Total Nasal Symptom Score Scores Research Articles

Endoscopic score: a new method for evaluating different inferior turbinate reduction techniques

Background Nasal airway obstruction is a common complaint faced in otorhinolaryngology, which may significantly impair the patients' quality of life. Inferior turbinate hypertrophy is one of the main causes of chronic nasal obstruction, and different surgical techniques have been described for its reduction. Aim This study compared three different inferior turbinate reduction techniques using a new objective method in addition to a subjective one. Materials and methods A randomized controlled trial was carried out on 45 patients with hypertrophied inferior turbinates, who were randomly divided into three equal groups: group A underwent partial inferior turbinectomy, group B was subjected to inferior turbinate bipolar surface cautery, and group C underwent inferior turbinoplasty. Assessment was done preoperatively and postoperatively at 2 weeks, 1 month, and 3 months using total nasal symptom score (TNSS) and endoscopic score. Results All groups had significant improvements in the TNSS and endoscopic score when compared with baseline data. TNSS mean for all groups declined from 5 to 3 at 3 months after surgery, with P values less than 0.001. Most of the cases of group A (87%), group B (60%), and group C (93%) had an endoscopic score of 0, with nasal airways greater than 6 mm at 3 months after surgery. Conclusion Partial turbinectomy, bipolar cauterization, and turbinoplasty techniques for the inferior turbinate reduction are comparable and effective regarding improvement of the obstructive as well as the nonobstructive nasal symptoms. Endoscopic score is a helpful tool for easy, rapid, and objective assessment of the nasal airway.

The role of oral vitamin D3 supplementation in the treatment of Chronic Rhinosinusitis in adults with Vitamin D deficiency.

Background:Chronic Rhinosinusitis (CRS) is a chronic inflammatory disorder of the mucosal lining of the nose and paranasal sinuses. The ability of Vitamin D (VD3) to augment innate and adaptive immune responses has sparked interest in its immunologic role in the treatment of CRS. In this study, the incidence of vitamin D deficiency in CRS patients was compared to normal population and the beneficial role of Vitamin D supplementation in its treatment was also evaluated.Materials and Methods:It is a retrospective 1-year study of 200 CRS patients with Vitamin D deficiency. The patients were divided into two groups, i.e. 100 patients were given oral Vitamin D supplements and the other group of 100 patients were treated as placebo. Both Vitamin D levels and the Total Nasal Symptom Score (TNSS) were assessed at the start and end of the study period.Results:Of the 200 subjects with CRS, 100 were given oral vitamin D supplementation in the form of Cholecalciferol 60000IU weekly once for 3 months and the other group were treated with placebo. Before the treatment, the average level of serum Vitamin D was 12.31 ng/ml. After 3 months, it increased significantly to 29.71 ng/ml. Similarly, the pretreatment TNSS score was on average 11.92. After 3 months, the scores fell by an average of 10.65 points, a significant statistical difference (P < 0.05).Conclusion:There is a higher prevalence of vitamin D deficiency in CRS patients and that vitamin D supplementation in these patients went a long way in alleviating their symptoms.

The role of budesonide and mometasone furoate on the nasal and sinus symptoms in allergic rhinosinuitis: a randomized study

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Allergic rhinosinuitis is one of the common clinical problems that otorhinolaryngologist faces daily. Sinusitis symptoms like headache, facial pain and eyelid oedema are frequent in patients with allergic rhinitis, which in turn will affect the cognitive function, productivity and quality of life which impair the efficiency of the individual work performance. It may result in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as intranasal steroids play a major role in reducing the symptoms of allergic rhinitis. We plan to compare the efficacy of budesonide nasal spray with mometasone furoate nasal spray in reducing the nasal and sinus symptoms of allergic rhinosinusitis.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; 146 patients of allergic rhinitis with sinusitis symptoms were randomly divided into 2 groups as Group A (n=70) received 256 μg budesonide nasal spray of once daily and Group B (n=76) received 200 μg of mometasone furoate nasal spray daily. The patients were assessed by sino-nasal outcome test (SNOT) score and total nasal symptom score (TNSS) at 2, 6 and 12 weeks interval. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; There is significant reduction in both the groups, in respect to the SNOT and TNSS scores. We also observed significant improvement in the SNOT score in the budesonide group when compared with the mometasone furoate group by 6weeks which continued till the 12 weeks (p=0.001).&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Budesonide nasal spray is more effective than mometasone furoate spray in managing both sinus and nasal symptoms in allergic rhinitis.&lt;/p&gt;

Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

BackgroundAllergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray.MethodsThe study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded.ResultsAfter the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P < 0.05). No significant between-groups differences were observed for changes in TNSS scores [− 0.298 (95% confidence interval −0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P < 0.001) from baseline, though a more obvious reduction was observed for the BMD group (P < 0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05).ConclusionsThese findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS.Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.

