scholarly journals Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease

2015 ◽  
pp. 803 ◽  
Author(s):  
Yukio Makihara ◽  
Kazuhisa Asai ◽  
Malcolm Johnson ◽  
Akihiro Kobayashi
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Fluticasone Propionate ◽  
Combination Therapy ◽  
Pulmonary Disease ◽  
Japanese Patients ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Anti Inflammatory

A generic fluticasone propionate and salmeterol dry powder inhaler: Evidence of usability, function, and robustness

2021 ◽  
Vol 42 (1) ◽  
pp. 30-35 ◽  
Author(s):  
Donald P. Tashkin ◽  
Arkady Koltun ◽  
Róisín Wallace
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Fluticasone Propionate ◽  
Healthy Volunteers ◽  
Pulmonary Disease ◽  
Dry Powder Inhaler ◽  
Chemical Degradation ◽  
Chronic Obstructive ◽  
Dry Powder ◽  
Obstructive Pulmonary Disease ◽  
Flow Rates

Background: A generic combination of fluticasone propionate and salmeterol xinafoate inhalation powder in a premetered, multidose, nonreusable inhaler was recently approved. Objective: To assess the performance of the generic device. Methods: Findings from three studies with regard to device usability, function, and robustness were reviewed. Results: In a study to assess device function in patients and healthy volunteers, the generic device was successfully used by patients with asthma and chronic obstructive pulmonary disease who were either dry powder inhaler users or dry powder inhaler‐naive, even though they were not trained beyond being provided the instructions for use. In a study to measure inhaled flow rates generated by patients and healthy volunteers, the generic device consistently simulated the delivery of a full dose of drug, even to patients with severe respiratory disease and reduced inspiratory flow rates. Although the generic device had a slightly higher airflow resistance, this study demonstrated that this difference did not result in any clinically meaningful differences in terms of drug delivery. Pressure drop, a key parameter that drives the fluidization and aerosolization of the powder dose, was found to be comparable between the devices. In an open-label study, the generic device met all U.S. Food and Drug Administration specifications for device robustness after 21.5 days of twice-daily dosing via oral inhalation among 111 participants with asthma or chronic obstructive pulmonary disease. All inhalers tested demonstrated conformity with a pharmacopeia with respect to key quality parameters (assay, delivered dose uniformity, aerodynamic size distribution). There was no evidence of chemical degradation of the active ingredients, nor of microbial or water ingress into the powder, as a result of inhaler use.

Bronchodilator and anti-inflammatory therapy of chronic obstructive pulmonary disease from the position of interchangeability

2021 ◽  
Vol 31 (4) ◽  
pp. 518-529
Author(s):  
E. A. Orlova ◽  
I. P. Dorfman ◽  
M. A. Orlov ◽  
A. K. Andreeva ◽  
M. A. Abdullaev
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Generic Drugs ◽  
The State ◽  
Chronic Obstructive ◽  
Anticholinergic Drugs ◽  
Adherence To Treatment ◽  
Obstructive Pulmonary Disease ◽  
State Register ◽  
Anti Inflammatory

The choice of drugs used to treat patients with chronic obstructive pulmonary disease (COPD) (inhaled β-agonists, M-anticholinergic drugs, inhaled corticosteroids (ICS)) in view of their interchangeability is reviewed in this article. This aspect is especially important for clinicians when choosing an effective and safe treatment for COPD and for increasing patient adherence to treatment.The aim of this study was to assess the ratio of the number of reference (original), interchangeable, and generic drugs used in COPD.Methods. In accordance with the Russian clinical guidelines 2018 and GOLD 2019, modern drugs for the treatment of COPD with bronchodilator and anti-inflammatory activity were selected. All trade names of the corresponding drugs for each international non-proprietary name (INN) In the State Register of Medicines website were considered. The information on the availability of reference (original) drugs and the corresponding interchangeable products, as well as their presence in the List of vital and essential drugs was analyzed.Results. A large number of generic prodcuts are registered in the State Register of Medicines, and only a few of them are interchangeable with the corresponding reference (original) drug.Conclusion. The analysis will help widen the doctors’ choice of interchangeable drugs in treatment of COPD with an equivalent effect and safety of reference drugs, as well as to increase the patients’ adherence to treatment.

Sign in / Sign up

Export Citation Format

Share Document