-to-day
lifestyles of more than 300 million children, men and women
worldwide. By 2020, asthma will likely increase in numbers to
affect as many as 400 million people.
About Respiratory
Respiratory is one of AstraZeneca’s main therapy areas. Our
strong pipeline has the potential to deliver up to seven launches
between 2016 and 2020. In respiratory disease, our aim is to
transform asthma and COPD treatment through inhaled combinations at
the core of care, biologics for the unmet needs of specific patient
populations, and scientific advancements in disease modification.
We are building on a 40-year heritage in respiratory disease, and
our capability in inhalation technology spans both pressurized
metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as
well as Co-Suspension™ Delivery Technology.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 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 Twitter
@AstraZenecaUS.
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