The primary endpoint for this eight-week, open-label, cross-over study of 236 patients with COPD was the demonstration of non-inferiority of UMEC/VI compared to TIO/OLO in improving lung function, as measured by trough FEV1 (Forced Expiratory Volume in 1 second) at week eight. This endpoint was met, and furthermore UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs. TIO/OLO 128mL; 95% CI: 28, 77; p < 0.001).
Both treatments demonstrated a comparable tolerability and safety profile with an overall incidence of on-treatment adverse events of 25% in the UMEC/VI group and 31% in the TIO/OLO group. The most frequently-reported adverse events were upper respiratory tract infections (UMEC/VI 8%; TIO/OLO 9%), cough (UMEC/VI 1%; TIO/OLO 1%) and diarrhoea (UMEC/VI 1%; TIO/OLO 1%).
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. 384 million people have COPD2 and it is estimated to become the 3rd leading cause of death worldwide by 2030.3 Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.
About the Head-to-Head Study
The Anoro Ellipta (umeclidinium/vilanterol 62.5mcg/25mcg; UMEC/VI) versus Stiolto Respimat (tiotropium/olodaterol 5mcg/5mcg; TIO/OLO) head-to-head study is the first direct comparison of two fixed-dose once-daily LAMA/LABA combination therapies for COPD.
The study involved 236 adult symptomatic (MMRC > /= 2) patients with
moderate COPD (post bronchodilator FEV1 ≤50 and ≥70% of predicted
value), not receiving inhaled corticosteroid therapy at inclusion in the
study, from 34 centres across
The study was an 8-week, multicentre, randomised, open-label, two-period cross-over design. After an initial two week run-in period, eligible patients were randomised to receive UMEC/VI (62.5/25 mcg one inhalation once-daily) via the Ellipta inhaler followed by TIO/OLO 5/5 mcg (2 puffs of TIO/OLO 2.5/2.5 mcg once-daily) via the Respimat inhaler (each for 8 weeks with an interim 3-week washout), or vice versa. Treatments were administered open-label, since the inhalers were potentially identifiable, but spirometry was conducted in assessor-blind conditions.
Commitment to respiratory disease
GSK has been a leader in respiratory for over 45 years, developing new and first-in-class medicines, approaches and insights which have helped to influence and support the management of asthma and COPD. The company is relentless in striving to expand knowledge and the understanding of respiratory disease to help transform the way that medicines are developed. GSK is focused on identifying new scientific insights, applying our expertise and developing innovative new medicines that enable clinicians to tailor treatment to the individual needs of patients and help patients to live every breath.
About Anoro Ellipta
Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is
a combination of two bronchodilators in a single dry powder inhaler, the
Ellipta. It contains umeclidinium (UMEC), a long-acting muscarinic
antagonist (LAMA) and vilanterol (VI), a long-acting beta2
agonist (LABA). The dose of UMEC/VI is labelled as 55/22mcg in
Important Safety Information for Anoro Ellipta in the US
The following Important Safety Information (ISI) is based on the Highlights section of the Prescribing Information for Anoro Ellipta. Please consult the full Prescribing Information for all the labeled safety information for Anoro Ellipta.
Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths. This finding with salmeterol is considered a class effect of all LABA. The safety and efficacy of Anoro in patients with asthma have not been established. Anoro is not indicated for the treatment of asthma.
Anoro is contraindicated in patients with severe hypersensitivity to milk proteins or any ingredients.
Anoro should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm, which should be treated with an inhaled, short-acting beta2-agonist.
Anoro should not be used more often than recommended, at higher doses than recommended, or in conjunction with additional medicine containing a LABA, as an overdose may result.
Anoro should be used with caution when considering coadministration with long-term ketoconazole and other known strong cytochrome P450 3A4 inhibitors because increased cardiovascular adverse effects may occur.
Anoro can produce paradoxical bronchospasm, which may be life-threatening.
Anoro should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Anoro should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Anoro should be used with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately should any signs or symptoms of narrow-angle glaucoma occur.
Anoro should be used with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder neck obstruction. Instruct patients to contact a physician immediately should any signs or symptoms of urinary retention occur.
Beta-adrenergic agonist medicines may produce significant hypokalemia and transient hyperglycemia in some patients.
The most common adverse reactions (incidence ≥1% and more common than placebo) with Anoro were pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.
Beta2-agonists, such as vilanterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated.
Use beta‐blockers with caution as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
Use with caution in patients taking non-potassium-sparing diuretics, as electrocardiographic changes and/or hypokalemia associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonists.
Avoid co-administration of Anoro with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects such as cardiovascular effects, worsening of narrow-angle glaucoma, and worsening of urinary retention.
Full US prescribing information is available at: US Prescribing Information for Anoro Ellipta.
GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
ANORO®, and ELLIPTA® are trade marks of the
1. Feldman G et al. Advances in Therapy 2017; vol. 34: DOI
2. GOLD 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD. Available from: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/ [Last accessed:
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2016.
This press release contains certain "forward-looking" statements as that
term is defined in the Private Securities Litigation Reform Act of 1995
regarding, among other things, statements relating to goals, plans,
objectives and future events, including the development, regulatory and
commercial plans for closed triple combination therapy and the potential
benefits and mechanisms of action of closed triple combination therapy.
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