IMPACT (European Union Clinical Trials Register : CTT116855 and ClinicalTrials.gov : NCT02164513) was a phase III, double-blind, parallel-group, 52-week, multicentre study in patients ≥40 years of age with symptomatic COPD and at least one moderate/severe exacerbation in the prior year. Patients were randomised 2:2:1 to FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg once daily via a single dry-power inhaler (ELLIPTA; GlaxoSmithKline, Brentford, UK) [10 (link)]. The study design and primary results have been previously published [10 (link)].
Ellipta
Manufactured by GlaxoSmithKline
Sourced in United Kingdom
The Ellipta is a dry powder inhaler device developed by GlaxoSmithKline. It is a single-use, disposable inhaler designed to deliver various respiratory medications directly to the lungs.
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5 protocols using ellipta
1
Impact of Combination Therapy in COPD
2
Efficacy of COPD Combination Therapies
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This was a multicentre, randomised controlled trial that included patients aged ≥40 years who either had a forced expiratory volume in 1 s (FEV1) that was <50% of the predicted normal value and a history of at least one moderate or severe AECOPD in the previous year, or an FEV1 of 50–80% of the predicted normal value and at least two moderate or one severe AECOPD in the previous year. The study was conducted in 37 countries. Patients were randomly assigned to one of three treatment arms: 1) a once-daily triple combination therapy of fluticasone furoate (an ICS) 100 µg, umeclidinium (a LAMA) 62.5 µg and vilanterol (a LABA) 25 µg; 2) a once-daily dual combination therapy of fluticasone furoate 100 µg and vilanterol 25 µg; or 3) a once-daily dual combination therapy of umeclidinium 62.5 µg and vilanterol 25 µg. Each treatment was given in a single dry-powder inhaler (Ellipta, GlaxoSmithKline). The primary outcome was the annual rate of moderate or severe AECOPD during treatment. A mild AECOPD was defined as worsening of symptoms treated with increased salbutamol. A moderate AECOPD was one treated with antibiotics or systemic glucocorticoids, and a severe AECOPD was one resulting in hospitalisation or death.
3
Comparing Inhaler Device Usability
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We compared five types of inhalers. The primary outcome was differences in the acceptable use ratio among inhaler devices. Secondary outcomes included differences in error correction after training, most common step of misuse, and factors affecting the accuracy of inhaler use. Further, we surveyed patient satisfaction with each device and found the most frequently error-prone steps. In this study, six inhaler device types were used by participants: Evohaler (GlaxoSmithKline, London, UK/Chiesi, Parma, Italy), Respimat (Boehringer Ingelheim, Ingelheim am Rhein, Germany), Turbuhaler (AstraZeneca, Lund, Sweden), Ellipta (GlaxoSmithKline), Breezhaler (Novartis, Basel, Switzerland), and Handihaler (Boehringer Ingelheim). However, Breezhaler and Handihaler were analyzed in the same group because of the similarities. Finally, five device types were compared.
4
Mortality and Cardiovascular Outcomes in COPD
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Details of the study have been published previously [2 (link), 8 (link)]. Briefly, this was a prospective, double-blind, parallel-group, placebo-controlled, event-driven, randomised trial conducted at 1368 centres in 43 countries. Participants had moderate COPD according to the Global Initiative for Chronic Obstructive Lung Disease and heightened cardiovascular risk. Participants were allocated equally to one of four treatments (placebo, FF (100 µg; GlaxoSmithKline, Brentford, UK), VI (25 µg; GlaxoSmithKline) or FF/VI (100/25 µg; Relvar/Breo, GlaxoSmithKline)) administered once daily as a dry powder with the use of an inhaler (Ellipta, GlaxoSmithKline). The primary outcome was mortality, and the secondary outcomes were on-treatment rates of decline in forced expiratory volume in 1 s (FEV1), and the on-treatment composite cardiovascular endpoint of cardiovascular death, myocardial infarction, stroke, unstable angina and transient ischaemic attack. All patients provided written informed consent. The study was approved by local ethics committees and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The study is registered at www.clinicaltrials.gov with identifier number NCT01313676.
5
COPD Treatments: Efficacy and Safety
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This was a prospective double blind parallel group placebo controlled event-driven randomised trial conducted at 1,368 centres in 43 countries. Participants were allocated equally to one of four treatments (placebo, fluticasone furoate (100 μg; GlaxoSmithKline), vilanterol (25 µg; GlaxoSmithKline) or the combination of fluticasone furoate and vilanterol (100/25 μg; Relvar ® /Breo ® , GlaxoSmithKline)) administered once daily as a dry powder with the use of an inhaler (Ellipta ® , GlaxoSmithKline).
The use of all inhaled corticosteroids and inhaled long-acting bronchodilators was discontinued at least 48 hours before study entry, although other COPD medications such as theophyllines were permitted (13) . Patients unable to tolerate withdrawal of therapy were excluded from study entry. After randomisation, patients were seen every 3 months to confirm vital status and record adverse events. Post-bronchodilator spirometry was performed every 3 months and health status was assessed at 3 months then every 6 months. An independent data monitoring committee (IDMC) performed safety reviews every 6 months, and one pre-defined interim efficacy analysis was performed after a total of approximately 500 deaths had occurred. The stopping guideline for efficacy was the Haybittle-Peto method (one-sided P value of 0•00005) in order to have a negligible impact on the final significance level.
The use of all inhaled corticosteroids and inhaled long-acting bronchodilators was discontinued at least 48 hours before study entry, although other COPD medications such as theophyllines were permitted (13) . Patients unable to tolerate withdrawal of therapy were excluded from study entry. After randomisation, patients were seen every 3 months to confirm vital status and record adverse events. Post-bronchodilator spirometry was performed every 3 months and health status was assessed at 3 months then every 6 months. An independent data monitoring committee (IDMC) performed safety reviews every 6 months, and one pre-defined interim efficacy analysis was performed after a total of approximately 500 deaths had occurred. The stopping guideline for efficacy was the Haybittle-Peto method (one-sided P value of 0•00005) in order to have a negligible impact on the final significance level.
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