Vitamin D: A Modulator of Allergic Rhinitis.

Allergic rhinitis is a topic of concern among clinicians. Despite of being treated in form of oral medicines, nasal drops and sprays several patients come back with complaint of no relief. This necessitates to review and focus on etiology and to find some other treatment regimen. Established relation of serum vitamin D level and various allergic conditions attracts us to use it as a therapeutic agent for allergic rhinitis. It is a case-control observational study recruited 80 subjects with 40 cases and 40 controls. There was drop out of two subjects among cases. Cases were supplement with oral vitamin D (cholecalciferol-1000IU OD) and controls received no treatment. Serum vitamin D level, Total nasal symptom score (TNSS) and total eosinophilic count (TEC) were calculated at 0, 1 and 3months and compared. Pre-treatment average serum vitamin D level of cases was 20.15 + 10.26ng/ml and of control was 27.94 + 13.38ng/ml. The TNSS score of cases was 7.43 + 1.87 and of controls was 5.00 + 1.52. TEC of cases was 546.15 + 113.39 and of controls was 313.33 + 125.08. Post-treatment serum vitamin D level of cases was 38.05 + 14.62 and of controls was 27.43 + 12.76. TNSS of cases was 3.53 + 0.68 and 4.43 + 1.17 in control group, TEC of cases was 68.13 + 38.95 and of controls was 197.03 + 123.36. This study concludes that vitamin D acts as disease modulator in allergic rhinitis In case of allergic rhinitis with vitamin D deficiency its supplementation gives symptomatic relief and also lowers down the values of TNSS and TEC.

Clinical observation of Zhen’ai needling method in Nei Jing (Classic of Internal Medicine) on improving quality of life in patients with allergic rhinitis

To observe the effect of Zhen’ai needling method in Nei Jing (Classic of Internal Medicine) on quality of life in patients with allergic rhinitis (AR). A total of 99 patients with AR who met the inclusion criteria were randomized into a conventional needling group (51 cases) and a Zhen’ai needling group (48 cases). The conventional needling group was treated with acupuncture at Zusanli (ST 36), Hegu (LI 4), Juliao (ST 3), Yingxiang (LI 20), Yintang (GV 29), Shangxing (GV 23) and Baihui (GV 20). The Zhen’ai needling group added acupoints of Zhen’ai needling method {Lieque (LU 7), Shanglianquan [Extra, located at 1 cun above Lianquan (CV 23)] and Tianrong (SI 17)} in addition to points in the conventional needling group. The needles were retained for 30 min. The treatment was performed twice a week. All patients were assessed by total nasal symptom score (TNSS), total ocular symptom score (TOSS) and sino-nasal outcome test-20 (SNOT-20) before and after 15 treatments to evaluate the quality of life. The clinical efficacy was evaluated after 15 treatments. During the treatment, 8 cases dropped out in the conventional needling group and 7 cases in the Zhen’ai needling group. There were no significant differences in TNSS, TOSS and SNOT-20 scores between the two groups before treatment (all P>0.05). After treatment, the total effective rate of the Zhen’ai needling group was 92.7%, versus 88.4% in the conventional needling group. There was no significant difference between the two groups (P>0.05). After treatment, there were no significant differences between the two groups in TNSS and TOSS scores (both P>0.05). The SNOT-20 score of the Zhen’ai needling group was lower than that of the conventional needling group, and the difference was statistically significant (P<0.05). There were statistical differences between the two groups in the scores of cough and nasal reflux (to the throat) of the NOT-20 scale (both P<0.05). Both Zhen’ai needling method and conventional acupuncture are effective in the treatment of AR. Zhen’ai needling method has a better effect than conventional acupuncture in improving cough and nasal reflux (to the throat) in AR patients.

