- Randomized, Double-Blind, Crossover, Clinical-End-Point Pilot Study to Examine the Use of Exhaled Nitric Oxide as a Bioassay for Dose Separation of Inhaled Fluticasone Propionate. [Journal Article]
- JCJ Clin Pharmacol 2017 Nov 28
- This was a randomized, double-blind, crossover, clinical-end-point pilot study examining the hypothesis that inhaled fluticasone propionate decreases exhaled nitric oxide (eNO) concentrations within ...
This was a randomized, double-blind, crossover, clinical-end-point pilot study examining the hypothesis that inhaled fluticasone propionate decreases exhaled nitric oxide (eNO) concentrations within a week of beginning treatment and shows evidence of dose separation across the marketed dose range. Subjects had a ≥6-month history of asthma and screening eNO ≥60 parts per billion. At the start of each treatment period, eNO was ≥55 parts per billion, and forced expiratory volume in 1 second was ≥50% predicted. Subjects attended a clinic visit daily on consecutive mornings during each of 3 1-week treatment periods to measure eNO and receive once-daily doses of 100/50, 250/50, or 500/50 fluticasone propionate/salmeterol combination product (Advair®Diskus). Daily eNO value recorded was the highest of 3 measurements; 1 inhalation of treatment was then administered. Procedures were repeated for 3 treatment cycles, separated by 14-day minimum washouts. A total of 105 subjects were screened; 22 were randomized; and 17 completed all treatments. Mean percentage eNO decrease (standard deviation) from day 1 baseline for each treatment period was 36.6 (±18.7), 45.3 (±16.5), and 54.6 (±12.5) with Advair®100/50, 250/50, and 500/50, respectively. Mean percentage decrease in eNO across each treatment (dose) was modeled using a mixed-model ANOVA. Although the overall treatment was significant (P = .0015), because of the relatively small sample size and within-subject variability, only the 100/50 vs 500/50 (P = .0003) and 250/50 vs 500/50 (P = .047) treatments were significantly different.
- Particle interactions of fluticasone propionate and salmeterol xinafoate detected with single particle aerosol mass spectrometry (SPAMS). [Journal Article]
- IJInt J Pharm 2017 Oct 30; 532(1):218-228
- Particle co-associations between the active pharmaceutical ingredients fluticasone propionate and salmeterol xinafoate were examined in dry powder inhaled (DPI) and metered dose inhaled (MDI) combina...
Particle co-associations between the active pharmaceutical ingredients fluticasone propionate and salmeterol xinafoate were examined in dry powder inhaled (DPI) and metered dose inhaled (MDI) combination products. Single Particle Aerosol Mass Spectrometry was used to investigate the particle interactions in Advair Diskus®(500/50 mcg) and Seretide®(125/25 mcg). A simple rules tree was used to identify each compound, either alone or co-associated at the level of the individual particle, using unique marker peaks in the mass spectra for the identification of each drug. High levels of drug particle co-association (fluticasone-salmeterol) were observed in the aerosols emitted from Advair Diskus®and Seretide®. The majority of the detected salmeterol particles were found to be in co-association with fluticasone in both tested devices. Another significant finding was that rather coarse fluticasone particles (in DPI) and fine salmeterol particles (both MDI and DPI) were forming the particle co-associations.
- Availability and variation of publicly reported prescription drug prices. [Journal Article]
- AJAm J Manag Care 2017; 23(7):444-448
- CONCLUSIONS: Publicly reported information on state prescription drug price websites is often deficient. When prices are reported, there can be significant variation in the prices of prescriptions, which could translate into substantial savings for consumers who pay out-of-pocket for prescription drugs.
- A 6-month safety and efficacy study of fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers in persistent asthma. [Randomized Controlled Trial]
- AAAllergy Asthma Proc 2017 Jul 24; 38(4):264-276
- CONCLUSIONS: The safety and efficacy profiles of Fp MDPI and FS MDPI administered at lower doses were generally comparable with those of Fp HFA and FS DPI, respectively, after 26 weeks of treatment.The ClinicalTrials.gov identifier is NCT02175771.
