scholarly journals Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

2020 ◽  
Vol 7 (1) ◽  
pp. 83
Author(s):  
Sagar Panchal ◽  
Saiprasad Patil ◽  
Hanmant Barkate
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Controlled Study ◽  
Global Evaluation ◽  
Double Blind ◽  
Nasal Symptoms

<p class="abstract"><strong>Background:</strong> To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg  FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.</p><p class="abstract"><strong>Methods:</strong> Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score.  </p><p class="abstract"><strong>Results:</strong> At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.</p><p class="abstract"><strong>Conclusions:</strong> Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.</p>

Montelukast Effectively Treats the Nighttime Impact of Seasonal Allergic Rhinitis

2005 ◽  
Vol 19 (6) ◽  
pp. 591-598 ◽  
Author(s):  
Eli O. Meltzer ◽  
George Philip ◽  
Steven F. Weinstein ◽  
Craig F. LaForce ◽  
Marie-Pierre Malice ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Positive Control ◽  
Global Evaluation ◽  
Life Questionnaire ◽  
Double Blind ◽  
Significant Burden

Background Nighttime problems constitute a significant burden on the quality of life of patients with seasonal allergic rhinitis (SAR). The aim of this study was to evaluate the effectiveness of montelukast on nighttime AR symptoms. Methods In seven multicenter, double-blind, parallel-group trials, nighttime problems were assessed as the nighttime symptoms score (NSS), an average of three individual symptom scores: difficulty going to sleep, nighttime awakening, and nasal congestion on awakening (each rated 0 = none to 3 = severe). Patients (aged 15–82 years) were randomized to receive montelukast, 10 mg (n = 1751), placebo (n = 1557), or the positive control loratadine, 10 mg (n = 1616). Results In a combined analysis, changes from baseline (mean ± SE) in NSS were -0.28 ± 0.01, -0.16 ± 0.01, and —0.24 ± 0.01 for the montelukast, placebo, and loratadine groups, respectively. Difference versus placebo in least-squares mean change from baseline were —0.11 (95% confidence interval, -0.14, -0.08; p ≤ 0.001) for montelukast and -0.09 (-0.12, -0.06; p ≤ 0.001) for loratadine. Strong baseline correlations (R > 0.70; p < 0.001) of NSS and two of its individual symptoms with the sleep domain of the validated Rhinoconjunctivitis Quality of Life Questionnaire support the validity and importance of measuring nighttime morbidity in SAR. Furthermore, a clinically important benefit of montelukast on the nighttime impact of SAR was shown using an analysis anchored on the Patient's Global Evaluation. Conclusion These data underscore the importance of nighttime problems in patients with SAR and the need to treat nighttime symptoms. In these studies, montelukast significantly improved the NSS, a clinically relevant and valid measure in patients with SAR.

scholarly journals Combine therapy as a modern approach to treatment of allergic rhinitis

2021 ◽  
Vol 93 (8) ◽  
pp. 986-990
Author(s):  
Alexander V. Emelyanov
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Suboptimal Control ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Double Blind ◽  
Modern Approach ◽  
Dose Combination

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.

scholarly journals Comparison of Budesonide Turbuhaler with Budesonide Aqua in the Treatment of Seasonal Allergic Rhinitis

1998 ◽  
Vol 5 (6) ◽  
pp. 455-460 ◽  
Author(s):  
William H Yang ◽  
Jerry Dolovich ◽  
Michel A Drouin ◽  
Paul Keith ◽  
Jennifer Haddon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Symptom ◽  
Double Blind ◽  
Nasal Irritation ◽  
Eye Symptoms ◽  
Assess Quality ◽  
Substantial Control

OBJECTIVE: To compare the effect of budesonide Turbuhaler 400 µg/day with budesonide aqua 256 µg/day in the treatment of seasonal allergic rhinitis (SAR). Secondarily to ascertain patients' preferences for the two nasal devices and to assess quality of life.DESIGN: Randomized, multicentre, double-blind, double- dummy, parallel groups study.SETTING: Private practices and hospital clinics in Ontario, Quebec and Manitoba.POPULATION: Two hundred and eighty-four out-patients with SAR, who were symptomatic during the ragweed season, volunteered for enrolment (243 randomized).RESULTS: Mean daily nasal symptom scores were significantly reduced with treatment. There were no statistically significant changes from baseline for eye symptoms. Most patients (more than 80%) achieved substantial control of their symptoms with budesonide. The most common nasal and non-nasal adverse events for both groups were epistaxis and headache. Turbuhaler was easier to use and more convenient to carry, had less of an unpleasant taste, and caused less nasal irritation than the aqua spray. More than twice as many patients preferred Turbuhaler to the aqua spray (69% versus 31%). Improvement in quality of life from baseline to clinic visits was statistically significant in both groups.CONCLUSION: Once daily use of 256 mg of budesonide aqua and 400 mg of budesonide Turbuhaler are equally safe and efficacious in the treatment of SAR. Patients preferred the budesonide powder formulation delivered via Turbuhaler two to one over the aqua formulation.

