scholarly journals Medium-Dose Indacaterol/Glycopyrronium/Mometasone Furoate Fixed-Dose Combination Improves Lung Function Compared with High-Dose Indacaterol/Mometasone Furoate and Salmeterol/Fluticasone and Reduces Exacerbation Rates Versus High-Dose Salmeterol/Fluticasone in Moderate-to-Severe Asthma: The IRIDIUM Study

2020 ◽  
Author(s):  
A. Papi ◽  
M. Humbert ◽  
K. Kostikas ◽  
C. Domingo ◽  
J.F. Maspero ◽  
...  
Keyword(s):  
Lung Function ◽  
Severe Asthma ◽  
Mometasone Furoate ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
High Dose ◽  
Dose Combination ◽  
Medium Dose

scholarly journals Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Satoru Inoue ◽  
Soniya Vaidya ◽  
Hanns-Christian Tillmann ◽  
Yohei Sakita ◽  
Surendra Machineni ◽  
...  
Keyword(s):  
Geometric Mean ◽  
Mometasone Furoate ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
High Dose ◽  
Open Label ◽  
Post Dose ◽  
Glycopyrronium Bromide ◽  
Dose Combination ◽  
Medium Dose

Abstract Background A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler® device (IND/GLY/MF) is being developed for treatment of asthma. This study compared steady-state pharmacokinetics of IND, GLY and MF between Japanese and Caucasian male subjects after multiple inhalations of IND/GLY/MF o.d. Methods This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14. Results In total, 16 Japanese (median age 31 years [range 20–40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21–43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for Cmax for IND, GLY and MF at the high ICS dose on Day 14 were 1.31 [1.13, 1.51] 1.38 [1.13, 1.69] and 1.07 [0.969, 1.18], respectively. Geometric mean ratios (Japanese/Caucasian) [90% CI] for AUC0–24h on Day 14 for IND, GLY and MF at the high ICS dose were 1.17 [1.01, 1.35], 1.05 [0.920, 1.20] and 1.15 [1.05, 1.27] respectively. Similar trends were noted for all components for the medium ICS dose treatment. IND/GLY/MF was safe and well tolerated; no AEs suspected to be study drug-related were observed. Conclusion Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups. Trial registration Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.

Antihyperlipidemic and Antiobesity potential of Aquilaria agallocha & Borago officinalis in Fixed Dose Combination; A Contingent Probe with Atorvastatin & Orlistat

2021 ◽  
Vol 17 ◽  
Author(s):  
Rohima Oraon ◽  
Tarique Mahmood ◽  
Arshiya Shamim ◽  
Farogh Ahsan ◽  
Mohammad Shariq ◽  
...  
Keyword(s):  
Weight Ratio ◽  
Good Control ◽  
Fixed Dose Combination ◽  
Atherogenic Index ◽  
Heart Weight ◽  
Fixed Dose ◽  
Control Group ◽  
High Dose ◽  
Borago Officinalis ◽  
Dose Combination

: Hyperlipidemia and Obesity have been an alarmingly rising health disorders for the past few decades worldwide. They eventually pave way for cardiovascular and other metabolic health risks that are manifested with elevated blood lipid levels. Atherosclerosis, Coronary artery disease and Cerebrovascular diseases, are some major complications of hyperlipidemia. The current clinically available drugs like, Statins & HMG-Co-A inhibitors have a good control on hyperlipidemia but present many insalubrious effects like myopathy & hepatotoxicity that questions their risk-benefit ratio. The current study was designed to develop a fixed-dose combination (FDC) of extracts of Aquilaria agallocha and Borago officinalis, to delve into therapeutic resources that have synergistic benefits and could overpower the adverse effects of modern therapy. These plants are well reported for cardioprotective, immunomodulatory and hepatoprotective potentials. The FDC developed with these plants was examined for its antihyperlipidemic and antiobesity potential in HFD fed animal model (Vijaya et al) for Hyperlipidemia. The extracts from leaves of Borago officinalis and Aquilaria agallocha were administered perorally for 28 days in a fixed dose combination (FDC) in HFD fed rats. The physical and the biochemical parameters; viz, the gross examination of liver, heart, heart weight/body weight ratio, atherogenic index, various hepatic & cardiac biomarker enzymes and serum lipid markers were scrutinized. The result of the study suggested that both the low and high dose of the FDC of Aquilaria agallocha & Borago officinalis has significant Anti-Hyperlipidemic and Anti-Obesity potential against High-fat diet-induced Hyperlipidemia and Obesity when compared to disease control group (at p<0.01 & p<0.001) and their effects were at par with clinically established drugs Atorvastatin & Orlistat.

scholarly journals Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia

2018 ◽  
Vol 9 (1) ◽  
pp. 32-40 ◽  
Author(s):  
Manfaluthy Hakim ◽  
Nani Kurniani ◽  
Rizaldy Taslim Pinzon ◽  
Dodik Tugasworo ◽  
Mudjiani Basuki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Vitamin B1 ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
High Dose ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Dose Combination

Background: Peripheral neuropathy is a common condition which can have a significant impact on quality of life. It occurs as a component of several common and rare diseases or can be idiopathic and can present with various symptoms.Aims and Objectives: This study is aimed at evaluating the effectiveness and safety of the fixed dose combination of vitamin B1, B6 and B12in mild to moderate peripheral neuropathy of various etiologies in the Indonesian population.Materials and Methods: This was a prospective, open label, multi-center, single arm observational study (Indonesian Clinical Trial Registry No: INA-KPA0DYA). A total of 411 subjects with mild to moderate peripheral neuropathy of various etiologies, who met the eligibility criteria, were included in the study. A subject was considered to have “completed” the study if the study procedures, up to Visit 3 (one month of treatment) were accomplished. Procedural results and 12-week clinical outcomes are reported.Results: Treatment with combination of vitamin B1, B6 and B12 in subjects with symptoms of PN showed significant improvement in overall Total Symptom Score (TSS), within 14 days. The treatment also successfully reduced individual components of TSS from baseline to Visit 5. A significant percentage reduction was also observed for all the Visual Analogue Scale (VAS) parameters at the end of 12 weeks, while the Quality of Life (QoL) scores increased from baseline to the end of treatment.Conclusions: The fixed dose combination of vitamin B1, B6 and B12 was effective and welltolerated in subjects with mild to moderate peripheral neuropathy, of various etiologies.Asian Journal of Medical Sciences Vol.9(1) 2018 32-40

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