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- Equivalent Systemic Exposure to Fluticasone Propionate/Salmeterol Following Single Inhaled Doses from Advair Diskus and Wixela Inhub: Results of Three Pharmacokinetic Bioequivalence Studies. [Journal Article]J Aerosol Med Pulm Drug Deliv 2019JA
- CONCLUSIONS: Wixela Inhub was bioequivalent to Advair Diskus at all three dose strengths for both FP and S, providing direct evidence of equivalent systemic safety and indirect evidence for equivalent pulmonary deposition.
- Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. [Randomized Controlled Trial]Respir Res 2019; 20(1):4RR
- CONCLUSIONS: Although there were gender differences in baseline characteristics, IND/GLY demonstrated similar trends for exacerbation prevention and lung function improvement in men and women with moderate-to-very-severe COPD and a history of exacerbations compared with SFC. Small differences in the effects seen between genders may be attributed to the different sizes of the two groups and need to be further evaluated in randomized trials that are appropriately powered for gender analysis.
- Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study. [Randomized Controlled Trial]Int J Chron Obstruct Pulmon Dis 2018; 13:3923-3936IJ
- CONCLUSIONS: IND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.
- Indacaterol/Glycopyrronium versus Salmeterol/Fluticasone in Patients with COPD-A Cost-Effectiveness Analysis in the Czech Republic. [Journal Article]Value Health Reg Issues 2018; 16:112-118VH
- CONCLUSIONS: From the perspective of the Czech health care system, managing COPD using IND/GLY is cost-effective in this analysis because the base-case is clearly below the willingness-to-pay threshold in the Czech Republic, which is automatically set at 3 times GDP/capita (approximately €44,000/ QALY). This is the first available economic analysis utilizing FLAME study results in the Central East European (CEE) countries showing IND/ GLY as a highly cost-effective investment into COPD patients.
- Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial. [Randomized Controlled Trial]Respirology 2018; 23(12):1152-1159R
- CONCLUSIONS: FLASH demonstrated that a direct switch to IND/GLY from SFC improved pre-dose FEV1 and FVC in COPD patients with up to one exacerbation in the previous year. No new safety signals were identified.
- Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. [Randomized Controlled Trial]Respir Res 2018; 19(1):121RR
- CONCLUSIONS: IND/GLY reduced the risk of CID versus SFC. CID had a significant impact on long-term exacerbation outcomes in patients with moderate-to-very severe COPD and a history of ≥1 exacerbations in the previous year.
- Post-radiotherapy maintenance treatment with fluticasone propionate and salmeterol for lung cancer patients with grade III radiation pneumonitis: A case report. [Case Reports]Medicine (Baltimore) 2018; 97(21):e10681M
- CONCLUSIONS: This maintenance therapy of FP/Salm for patient with grade III RP may help avoid relapse when steroid therapy is tapered, particularly for patients with a history of COPD. It may also reduce risk of steroid-associated adverse effects. Based on the results observed with our patient, we intend to design a prospective trial to assess the efficacy of FP/Salm when used as preventive treatment for patients at high risk of RP, and when used as maintenance treatment for patients with grade III RP.
- Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial. [Randomized Controlled Trial]Am J Respir Crit Care Med 2018; 198(3):329-339AJ
- CONCLUSIONS: In patients with COPD without frequent exacerbations on long-term triple therapy, the direct de-escalation to indacaterol/glycopyrronium led to a small decrease in lung function, with no difference in exacerbations. The higher exacerbation risk in patients with ≥300 blood eosinophils/μl suggests that these patients are likely to benefit from triple therapy. Clinical trial registered with www.clinicaltrials.gov (NCT 02603393).
- Exacerbation heterogeneity in COPD: subgroup analyses from the FLAME study. [Randomized Controlled Trial]Int J Chron Obstruct Pulmon Dis 2018; 13:1125-1134IJ
- CONCLUSIONS: Overall, IND/GLY demonstrated consistent beneficial effects versus SFC on moderate/severe exacerbations, independent of prior exacerbation history or treatment. The efficacy of IND/GLY on exacerbation prevention was superior to SFC for exacerbations treated with antibiotics with/without systemic corticosteroids and was similar for exacerbations treated with systemic corticosteroids alone.
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- Fluticasone Propionate/Salmeterol MDPI (AirDuo RespiClick®): A Review in Asthma. [Review]Clin Drug Investig 2018; 38(5):463-473CD
- The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick®) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β2-adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 1…
The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick®) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β2-adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 113/14 and 232/14 μg, respectively). In 12-week, phase III trials in patients aged ≥ 12 years with persistent asthma, all three dosages of fluticasone propionate/salmeterol MDPI treatment produced significant improvements in lung function and other asthma symptoms compared with fluticasone propionate MDPI monotherapy or placebo MDPI. In a 26-week, phase III trial in this patient population, mid- and high-dosage fluticasone propionate/salmeterol MDPI were noninferior to mid- (250/50 μg) and high- (500/50 μg) dosage fluticasone propionate/salmeterol DPI (Advair Diskus®), respectively, in terms of improvements in lung function. Treatment-emergent adverse events (TEAEs) with fluticasone propionate/salmeterol MDPI were mostly of mild to moderate severity, with no severe TEAEs deemed to be treatment related. Although long-term pharmacovigilance is required to fully establish its safety, given the ease of use and favorable characteristics of the device and its clinical efficacy at relatively low metered doses of the active moieties, fluticasone propionate/salmeterol MDPI is an important emerging treatment option in patients aged ≥ 12 years with asthma.