Effects of budesonide and fluticasone propionate in a placebo-controlled study on symptoms and quality of life in seasonal allergic rhinitis

Allergy ◽  
2002 ◽  
Vol 57 (7) ◽  
pp. 586-591 ◽  
Author(s):  
G. Ciprandi ◽  
W. G. Canonica ◽  
M. Grosclaude ◽  
J. Ostinelli ◽  
G. G. Brazzola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Fluticasone Propionate ◽  
Seasonal Allergic Rhinitis ◽  
Controlled Study

scholarly journals Loratadine/Pseudoephedrine for Nasal Symptoms in Seasonal Allergic Rhinitis: A Double-Blind, Placebo-Controlled Study

2000 ◽  
Vol 79 (4) ◽  
pp. 254-267 ◽  
Author(s):  
Edith A. McFadden ◽  
Anil Gungor ◽  
Bernard Ng ◽  
Bülent Mamikoglu ◽  
Rizwan Moinuddin ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Fixed Combination ◽  
Nasal Congestion ◽  
Inferior Turbinate ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Symptoms

In this double-blind, placebo-controlled, crossover, parallel study, we treated 20 adults who had seasonal allergic rhinitis with once-daily fixed-combination loratadine/pseudoephedrine sulfate to observe its effect on relieving symptoms, primarily nasal congestion. Acoustic rhinometry detected a trend toward improvement in nasal patency, although the difference between pre- and post-treatment measures was not statistically significant. Endoscopic inferior turbinate photography documented that treatment led to statistically significant reductions in the amount of nasal edema and nasal secretions. The results of a quality-of-life questionnaire suggested that treatment alleviated nasal and ocular symptoms of rhinoconjunctivitis. An analysis of subjective visual analog scale scores showed a trend toward improvement in most but not all nasal symptoms. We conclude that once-a-day fixed-combination loratadine/pseudoephedrine is effective in relieving nasal congestion in patients with seasonal allergic rhinitis.

Symptom Improvement in Lung Cancer Patients Treated With Erlotinib: Quality of Life Analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21

2006 ◽  
Vol 24 (24) ◽  
pp. 3831-3837 ◽  
Author(s):  
Andrea Bezjak ◽  
Dongsheng Tu ◽  
Lesley Seymour ◽  
Gary Clark ◽  
Aleksandra Trajkovic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Growth Factor Receptor ◽  
Phase Iii ◽  
Controlled Study ◽  
Primary Study ◽  
Symptom Improvement ◽  
Double Blind ◽  
Cancer Symptoms

Purpose This report describes the quality of life (QOL) findings of a randomized placebo controlled study of erlotinib, an epidermal growth factor receptor inhibitor, in patients with non–small-cell lung cancer (NSCLC). Patients and Methods This double-blind phase III trial randomly assigned 731 patients with NSCLC who had progressed after prior chemotherapy to erlotinib 150 mg daily or placebo, with survival as the primary study outcome. QOL was assessed by European Organisation for Research and Treatment of Cancer QLQ-C30 and the lung cancer module QLQ-LC13. The primary end points for QOL analysis were time to deterioration of three common lung cancer symptoms: cough, dyspnea, and pain. Results Survival was significantly longer (hazard ratio, 0.70; P < .0001) in the erlotinib arm. Compliance with QOL was 87% at baseline and more than 70% during treatment. Patients receiving erlotinib had significantly longer median time to deterioration for all three symptoms (4.9 v 3.7 months for cough [P = .04]; 4.7 v 2.9 months for dyspnea [P = .04], and 2.8 v 1.9 months for pain [P = .03]). QOL response analyses showed that 44%, 34%, and 42% of patients receiving erlotinib had improvement in these three symptoms, respectively. This was accompanied by a significant improvement in the physical function (31% erlotinib v 19% placebo, P = .01), and global QOL (35% v 26%, P < .0001). Patients with complete or partial response were more likely to have improvement in the QOL response than patients with stable or progressive disease (P < .01). Conclusion Erlotinib not only improves survival in previously treated patients with NSCLC, but also improves tumor-related symptoms and important aspects of QOL.

Quality of life assessment in patients with moderate to severe allergic rhinitis treated with montelukast and/or intranasal steroids: a randomised, double-blind, placebo-controlled study

2014 ◽  
Vol 128 (3) ◽  
pp. 242-248 ◽  
Author(s):  
B-S Goh ◽  
M I M Ismail ◽  
S Husain
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Placebo Group ◽  
Fluticasone Propionate ◽  
Nasal Spray ◽  
Life Assessment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

AbstractObjective:This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis.Methods:A single-centre, prospective, randomised, double-blind, placebo-controlled study was carried out. Assessments were made using the Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales.Results:A total of 128 patients (aged 13–51 years) were randomly assigned to one of two groups. In the montelukast group, patients were treated with montelukast tablets and fluticasone propionate nasal spray (n = 64). In the placebo group, treatment comprised a placebo and fluticasone propionate. The results showed significant improvements in symptom scores and quality of life scores for both groups after one month and two months of treatment, compared with baseline values; these improvements were significantly greater for the montelukast group compared with the placebo group. The mean number of loratadine tablets taken by each patient during the study period was only 0.73 for the montelukast group compared with 9 for the placebo group.Conclusion:The combination of montelukast tablets and fluticasone propionate nasal spray improved symptom control and overall quality of life for moderate to severe allergic rhinitis patients.

Sign in / Sign up

Export Citation Format

Share Document