Glycopyrrolate And Formoterol Fumarate Monotherapy And Combination Metered Dose Inhalers With High Dose Uniformity And Stable Aerosol Properties

Vehring, Reinhard; Hartman, Michael S.; Schultz, Robert K.; Joshi, Vidya; Sommerville, Mark; Cummings, Harris; Smith, Alan M.; Golden, Michael A.; Reisner, Colin; Dwivedi, Sarvajna

doi:10.1164/ajrccm-conference.2010.181.1_meetingabstracts.a4452

Cited by 2 publications

(4 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The particles administered by this device have a mean aerodynamic diameter of 3.5 μm (GP MDI 14.4 μg in monotherapy) [5]. It should be noted that Pearl Therapeutics has recently revised the nomenclature for GP MDI to refer to the active moiety, glycopyrronium, rather than the bromide salt form previously referred to as glycopyrronium bromide (also known as glycopyrrolate).…”

Section: Methodsmentioning

confidence: 99%

“…This was a randomized, double-blind, 4-period, 6-treatment, placebo- and active-controlled, incomplete block, crossover, multicenter study to evaluate the single administration of 4 ascending single doses of GP MDI compared with Placebo MDI and TIO as an active control in study patients with COPD, and was conducted between March, 2009 and September, 2009. The particles administered by this device have a mean aerodynamic diameter of 3.5 μm (GP MDI 14.4 μg in monotherapy) [ 5 ]. It should be noted that Pearl Therapeutics has recently revised the nomenclature for GP MDI to refer to the active moiety, glycopyrronium, rather than the bromide salt form previously referred to as glycopyrronium bromide (also known as glycopyrrolate).…”

Section: Methodsmentioning

confidence: 99%

“…Hollow, porous-particles added to HFA MDIs provide a mechanism for stabilizing suspensions of inhaled drugs, leading to improved physical stability, ability to formulate very low doses, consistent dose-to-dose performance, and high fine-particle fraction (FPF) [ 4 , 5 ]. The large area of the hollow, porous particles allows therapeutic agents to be adsorbed and delivered into the lungs during inhalation.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

et al. 2014

Self Cite

View full text Add to dashboard Cite

BackgroundBronchodilator medications are central to the symptomatic management of chronic obstructive pulmonary disease (COPD). Metered-dose inhalers (MDIs) are the most commonly used devices to deliver treatment to patients with COPD and asthma, comprising approximately 70% of bronchodilator prescriptions. Proprietary porous-particle technology permits the formulation of long-acting muscarinic antagonists, long-acting β2-agonists, and a combination of both in hydrofluoroalkane (HFA) MDIs, providing a solution to formulation challenges inherent to the development of HFA MDIs, which have contributed to the development of dry-powder inhalers.MethodsIn this randomized, double-blind, 4-period, 6-treatment, placebo- and active-controlled, multicenter, crossover study, 4 ascending single doses of a proprietary glycopyrronium (GP) MDI were evaluated compared with Placebo MDI and open-label tiotropium (TIO) in study patients with COPD. Thirty-three study patients were enrolled and received single-dose administration of 4 of the 6 treatments (Placebo MDI, TIO 18 μg, or GP MDI at 14.4, 28.8, 57.6, and 115.2 μg ex-actuator) with an interval of 1 to 3 weeks between doses. The primary efficacy endpoint was peak change in forced expiratory volume in 1 second (FEV1).ResultsAll 4 doses of GP MDI showed statistically superior efficacy compared with Placebo MDI for peak FEV1 (differences of 146 to 248 mL; P < .001), with a clear dose ordering of the response. Statistically significant differences compared with Placebo MDI were noted at almost all doses for the secondary FEV1 parameters (P ≤ .049) except 24-hour trough FEV1 at 28.8 μg. All doses were safe and well tolerated in this study; the most frequently reported adverse event was dry mouth (0–14.3% across doses; 9.5% for Placebo MDI, and 9.1% for TIO).ConclusionsThis study demonstrated superior bronchodilatory efficacy of GP MDI compared with Placebo MDI at all doses tested, and no serious adverse events were reported. This study supports the further evaluation of GP MDI in study patients with COPD. In addition, these findings indicate that the correct dosage of glycopyrronium is no more than 115.2 μg total daily dose, or 57.6 μg twice daily based on comparisons with the active comparator.Trial registrationThis clinical trial was registered on ClinicalTrials.gov, Identifier: NCT00871182.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

et al. 2014

Self Cite

View full text Add to dashboard Cite

show abstract

“…Glycopyrronium/ indacaterol and umeclidinium/vilanterol are both delivered using a dry powder inhaler; tiotropium/olodaterol is delivered using a Soft Mist TM inhaler (Boehringer Ingelheim International, GmbH, Ingelheim am Rhein, Germany); and glycopyrronium/formoterol is delivered using a pressurized metered-dose inhaler. 57,58 Recommendations for device selection in current guidelines are limited. As device suitability depends on several factors (eg, inhalation technique, Table 3 Overview of Inhaler Devices (Adapted from Bonini and Usmani, 2015 11 ; Scichilone et al, 2015;6 59 Dekhuijzen et al, 2016 60 ) coordination, inspiratory flow; Table 3), 11,59,60 an algorithm has been developed to help identify the most suitable inhaler type for a given patient (Figure 2).…”

Section: Other Treatment Considerations: Adopting a Patient-centric Amentioning

confidence: 99%

The Role of Fixed-Dose Dual Bronchodilator Therapy in Treating COPD

Anzueto

Miravitlles

2018

The American Journal of Medicine

View full text Add to dashboard Cite

The incidence of chronic obstructive pulmonary disease (COPD) is rising in the United States, and the disease represents a significant source of morbidity and mortality. Primary care providers face many challenges in COPD diagnosis and treatment, as different clinical phenotypes require personalized treatment approaches. Patient adherence and inhaler technique also contribute to treatment outcomes. Around 48% of primary care providers are unaware of guidelines and recommendations for COPD diagnosis and treatment, which may lead to misdiagnosis or undertreatment of COPD symptoms. Inadequately treated COPD can impair patients' quality of life and ability to perform everyday activities. Long-acting bronchodilator therapy is the cornerstone treatment for patients with COPD; combinations of bronchodilators of different pharmacological classes have shown improved efficacy vs monotherapy. We review the rationale behind fixed-dose dual bronchodilator therapy, evidence for the 4 currently Food and Drug Administration-approved long-acting anticholinergic bronchodilators/long-acting β-agonists fixed combinations, patient suitability for the available inhaler devices, and practical guidance to optimize personalized care for patients with COPD.

show abstract

Glycopyrrolate And Formoterol Fumarate Monotherapy And Combination Metered Dose Inhalers With High Dose Uniformity And Stable Aerosol Properties

Cited by 2 publications

References 1 publication

Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

The Role of Fixed-Dose Dual Bronchodilator Therapy in Treating COPD

Contact Info

Product

Resources

About