Therapeutic efficacy observation on acupuncture for persistent allergic rhinitis

To observe the clinical effect of acupuncture for persistent allergic rhinitis (PAR). A total of 154 PAR patients were randomized into a treatment group and a control group, 78 cases in the treatment group received acupuncture at meridian points, while 76 cases in the control group received acupuncture at non-meridian points. The treatment was done every other day, 3 times a week for a total 4 weeks. The total nasal symptom score (TNSS), the total non-nasal symptom score (TNNSS) and the rhinoconjunctivitis quality of life questionnaire (RQLQ) were measured before the treatment and after 2 weeks and 4 weeks of treatment, as well as 1 month and 3 months after the treatment to compare the clinical effect between the two groups. After 4 weeks of treatment, the total effective rate in the treatment group was 92.3%, versus 76.3% in the control group, showing a statistically significant difference (P<0.05). Intra-group comparisons of TNSS, TNNSS and RQLQ scores after 4 weeks of treatment showed statistically significant differences (all P<0.05). Between-group comparisons of TNSS, TNNSS and RQLQ score after 4 weeks of treatment and in follow-up visits showed statistically significant differences (all P<0.05). Acupuncture is effective for PAR, and acupuncture at meridian points can produce a better effect than acupuncture at non-meridian points.

비내시경 소견의 알레르기비염 분류 도구와 중증도 평가도구의 상관성 연구

Objectives : We performed a clinical study to investigate characteristics of pattern identifications using nasal endoscopy for allergic rhinitis (AR). Methods : We assessed 32 patients with allergic rhinitis using nasal endoscopy, classifications of allergic rhinitis and it's impact on asthma (ARIA) and total nasal symptom score (TNSS). Results : The watery rhinorrhea score of nasal endoscopy was significantly high in 'persistent and moderate/severe' group (P<0.05). Patients were classified as rhinorrhea group and nasal obstruction group according to nasal endoscopy. TNSS and rhinorrhea score was significantly high in rhinorrhea group (P<0.05). Conclusions : The result may provide that the watery rhinorrhea of nasal endoscopy is useful as 'Cold' and 'Deficiency' pattern identification diagnostic tool.

The Allergic Rhinitis - Clinical Investigator Collaborative (AR-CIC) - optimizing the Nasal Allergen Challenge (NAC) model

Background We sought to optimize the Nasal Allergen Challenge (NAC) model to ensure reliability and repeatability of results by modifying the qualifying criteria and allergen concentration during the challenge. Methods 20 Allergic Rhinitis (AR) participants underwent NAC to determine the concentration at which a Total Nasal Symptom Score (TNSS) of 10/12 OR a Peak Nasal Inspiratory Flow (PNIF) reduction of 50 % was achieved. 4-fold increases in allergen concentration were administered every 15 minutes until qualification criteria were met. The Qualifying Allergen Concentration (QAC) reached was used as a single challenge dose at the subsequent NAC visit. 10 additional ragweed allergic and 4 non-allergic participants were qualified at a TNSS of 8/12 AND a PNIF reduction of 50%. Cumulative Allergen Concentration (CAC) of all incremental doses was used during the subsequent NAC visit. Participants recorded TNSS and PNIF at baseline, 15 minutes, 30 minutes, 1 hour and hourly afterwards up to 12 hours post-challenge during the NAC visit. Results QAC study participants qualifying only based on PNIF reduction had significantly lower TNSS scores than those qualifying on TNSS only or TNSS+PNIF (p<0.01). Participants in both studies’ NAC visit reached peak TNSS at 15 minutes post-challenge followed by a gradual symptom decline, while the “PNIF only” group had significantly lower TNSS compared to others. All 3 groups experienced a decline in peak TNSS following NAC compared to screening, although groups qualifying on TNSS and TNSS+PNIF maintained their PNIF scores. Conclusion The NAC model is well-suited to study AR symptoms. TNSS and PNIF are complementary and must be integrated in the qualifying criteria. Further protocol modifications, such as with multiple allergen challenges during the NAC visit, may produce even more repeatable results. Through optimizing the NAC protocol, the model achieves reproducible results and becomes more reliable; suitable for testing new medications in clinical trials.

