scholarly journals Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber)

2018 ◽  
Vol 9 ◽  
pp. 215265671878359 ◽  
Author(s):  
Kazuhiro Hashiguchi ◽  
Kimihiro Okubo ◽  
Yoichi Inoue ◽  
Hirotaka Numaguchi ◽  
Kumi Tanaka ◽  
...  

Background This study evaluated the efficacy of montelukast in reducing seasonal allergic rhinitis symptoms in Japanese children with Japanese cedar (JC) pollinosis induced in an artificial exposure chamber (OHIO Chamber). Methods Pediatric patients aged 10 to 15 years sensitive to JC pollen entered a randomized, double-blind, single-site, crossover study. After confirmation of an allergic response to a JC pollen exposure for 3 hours in the OHIO Chamber during the screening period, subjects received either montelukast 5 mg chewable tablets or placebo for a 7-day treatment period, followed by a 3-hour pollen exposure in the chamber. After a 7-day washout period, subjects crossed over to the other treatment. Subjects were instructed to self-assess their nasal symptoms using 5-point scale for every 30 minutes. The primary end point was the change from baseline (just before entering the exposure chamber for each exposure) in total nasal symptom score (TNSS; the sum of nasal congestion, nasal discharge, and sneezing scores) over 3 hours of pollen exposure. Adverse events (AEs) were evaluated throughout the study. Results A total of 220 subjects (median age, 12 years) received treatment. For TNSS, the between-group difference in the change (95% confidence interval) was −0.01 (−0.11 to 0.10); the change between placebo and montelukast 5 mg was not significant. TNSS in the screening and treatment periods after receiving placebo for 7 days was 1.58 and 1.31, respectively, suggesting a placebo response. On account of high placebo response, a post hoc analysis was conducted. The analysis in a subgroup of subjects who did not show placebo response demonstrated a difference in the efficacy between montelukast and placebo (nominal P < .037). The most common AE was positive urine protein (4.6% with montelukast vs 7.8% with placebo). Conclusions Although montelukast was well tolerated, this study did not demonstrate a treatment difference between active drug and placebo in Japanese children exposed to JC pollen in the OHIO Chamber. Trial Registry: ClinicalTrials.gov, NCT01852812

Author(s):  
Shuaib Kayode Aremu ◽  
Tayo Ibrahim ◽  
Azeez Oyemomi Ibrahim ◽  
Popoola Tomilayo Ajoke

Introduction: Allergic Rhinitis (AR) is a chronic, symptomatic allergic disorder of the nose that is usually caused by IgE-mediated inflammatory response following exposure to an allergen. The allergen could be in the form of dust, pollen, flower, animal dander, mold, cold, food allergens or insect. Clinically, AR occurs when there are recurrent nasal symptoms which are reversible either spontaneously or with medication in the preceding one year. Such symptoms include at least two of the following; excessive sneezing, running nose, nasal itching, nasal discharge, nasal congestion or obstruction. Previous studies have linked AR to be co-existed with another form of allergic disorders including AC, Atopic dermatitis and Allergic Asthma. This study is aimed at assessing the feature of  AR patients with coexistent AC as well as evaluating the effectiveness of the treatments offered to them. Objectives: The study was aimed at finding the correlation between the nasal and eye features in a patient who has co-existing allergic rhinitis and allergic conjunctivitis. Methodology: This was a cross-sectional descriptive study conducted between August 2018 and November 2019 among 38 patients who presented to ENT and Ophthalmology departments of Federal Teaching Hospital Ido-Ekiti, Ekiti State, Southwestern Nigeria and was diagnosed with both allergic rhinitis and allergic conjunctivitis. Relevant data obtained were analyzed using SPSS version 20.  P ≤ 0.05 was taken as significant. Results: The patients’ age range between 8 and 81 years with a median age of 33 years. The majority were less than 45 years (63.2%) with the male to female ratio of almost. Eye pain, itching, and redness account for 97.4% of all the eye features, while the presence of Cobblestone-like papillae is the least and accounted for 5%. Nasal itching (92.1%) was the commonest nasal symptom. Sleep disturbance was found to be the most common among those with eye itching (29.7%). Conclusion: This research was conducted to correlate the features of allergic rhinitis with those of conjunctivitis and common management and preventive measures offered to the patients seen in our clinics. The majority of the patients were less than 45 years with almost equal sex ratio. Eye pain, itching, and redness account for the majority of all the eye features, while the presence of Cobblestone-like papillae is the least eye feature. Nasal itching was the commonest nasal symptom and this was seen in the majority of the patients with eye symptoms.


