Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD

Martínez, Fernando J.; Rabe, Klaus F.; Ferguson, Gary T.; Fabbri, Leonardo M.; Rennard, Stephen I.; Feldman, Gregory; Sethi, Sanjay; Spangenthal, Selwyn; Gottschlich, Gregory; Rodríguez-Roisin, Roberto; Arora, Samir; Siler, Thomas; Siddiqui, Shahid; Darken, Patrick; Fischer, Tracy; Maes, Andrea; Golden, Michael A.; Orevillo, Chad; Reisner, Colin

doi:10.1016/j.chest.2016.11.028

Cited by 96 publications

(173 citation statements)

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“…These findings are generally aligned with the established characteristics of US and European patients with COPD in clinical studies of LAMA/LABA FDCs. [11][12][13][14][15] The majority of patients (75.3%) who had used an inhaled medication in the 12 months prior to the index date used a short-acting bronchodilator with or without maintenance treatment; 76.3% of these patients used a pMDI. Overall, the use of pMDIs was common in…”

Section: Discussionmentioning

confidence: 99%

“…6 LAMA/LABA FDC therapies currently approved for the maintenance treatment of COPD in the USA are umeclidinium/vilanterol 62.5/25.0 µg (Anoro ® Ellipta ® ; approved December 2013), 7 tiotropium/olodaterol 5.0/5.0 µg (Stiolto ® Respimat ® ; approved May 2015), 8 glycopyrrolate/formoterol fumarate 18/9.6 μg (Bevespi Aerosphere™; approved April 2016), 9 and indacaterol/glycopyrrolate 27.5/15.6 µg (Utibron™ Neohaler ® ; approved October 2015). 10 These treatments have demonstrated benefits in patients with moderate-to -very severe COPD for lung function and health status, including patient-reported outcomes, versus placebo [11][12][13][14] and their specific monocomponents. [11][12][13][14][15] Real-world evidence on prescribing trends and clinical characteristics of patients initiating treatment with LAMA/ LABA FDC therapies is generally limited to data from studies that focus on the effectiveness of treatment in the period following initiation, 16,17 or is confined to evaluations of a very limited number of FDC therapies, as determined by limited clinical availability in the study population.…”

Section: Introductionmentioning

confidence: 99%

“…10 These treatments have demonstrated benefits in patients with moderate-to -very severe COPD for lung function and health status, including patient-reported outcomes, versus placebo [11][12][13][14] and their specific monocomponents. [11][12][13][14][15] Real-world evidence on prescribing trends and clinical characteristics of patients initiating treatment with LAMA/ LABA FDC therapies is generally limited to data from studies that focus on the effectiveness of treatment in the period following initiation, 16,17 or is confined to evaluations of a very limited number of FDC therapies, as determined by limited clinical availability in the study population. 16,18 To our knowledge, this is the first study to describe the demographic and clinical characteristics, healthcare resource utilization (HCRU), and treatment patterns in patients with COPD in the USA who have initiated any LAMA/LABA FDC treatment.…”

Section: Introductionmentioning

confidence: 99%

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<p>Patient Characteristics and Healthcare Resource Utilization Among Patients with COPD New to LAMA/LABA Fixed-Dose Combination Treatment in US-Based Real-World Practice</p>

Ding

Kallenbach

Slipski

et al. 2020

COPD

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Introduction: This retrospective, observational cohort study utilized an integrated dataset from an electronic health records system and a claims database to describe demographic and clinical characteristics, healthcare resource utilization (HCRU), and treatment patterns in COPD patients initiating long-acting muscarinic antagonist (LAMA)/long-acting β 2 -agonist (LABA) fixed-dose combination (FDC) treatment in the USA. Methods: Patients were aged ≥40 years and had a COPD diagnosis (Practice Fusion system) and ≥1 prescription of LAMA/LABA FDC therapy, with an index date (first prescription) 1 May 2014-31 December 2017. For the HCRU analysis, patients had ≥2 claims from the Symphony Health database within 12 months before index. All analyses of outcomes relating to demographic and clinical characteristics, HCRU, and treatment patterns were descriptive. Results: Patients initiating LAMA/LABA FDCs (n=8224) had a mean age of 67.9 years, 52.8% were female, and mean BMI was 29.2 kg/m 2 . The most common comorbidities were cardiovascular disease (74.3%), hypertension (64.0%), and hyperlipidemia (45.6%). In the 12 months prior to index, 53.1% of patients had used inhaled therapy: 23.4% short-acting therapy only, 16.7% short-acting and maintenance therapy, and 13.1% maintenance therapy only. Amongst users of inhaled therapies, the pMDI was the most frequently used device (64.3%, n=2812/4370). Of 7050 patients included in the HCRU analysis, 79.8% had COPDrelated costs; mean cost/patient was $4174. Mean COPD-related costs per patient for moderate and severe exacerbations were $910 and $23,208, respectively. Per-patient costs included $23,032 for inpatient visits, $2358 for emergency visits, $4432 for outpatient visits, and $1989 for pharmacy claims. Conclusion: This observational study is the first to describe the real-world demographic and clinical characteristics and HCRU of patients initiating LAMA/LABA FDC treatment in the USA. Patients were generally elderly and overweight, with comorbidities of CVD, hypertension, and hyperlipidemia. Inpatient visits were the largest contributor to COPD-related costs per patient in the year prior to initiation of LAMA/LABA FDCs.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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<p>Patient Characteristics and Healthcare Resource Utilization Among Patients with COPD New to LAMA/LABA Fixed-Dose Combination Treatment in US-Based Real-World Practice</p>