To Compare the Safety, Efficacy and Quality of Life in Patients with Allergic Rhinitis Treated with Levocetirizine and Desloratadine

Background: Allergic Rhinitis (AR) is a very common disease that affects almost 10-30% of the world’s population. Second-generation H1 antihistaminics are the preferred drugs for treatment of patients with AR. Levocetirizine and desloratadine are commonly prescribed newer non-sedating second-generation antihistaminics. Various studies show no difference in efficacy and quality of life (QOL) between the two drugs desloratadine and levocetirizine and that the drugs are quiet safe; however, some studies show negative impact on patients’ QOL with these drugs. Studies comparing the two drugs were insufficient in India; hence, this study was designed to evaluate and compare the efficacy, safety and QOL of patients with AR, following treatment with levocetirizine or desloratadine, in the Indian scenario.Methods: This 2-month randomized, prospective study was performed in 60 patients with AR visiting the department of Otorhinolaryngology. Patients were randomized into one of the two treatment groups, and prescribed levocetirizine 5 mg once daily for two weeks or desloratadine 5 mg once daily for two weeks. The outcome measures for the severity of AR symptoms used were Total Nasal Symptom Score (TNSS); and QOL was assessed using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score.Results: Data from 54 patients who completed the study shows that both levocetirizine and desloratadine significantly (p<0.05) improved the AR symptoms and QOL at the end of 2 weeks study period, analyzed using TNSS and RQLQ scores, respectively. However, statistically non-significant differences in analysis of TNSS score between levocetirizine and desloratadine showed that the two drugs may be equally effective in patients with AR, with patients on levocetirizine showing slightly better response. The adverse events were low in patients on levocetirizine and no adverse event was seen with desloratadine. At baseline visit, rhinorrhoea was the most common and severe symptom, whereas nasal itching was the least common and severe symptom.Conclusion: Study findings showed that both levocetirizine and desloratadine were equally effective in patients with AR, however, desloratadine group showed better safety profile. The drugs were safe and well tolerated.

The Effect of Medical Treatment on Voice Quality in Allergic Rhinitis

To evaluate the change in the voice quality of patients with allergic rhinitis (AR) after medical treatment. The study enrolled 69 subjects: 39 with high serum-specific IgE levels to inhalant allergens as the study group and 30 healthy individuals as controls. All patients were evaluated using the total nasal symptom score (TNSS) and voice handicap index-10 (VHI-10) and then underwent an acoustic voice analysis. After 1month of treatment with mometasone furoate nasal spray (two 50-μg puffs in each nostril once daily) and desloratadine (5-mg tablet once daily), the patients repeated the surveys and acoustic voice analysis. The results before and after treatment were compared. The TNSS and VHI-10 scores decreased significantly after treatment (p<0.01). After treatment, the acoustic analysis parameters improved significantly and were similar to the control group, and the maximum phonation time increased significantly (p<0.05). The voice quality of patients with AR is improved with medical treatment.

Olopatadine hydrochloride and rupatadine fumarate in seasonal allergic rhinitis: A comparative study of efficacy and safety

Objective:To compare the efficacy and safety of olopatadine and rupatadine in seasonal allergic rhinitis (SAR).Materials and Methods:A 2-week, single-centered, randomized, open, parallel group comparative clinical study was conducted on patients with SAR. Following inclusion and exclusion criteria, 70 patients were recruited and were randomized to two treatment groups and received the respective drugs for 2 weeks. At follow-up, clinical improvement was assessed in terms of change in total and differential count of leucocytes, serum Immunoglobulin E (IgE) level, Total Nasal Symptom Score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scoring.Results:Both the drugs significantly reduced the differential count (P<0.001) and absolute eosinophil count (P<0.001), but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in serum IgE (P=0.01), TNSS (P<0.001) and RQLQ score (P=0.015) than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group.Conclusions:Olopatadine is a better choice in SAR in comparison to rupatadine due to its better efficacy and safety profile.

Efficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis

Background:Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and reduces quality of life. This study evaluated efficacy and long-term safety of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in children with PAR.Methods:This study comprised a double-blind, 4-week efficacy and safety period followed by a 6-month, open-label safety period. Primary efficacy variable during the double-blind period was mean change in physician-evaluated total nasal symptom score (TNSS) from baseline to day 15. Other efficacy variables during this phase included subject-evaluated TNSS, individual nasal symptoms, and total symptom score (TSS, nasal and non-nasal symptoms, summed). Physician-evaluated improvement in overall condition of PAR was assessed during the open-label period. Adverse events (AEs) were monitored throughout.Results:Subjects aged 3–11 years with PAR (n = 381) were randomized to MFNS 100 µg (n = 190) or placebo (n = 191) daily for 4 weeks; 357 subjects continued into the open-label period, receiving MFNS only. Between baseline and day 15, significantly greater mean changes were seen with MFNS-treated patients than placebo in physician-evaluated TNSS (−2.8, −39%, vs. −2.2, −32%; p = 0.02). Statistically significant improvements in MFNS versus placebo were reported for subject-evaluated TNSS, TSS, and individual nasal symptom scores (p ≤ 0.03 for all).Improvement continued through the open-label period. Subjects treated with MFNS in both periods experienced a 45% further reduction in TSS in this study phase, while those who switched from placebo to MFNS saw a further 49% decrease. MFNS was well-tolerated in both periods. The most frequently reported treatment-related AEs during the double-blind period for MFNS and placebo, respectively, were epistaxis, seven (4%) and nine (5%); sneezing, five (3%) and seven (4%); headache, six (3%) and five (3%). During the open-label period, the AEs reported most often were epistaxis 37 (10%), headache nine (3%), and rhinitis 12 (3%).Limitations:Studies in children present unique challenges because subjects are too young to grasp subjective concepts such as symptom severity, especially as rated on a numbered scale. In addition, the 6-month extension of the placebo-controlled phase used a single agent. It is also possible that subjects’ symptoms could have abated independent of mometasone furoate treatment.Conclusion:MFNS 100 µg/day effectively reduces TNSS, TSS (including ocular symptoms), and individual symptoms associated with PAR and is well-tolerated for up to 6 months in children aged 3–11 years with a safety profile similar to placebo.