2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P111-P111
Author(s):  
Anne Marie Frances Salapatek ◽  
Piyush Patel ◽  
Patel Deepen ◽  
Gokul Hiremagalur Gopalan ◽  
Santosh Thomas Varghese

Objectives In a double-blind placebo-controlled study of ragweed-sensitive subjects with seasonal allergic rhinitis (SAR), mometasone furoate nasal spray (MFNS) was evaluated for improvement in nasal congestion, reportedly the most bothersome symptom of SAR. Methods On Day 1, 310 subjects were exposed to ragweed pollen in an environmental exposure chamber (EEC) for 2 hours pre-dose, given MFNS 200 mcg or placebo, and studied for 6 hours post-dose. Acoustic rhinometry (AcR) was used to measure congestion before and after exposure. Subjects (n=155) who received MFNS or placebo for 7 additional days returned to the EEC on Day 8 for 4 additional hours of pollen exposure at 24, 26, and 28 hours post-dose. Results On Day 1, after 2 hours of EEC exposure pre-dose, minimal cross-sectional areas (MCAs) of each nostril measured with AcR decreased significantly for all subjects. At 6 hours post-dose, MFNS significantly reduced congestion (increased nasal patency) vs. baseline (P equal to/less than 0.00001) and placebo (P equal to 0.005). On Day 8, MFNS significantly decreased congestion vs. placebo pre-EEC pollen exposure (P equal to 0.04) and at 2 and 4 hours (P equal to 0.01 and 0.0008, respectively). MFNS protected subjects against nasal congestion throughout EEC pollen exposure on Day 8, while congestion continued to increase in subjects receiving placebo. Conclusions A single treatment of MFNS demonstrated significantly reduced nasal congestion, as assessed by AcR, a sensitive, objective measure of nasal patency. MFNS effectively reduced allergen-induced nasal congestion, even at trough levels.


1994 ◽  
Vol 8 (1) ◽  
pp. 43-48 ◽  
Author(s):  
David P. Skoner ◽  
Barry Asman ◽  
Philip Fireman

Previous studies have documented the changes in airway physiology which accompany natural pollen exposure. This study was designed to determine the effect of chlorpheniramine (8 mg b.i.d.) on seasonal changes in airway physiology and symptoms. Pollen counts, eustachian tube (ET) function, nasal resistance, mucociliary transport, and nasal symptoms were assessed weekly before, during, and after ragweed pollen season in 15 chlorpheniramine-treated and 15 placebo-treated allergic rhinitis (AR) subjects in a double-blind protocol and in 10 untreated control (non-AR) subjects. In placebo-treated AR subjects, the degree of congestion, rhinorrhea, sneezing, ET dysfunction, and nasal obstruction closely tracked pollen counts. However, symptoms, ET obstruction, and nasal obstruction persisted well beyond the temporal peak in pollen counts. There were no changes in mucociliary transport or pulmonary function during pollen exposure. Compared to placebo, chlorpheniramine-treated subjects manifested significantly less (p < .05) seasonal sneezing and rhinorrhea, but similar degrees of nasal congestion, ET dysfunction, and nasal obstruction. Pollen-related changes in nasal physiology and symptoms were not detected in the non-AR subjects. These data document that chlorpheniramine significantly attenuated the seasonal increases in rhinorrhea and sneezing, but did not lessen the concommitant physiologic alterations or the increase in nasal congestion.


2008 ◽  
Vol 8 (2) ◽  
pp. 30-36 ◽  
Author(s):  
K. Hashiguchi ◽  
H. Tang ◽  
T. Fujita ◽  
K. Suematsu ◽  
S. Tsubaki ◽  
...  

2009 ◽  
Vol 10 (4) ◽  
pp. 523-529 ◽  
Author(s):  
Kazuhiro Hashiguchi ◽  
Huaipeng Tang ◽  
Toshio Fujita ◽  
Kiyochika Suematsu ◽  
Minoru Gotoh ◽  
...  

Author(s):  
Flávio Adsuara Cadegiani ◽  
John McCoy ◽  
Carlos Gustavo Wambier ◽  
Andy Goren

BackgroundSARS-CoV-2 entry into type II pneumocytes is depended on the TMPRSS2 proteolytic enzyme. The only known promoter of TMPRSS2 in humans is an androgen response element. As such, androgen sensitivity may be a risk factor for COVID-19. Previously, we have reported a retrospective cohort analysis demonstrating the protective effect of 5-alpha-reductase inhibitors (5ARis) in COVID-19. Men using 5ARis were less likely to be admitted to the ICU than men not taking 5ARis. Additionally, men using 5ARis had drastically reduced frequency of symptoms compared to men not using 5ARis in an outpatient setting. Here we aim to determine if 5ARis will be a beneficial treatment if given after SARS-CoV-2 infection.MethodsA double-blinded, randomized, prospective, investigational study of dutasteride for the treatment of COVID-19 (NCT04446429). Subjects confirmed positive for SARS-CoV-2 were treated in an outpatient setting. Endpoints for the study were remission times for a predetermined set of symptoms: fever or feeling feverish, cough, shortness of breath, sore throat, body pain or muscle pain/ache, fatigue, headache, nasal congestion, nasal discharge (runny nose), nausea or vomiting, diarrhea, loss of appetite, and loss of taste or smell (Ageusia or Anosmia).ResultsA total of 130 SARS-CoV-2 positive men were included in the study, 64 subjects in the dutasteride arm and 66 subjects in the placebo-controlled group. The differences in the average remission times for fatigue and anosmia or ageusia was statistically different between the groups (5.8 versus 10.1 days for fatigue and 7.3 versus 13.4 days for anosmia or ageusia, in dutasteride and placebo groups, respectively), however, the total remission time was significantly reduced for the men given dutasteride; 9.0 days versus 15.6 days in the placebo group (p < 0.001). Excluding loss of taste and smell the average total remission time was 7.3 days in the dutasteride group versus 11.7 in the placebo arm (p < 0.001).ConclusionThe total remission time for men using 5ARis was significantly reduced compared to men not taking 5ARis.


