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Release your adult asthma patients experiencing symptoms on ICS/LABA from constriction with TRELEGY Ellipta
Significantly improves lung function
vs. an ICS/LABA (FF/VI)¹*
p < 0.001
Enables more patients to improve
asthma control vs. an ICS/LABA (FF/VI)¹†
*N=2436; FF /UMEC 62 .5mcg /VI statistically significantly improved trough FEV 1 versus FF / VI for each corresponding FF dose (100 /62 .5 /25mcg vs FF /VI 100 / 25mcg: 110mL [95 %CI 66-153], 200 /62 .5 /25mcg vs FF /VI 200 /25mcg: 92mL [95 %CI: 49-135]; all p<0 .001)
† Numerical reduction in exacerbation rate observed for FF /UMEC 62 .5mcg /VI versus FF/VI (rate ratio [95 %CI]: 0 .87 [0 .72-1.05]). ACQ-7 responder rates were greater for FF /UMEC 62 .5mcg /VI versus FF /VI (63 % vs 55 %; OR 1 .43; 95 %CI: 1.16-1.76); there were no differences in SGRQ responder rates (69 %, vs 66 %; OR 1 .14; 95 %CI: 0 .92-1 .42).
-
CAPTAIN study design²
Design: The CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) trial was a 24- to 52-week, randomised, double-blind, active-controlled, parallel-group, multicentre study of 2,436 patients that evaluated the safety and efficacy of TRELEGY Ellipta (FF/UMEC/VI) 100/62.5/25 OD and TRELEGY Ellipta (FF/UMEC/VI) 200/62.5/25 OD compared to ICS/LABA (FF/VI) 100/25 OD and ICS/LABA (FF/VI) 200/25 OD.
Primary endpoint2
Mean change from baseline in trough FEV₁ at Week 24Key secondary endpoint2
Annualised rate of moderate/severe asthma exacerbationsOther secondary endpoints2
ACQ-7 responder rates at Week 24Key safety endpoints2
Incidence and type of adverse eventsInclusion criteria3
- Adults (aged ≥18 years) with uncontrolled or inadequately controlled asthma despite ICS/LABA maintenance therapy (ACQ-6 score ≥1.5)
- Patients were required to have been on daily ICS/LABA therapy for ≥12 weeks prior to screening, with a stable dose of >250 mcg/day FP or equivalent in the 6 weeks prior to screening
- A.M. pre-bronchodilator FEV₁ ≥30% and <85% of predicted, and FEV₁ reversibility ≥12% and ≥200 mL
Exclusion criteria3
- Participants unable to withhold SABA for the 6-hour period prior to spirometry testing at each study visit
- Asthma exacerbation requiring a change in maintenance therapy
- Current or former smokers (smoking history of ≥10 pack years)
- Evidence of COPD, pneumonia or other concurrent respiratory disorders
Run-in period
2,436 patients were randomised to treatment after a 5-week run-in and stabilisation period. During this period, patients received fluticasone propionate/salmeterol 250/50 mcg twice daily for 3 weeks followed by fluticasone furoate/vilanterol 100/25 mcg once daily for 2 weeks.¹,³
Clinically meaningful improvements during pre-randomisation phases³
With TRELEGY Ellipta, more than 60% of patients achieve a clinically meaningful improvement from baseline in asthma control1,3,5
ACQ-7 responders are defined as patients who achieved the minimal clinically important difference (MCID) in ACQ-7 of ≥0.5 point (decrease) from baseline at Week 245
Result not adjusted for multiplicity
Consistent results were demonstrated with ACQ-6 and ACQ-52,3
ACQ-7 responders are defined as patients who achieved the minimal clinically important difference (MCID) in ACQ-7 of ≥0.5 point (decrease) from baseline at Week 245
Result not adjusted for multiplicity
Consistent results were demonstrated with ACQ-6 and ACQ-52
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Safety Information:
Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate and magnesium stearate) or patients with severe milk-protein allergy. Warnings & Precautions: Asthma: Should not be used to treat acute asthma symptoms or an acute exacerbation in COPD for which a short-acting bronchodilator is required. COPD: Should not be used to treat an acute exacerbation in COPD for which a short-acting bronchodilator is required. Patients should not stop therapy with Trelegy Ellipta, in asthma or COPD, without physician supervision since symptoms may recur after discontinuation. Discontinue Trelegy if paradoxical bronchospasm occurs and institute alternative therapy if necessary. Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists or sympathomimetics, use with caution in patients with unstable or life-threatening cardiovascular disease. Monitor patients with moderate to severe hepatic impairment for systemic corticosteroid-related adverse reactions and the 100/62.5/25 micrograms dose should be used. Systemic effects may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Possible systemic effects include HPA suppression, decrease in bone mineral density, cataract, glaucoma, central serous chorioretinopathy and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Use with caution in patients with urinary retention, narrow angle glaucoma, pulmonary tuberculosis or with chronic or untreated infections. hyperglycaemia and severe hepatic impairment. Consider risk factors for pneumonia in patients with COPD before prescribing, and re-evaluate treatment if pneumonia occurs. Adverse Reactions: Very Common: Nasopharyngitis. Common: Urinary tract infection, sinusitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, dysphonia, constipation, pneumonia, bronchitis, rhinitis, influenza, candidiasis of mouth and throat, arthralgia, back pain, viral respiratory tract infection. Uncommon: dry mouth, dysgeusia, atrial fibrillation, supraventricular tachyarrythmia, tachycardia, fractures.
Version number: GDS12/IPI13a(SI)
Footnotes
ACQ, Asthma Control Questionnaire; BD, twice daily; CI, confidence interval; FEV₁, forced expiratory volume in one second; FF, fluticasone furoate; FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting β₂-adrenergic agonist; MCID, minimal clinically important difference; OD, once daily; OR, odds ratio; SABA, short-acting β₂-adrenergic agonist; SAL, salmeterol; UMEC, umeclidinium; VI, vilanterol
TRELEGY Ellipta is indicated for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a LABA and ICS.8
References
- Pavord I et al. Abstract 785. J Allergy Clin Immunol 2020; 145:AB241.
- Lee LA et al. Lancet Respir Med 2021; 9(1): 69-84.
- Lee LA et. al. Lancet Respir Med 2021; 9(1): 69-84. Supplementary Index.
- Hanania N et al. J Allergy Clin Immunol 2020; 145:AB24.
- Kerstjens HA et al. Am J Respir Crit Care Med 2020; 201:A4209.
- Juniper EF et al. Respir Med 2005; 99:553–558.
- Juniper EF et al. Eur Respir J 1999; 14:902–907.
- Juniper EF et al. Respir Med 2006; 100:616–621.
- TRELEGY Ellipta Singapore Prescribing Information GDS12/IPI13a (SI).
Adverse events should be reported. For reporting of adverse events, please write to sg.drugsafety@gsk.com.
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Trademarks are owned by or licensed to the GSK group of companies.
PM-SG-FVU-WCNT-240016 | April 2024
