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.”
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
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.
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.
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.
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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Last updated on: 11/11/2016
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