- Brief Psychotic Episode Caused by Advair Diskus in a Pediatric Patient. [Letter]
- PCPrim Care Companion CNS Disord 2017 May 11; 19(3)
- Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. [Randomized Controlled Trial]
- AJAm J Respir Crit Care Med 2017 May 01; 195(9):1189-1197
- CONCLUSIONS: Our prospective analyses indicate that indacaterol/glycopyrronium provides superior or similar benefits over salmeterol/fluticasone regardless of blood eosinophil levels in patients with COPD. Clinical trial registered with www.clinicaltrials.gov (NCT01782326).
- Asthma control in adult patients treated with a combination of inhaled corticosteroids and long‑acting β2‑agonists: a prospective observational study. [Journal Article]
- PAPol Arch Intern Med 2017 Jan 18; 127(2):100-106
- INTRODUCTION Asthma is a highly prevalent disease that often requires maintenance therapy. Combined inhaled corticosteroid (ICS) and long‑acting β2‑agonist (LABA) inhalers are one of the availabl...
INTRODUCTION Asthma is a highly prevalent disease that often requires maintenance therapy. Combined inhaled corticosteroid (ICS) and long‑acting β2‑agonist (LABA) inhalers are one of the available maintenance treatment options. OBJECTIVES This prospective observational study aimed to assess asthma control in patients treated with ICS/LABA inhalers and to identify factors related to optimal asthma control. PATIENTS AND METHODS The study included 5789 asthmatic patients from Poland, treated with one of the following ICS/LABA inhalers at clinically appropriate doses: beclomethasone/formoterol, fluticasone/ salmeterol, or budesonide/formoterol. The follow‑up lasted 6 months (4 visits in total). The outcomes were physician-reported and patient‑reported asthma control and occurrence of adverse drug reactions. A retrospective logistic regression analysis was performed to identify a potential association between age, obesity, and smoking and the level of disease control. RESULTS A total of 4469 patients completed the study. Throughout the study period, the rate of patient‑reported control of asthma increased from 24.8% to 67.7%, while physician‑reported control increased from 22.6% to 66.4%. The incidence of exacerbations decreased from 23.4% to 1.9%. Less than 0.1% of the patients reported adverse drug reactions. Age, obesity (body mass index ≥30 kg/m2), and smoking were confirmed as factors negatively affecting disease control, with combined ICS/LABA inhalers potentially reducing their effect. CONCLUSION Our results confirm the efficacy and safety of combined ICS/LABA inhalers in a real‑life clinical setting. They also corroborate the finding that obesity, older age, and smoking are risk factors for poor asthma control.
- Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study. [Randomized Controlled Trial]
- IJInt J Chron Obstruct Pulmon Dis 2017; 12:339-349
- CONCLUSIONS: In exacerbating Asian COPD patients, IND/GLY was more effective than SFC.
- Patient characteristics associated with poor inhaler technique among a cohort of patients with COPD. [Multicenter Study]
- RMRespir Med 2017; 123:124-130
- CONCLUSIONS: Poor inhaler technique is common among individuals with COPD, varies between devices, and is associated with race and educational attainment. Tailored educational interventions to teach inhaler technique should be part of the process of initiating and monitoring inhaled therapies.
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- Assessment of the efficacy and safety of fluticasone propionate and salmeterol delivered as a combination dry powder via a capsule-based inhaler versus a multi-dose inhaler in patients with chronic obstructive pulmonary disease. [Randomized Controlled Trial]
- PPPulm Pharmacol Ther 2017; 43:12-19
- CONCLUSIONS: This study demonstrated the clinical non-inferiority of FSC 50/250 μg when administered using Rotacaps/Rotahaler compared with Diskus in patients with COPD. The risk:benefit profile for the two inhalers was comparable.