Ding

Kallenbach

Slipski

et al. 2020

COPD

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“…In patients with moderate-to-very severe COPD, twice-daily GFF MDI 18/9.6 μg (equivalent to glycopyrronium/formoterol fumarate dihydrate 14.4/10 μg) improved lung function and reduced hyperinflation, as demonstrated by improvements in inspiratory capacity (IC) 12–14…”

Section: Introductionmentioning

confidence: 99%

A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD

Backer¹,

Backer²,

Vos³

et al. 2018

COPD

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BackgroundFunctional respiratory imaging (FRI) uses high-resolution computed tomography (HRCT) scans to assess changes in airway volume and resistance.Patients and methodsIn this randomized, double-blind, 2-week, crossover, Phase IIIB study, patients with moderate-to-severe COPD received twice-daily glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler (GFF MDI, 18/9.6 μg) and placebo MDI, formulated using innovative co-suspension delivery technology. Co-primary endpoints included the following: specific image-based airway volume (siVaw) and specific image-based airway resistance (siRaw) at Day 15, measured using FRI. Secondary and other endpoints included the following: change from baseline in post-dose forced expiratory volume in 1 second (FEV1) and inspiratory capacity (IC; spirometry) and ratio to baseline in post-dose functional residual capacity (FRC) and residual volume (RV; body plethysmography).ResultsTwenty patients (46–78 years of age) were randomized and treated; of whom 19 completed the study. GFF MDI treatment increased siVaw by 75% and reduced siRaw by 71% vs placebo MDI (both P<0.0001). Image-based airway volume (iVaw) and image-based airway resistance (iRaw), without adjusting for lobe volume, demonstrated corresponding findings to the co-primary endpoint, as lobe volumes did not change with either treatment. Approximately 48% of the delivered dose of glycopyrronium and formoterol fumarate was estimated to be deposited in the lungs. Compared with placebo, GFF MDI treatment improved post-dose FEV1 and IC (443 mL and 454 mL, respectively; both P<0.001) and reduced FRC and RV (13% and 22%, respectively; both P<0.0001). There were no significant safety findings.ConclusionGFF MDI demonstrated significant, clinically meaningful benefits on FRI-based airway volume and resistance in patients with moderate-to-severe COPD. Benefits were associated with improvements in FEV1, IC, and hyperinflation.Clinical trial registrationClinicalTrials.gov: NCT02643082.

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“…IND/GLY was superior to SAL/FLU 50/500 in the study of Wedzicha et al [28] enrolling COPD patients with mMRC > 2 and FEV 1 25-60% predicted but not in the studies performed by Vogelmeier et al [33] and Zhong et al [29] including, respectively, COPD patients stages 2-3 according GOLD 2009 and stages 2-3 GOLD 2010 and MRC ≥2. The percentage of patients who reached the MID with GLY/ IND was significantly higher compared to that of the placebo [30], GLY [30,36], SAL/FLU 50/500 [28] or TIO [31]. The use of CAT as secondary outcome measure to assess HRQoL [29] showed no difference in patients treated with IND/GLY 110/50 and SAL/FLU 50/500.…”

Section: Resultsmentioning

confidence: 99%

LABA/LAMA Fixed Dose Combination in Chronic Obstructive Pulmonary Disease: The Impact on Health-Related Quality of Life

et al. 2018

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Background: While fixed dose combinations (FDCs) of long-acting beta 2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are increasingly tested on their efficacy in improving lung function, their effectiveness on Patient Reported Outcomes (PROs) such as Health Related Quality of Life (HRQoL) and Health Status (HS) deserve more attention. Objectives: To review current available evidence about the treatment effect of fixed LABA/LAMA FDCs on HRQoL. Methods: A systematic literature search for randomized controlled trials (RCTs) about the impact of LABA/LAMA FDCs versus placebo, LABA or LAMA or LABA/ICS on HRQoL in Chronic obstructive pulmonary disease (COPD) patients has been performed. Results: Twenty-eight RCTs (n = 32, 165 COPD patients) investigating the impact of fixed LABA/LAMA combinations on HRQoL were included. Using the St George’ s Respiratory Questionnaire, 27 out of 28 trials assessed HRQoL. LABA/LAMA FDCs significantly improved HRQoL versus placebo in 9 out of 11 trials, while change when compared to other LABA or LAMA monocomponents was significantly better in 11 out 24. In 5 out of 6 RCTs having LABA/ICS as comparators, LABA/LAMA FDC had a similar effect and only 1 showed significant improvement in HRQL compared to LABA/ICS FDC. Conclusion: LABA/LAMA FDCs may be helpful in improving HRQoL, but because of the heterogeneity of performed trials, strong conclusions cannot be drawn. Moreover, due to the different molecule properties, treatment schedule, and device characteristics of each FDC, a generalized judgment seems inappropriate. Pragmatic trials powered to detect real-life differences in HRQoL and head-to-head comparison are needed to guide clinical practice in terms of PROs.

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Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD

Abstract: ClinicalTrials.gov; No.: NCT01854645 and No. NCT01854658; URL: www.clinicaltrials.gov.

Cited by 96 publications

References 26 publications

<p>Patient Characteristics and Healthcare Resource Utilization Among Patients with COPD New to LAMA/LABA Fixed-Dose Combination Treatment in US-Based Real-World Practice</p>

<p>Patient Characteristics and Healthcare Resource Utilization Among Patients with COPD New to LAMA/LABA Fixed-Dose Combination Treatment in US-Based Real-World Practice</p>

A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD

LABA/LAMA Fixed Dose Combination in Chronic Obstructive Pulmonary Disease: The Impact on Health-Related Quality of Life

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