2018 ◽  
Vol 33 (1) ◽  
pp. 12-16
Author(s):  
Minh Cong Vo ◽  
Huu Kien Pham ◽  
Minh Hien Nguyen

Objective: To evaluate the efficacy and safety of posterior nasal neurectomy on the treatment of nasal congestion, rhinorrhea, sneezing, and post-nasal discharge in intractable rhinitis patients. Methods Design:                       Preliminary case series   Setting:                       Tertiary University Medical Center Participants:              Ten (10) patients with intractable rhinitis underwent endoscopic posterior nasal neurectomy in both sides. Symptoms were compared pre- and post-operatively one month and one year after surgery using Visual Analog Scale (VAS) scores. Endoscopic pre- and one-month post-operative Lund-Mackay scores were also compared. Results: All four mean nasal symptom scores were reduced significantly at 1-month follow-up for nasal congestion (1.5 ± 1.08 vs 4.1 ± 0.5687, p = .00001), rhinorrhea (0.7 ± 0.823 vs 3.4 ± 0.966, p = .00001) post-nasal discharge (0.9 ± 0.994 vs 2.4 ± 1.5, p = .03), and sneezing (1.1 ± 0.738 vs 3 ± 0.943, p = .02). Mean endoscopic scores were also reduced significantly at one month, from 12.9 ± 2.55 to 4.2 ± 3, p = 0.0001.In the 6 patients that followed up at 1-year, post-operative mean nasal symptoms were still significantly better for congestion (0.6667 ± 0.8165 vs 4 ± 0.632, p = 0.00001), rhinorrhea (0.6667 ± 0.5164 vs 3.67 ± 1.033, p = .001), post-nasal discharge (0.1667 ± 0.40825 vs 2.17 ± 1.835, p = .033), sneezing (0.5 ± 0.54772 vs 3.17 ± 0.983, p = 0.0001). Mean post-operative VAS nasal scores and endoscopic scores were well associated (Correlation Coefficient -.648, p = .048). Conclusion: Posterior nasal neurectomy could be considered as a safety and effective way to treat intractable rhinitis patients in Vietnam. Keywords: Posterior nasal neurectomy, vasomotor rhinitis, allergic rhinitis, vidian neurectomy


1997 ◽  
Vol 11 (2) ◽  
pp. 109-116 ◽  
Author(s):  
Sara Morris ◽  
Ronald Eccles ◽  
S. Jawad Martez ◽  
Donald K. Riker ◽  
Theodore J. Witek

This was a randomized, double-blind vehicle controlled study aimed at investigating the effects on nasal function of 7 days treatment with the topical decongestant oxymetazoline (0.05% w/v). Fifty healthy volunteers took part in the study and these were randomly allocated to three treatment groups (i) daily oxymetazoline (b.i.d. 150 μl per nostril) (ii) intermittent oxymetazoline, with oxymetazoline being substituted for vehicle at the morning doses on days 1, 3, and 7; and (iii) daily vehicle (b.i.d. 150 μl per nostril). The nasal airway was assessed by measurement of nasal airway resistance (NAR) using posterior rhinomanometry, subjective scaling of nasal patency by means of a visual analogue scale (VAS), and clinical visual examination. On days 1, 2, 3, and 7, NAR and VAS measurements were obtained before the morning dose and up to 6 hours after dosing; clinical visual examinations were also performed before dosing on these days. NAR and VAS measurements were also made following withdrawal of treatment on Days 8 and 9. Nonparametric analysis of the results showed that therapeutic tolerance to oxymetazoline did not develop over the 7-day treatment period, and visual examination of the nasal mucosa failed to find significant evidence of rhinitis. Evidence of rebound nasal congestion was found following 3 days of oxymetazoline treatment, with baseline NAR within the daily and intermittent oxymetazoline groups being significantly greater on Day 3 compared to Day 1 (p < 0.05). However, there was a trend toward increasing baseline NAR in the vehicle group over the course of the study, suggesting that the vehicle may have contributed to the rebound congestion. Following the withdrawal of treatments, only the intermittent oxymetazoline group had significantly higher NAR on Days 8 and 9 compared to Day 1 (p < 0.05). Subjective VAS measurements generally followed trends in NAR.


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