The improved efficacy of a fixed-dose combination of fluticasone furoate and levocabastine relative to the individual components in the treatment of allergic rhinitis

2015 ◽  
Vol 45 (8) ◽  
pp. 1346-1355 ◽  
Author(s):  
R. D. Murdoch ◽  
P. Bareille ◽  
D. Ignar ◽  
S. R. Miller ◽  
A. Gupta ◽  
...  
2021 ◽  
Vol 93 (8) ◽  
pp. 986-990
Author(s):  
Alexander V. Emelyanov

Allergic rhinitis (AR) is one the most common allergic diseases affecting from 10 to 40% of the population in different countries, including Russia. AR is a risk factor of bronchial asthma, other upper airway disease and may decrease patient quality of life, their productivity, increase probability of occupational traumatism, depression and anxiety. AR also presents a substantial economic burden. The rationale to use fixed dose combination of intranasal steroids and topical H1 antihistamines includes suboptimal control of symptoms by monotherapy, its complementary pharmacologic activity and the results of clinical trials. This review focused on fixed dose combination of intranasal mometasone furoate and olopataine. Double blind placebo-controlled and open clinical trials have confirmed that this combination decreased severity of nasal and ocular symptoms of seasonal and perennial AR, improved patient quality of life and had a good tolerability. Its efficacy was higher than those of monotherapy. Fast onset of action and sustainable effect on symptoms (during 1 yr) may improve adherence patients to the treatment and control of symptoms of AR.


2016 ◽  
Vol 28 (5) ◽  
pp. 491-498 ◽  
Author(s):  
Dhiraj Abhyankar ◽  
Ashish Shedage ◽  
Milind Gole ◽  
Preeti Raut

The objective of this study was to assess the bioequivalence between a fixed-dose combination of tenofovir disoproxil fumarate/lamivudine/efavirenz 300/300/600 mg and the individual innovator products. A randomized, balanced, open-label, two-sequence, two-treatment, two-period, single dose, crossover study in 48 healthy adults was conducted. Dosing was separated by a washout period of 32 days. Twenty-seven blood samples were collected in each period from pre-dose to 72 h post-dose. The data of 45 subjects were analyzed for pharmacokinetics and safety. Ninety percent CIs of geometric mean ratio on Cmax, AUC0–t, and AUC0-inf for tenofovir and lamivudine and on Cmax and AUC0-72 for efavirenz were within the acceptance criteria (80–125%). For tenofovir disoproxil fumarate, the Tmax, Kel, and t1/2 values for the test and reference products were 1.02 versus 0.91 h, 0.04 versus 0.04/h, 18.67 versus 18.46 h, respectively. For lamivudine, the Tmax, Kel, and t1/2 values were: 1.38 versus 1.30 h, 0.21 versus 0.19/h, 3.44 versus 3.91 h, respectively. For efavirenz, the Tmax values for the test and reference products were 3.71 and 3.65 h, respectively. Both the treatments were well tolerated. Our findings suggest that the tested formulation is bioequivalent to the innovators’ formulations, and both treatments were well tolerated.


Author(s):  
Kiran Bylappa ◽  
Wilma Delphine Silvia C. R.

<p class="abstract"><strong>Background:</strong> <span lang="EN-IN">Allergic rhinitis (AR) is a global health problem. Almost 10%–25% of population worldwide is affected by AR. Seasonal allergic rhinitis (SAR) is caused by an IgE-mediated reaction to seasonal aeroallergens and is fairly easy to identify because of the rapid and reproducible onset and offset of symptoms in association with pollen exposure. SAR can result in hyperresponsiveness to allergens. Treatment of allergic rhinitis is aimed to achieve optimal symptom control and reduce nasal congestion, sneezing and rhinorrhea over the course of the entire day and night. </span></p><p class="abstract"><strong>Methods:</strong> <span lang="EN-IN">Out of total 274 subjects, 92 subjects in the FDC of montelukast 10 mg and levocetrizine 5 mg group, 92 subjects in montelukast 10 mg group and 90 subjects in levocetrizine 5 mg group were enrolled in the study. The total study duration was 16 days. Criteria for evaluation of primary efficacy were mean change in daytime nasal symptoms score from baseline to end of treatment. Mean change in night time symptoms score from baseline to end of treatment. Mean change in daytime eye symptoms score from baseline to end of treatment. Patient's and physician's global evaluation of allergic rhinitis at the end of treatment. Mean change in rhinoconjunctivitis quality-of life score from baseline to end of treatment.  </span></p><p class="abstract"><strong>Results:</strong> <span lang="EN-IN">Primary efficacy endpoint that fixed dose combination (FDC) of montelukast 10 mg and levocetirizine 5 mg was superior to montelukast 10 mg monotherapy or levocetirizine 5mg monotherapy in the treatment of patients with seasonal allergic rhinitis. Other secondary endpoints and global impression results are also supporting the therapeutic benefit of fixed dose combination over monotherapy. </span></p><p class="abstract"><strong>Conclusions:</strong> <span lang="EN-IN">FDC of montelukast 10 mg and levocetirizine 5 mg was superior to montelukast 10 mg monotherapy or levocetirizine 5 mg monotherapy in the treatment of patients with seasonal allergic rhinitis.</span></p>


Pneumologie ◽  
2016 ◽  
Vol 70 (S 01) ◽  
Author(s):  
ED Bateman ◽  
K Chapman ◽  
S Rennard ◽  
L Rekeda ◽  
M Moya ◽  
...  

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