Comprehensive report of the efficacy, safety, quality of life, and work impact of Olopatadine 0.6% and Olopatadine 0.4% treatment in patients with seasonal allergic rhinitis

Seasonal allergic rhinitis (SAR) treatment should reduce symptoms and help patients resume normal function. This study was performed to determine the effect of olopatadine (Olo) nasal spray on symptoms, quality of life (QoL), work, and activities of SAR patients. A pooled analysis was conducted of two Institutional Review Board-approved, randomized, double-blind clinical trials that compared 2-week treatment with Olo 0.6% and Olo 0.4% to placebo. Symptoms were assessed with the Total Nasal Symptom Score (TNSS) from daily diaries. Health outcomes were measured by the Work Productivity and Activity Impairment Questionnaire-Allergy Specific (WPAI-AS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The studies included 1240 SAR patients with a mean age of 37 years; 64% were women. TNSS and RQLQ improvements were significantly different from placebo: TNSS, Olo 0.6% (p < 0.0001) and Olo 0.4% (p < 0.0037); RQLQ, Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). WPAI-AS improvements also were significant for overall work impact and activity impairment in the Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). Correlations between Olo 0.6% TNSS scores and work impact were r = 0.45 (p < 0.0001); activities, r = 0.55 (p < 0.0001); and RQLQ score, r = 0.61 (p < 0.0001), indicating that symptom reduction with Olo therapy was associated with improvements in function and QoL. Adverse events were nonserious and infrequent in all treatment groups. The most frequent adverse events were unpleasant taste and headache. This analysis indicates that Olo is a safe and effective intranasal treatment and is associated with significant improvement in QoL and ability to perform work and conduct usual activities of SAR patients.

Impact of azelastine nasal spray on symptoms and quality of life compared with cetirizine oral tablets in patients with seasonal allergic rhinitis

In fall 2004, the first Azelastine Cetirizine Trial demonstrated statistically significant improvements in the total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores with the use of azelastine nasal spray vs oral cetirizine in patients with seasonal allergic rhinitis (SAR). To compare the effects of azelastine nasal spray vs cetirizine on the TNSS and RQLQ scores in patients with SAR. This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to-severe SAR to azelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily. The primary efficacy variable was the 12-hour reflective TNSS (rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were individual symptom scores and the RQLQ score. Azelastine nasal spray and cetirizine significantly improved the TNSS and individual symptoms compared with baseline (P < .001). The TNSS improved by a mean of 4.6 (23.9%) with azelastine nasal spray compared with 3.9 (19.6%) with cetirizine. Significant differences favoring azelastine nasal spray were seen for the individual symptoms of sneezing and nasal congestion. Improvements in the RQLQ overall (P = .002) and individual domain (P < or = .02) scores were greater with azelastine nasal spray. Both treatments were well tolerated. Azelastine nasal spray and cetirizine effectively treated nasal symptoms in patients with SAR. Improvements in the TNSS and individual symptoms favored azelastine over cetirizine, with significant differences for nasal congestion and sneezing. Azelastine nasal spray significantly improved the RQLQ overall and domain scores compared with cetirizine.

Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis

Azelastine nasal spray and oral cetirizine are selective histamine H(1)-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR). The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR. This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR. After a 1-week placebo lead-in period, patients were randomized to receive azelastine nasal spray 2 sprays per nostril twice daily plus placebo tablets or cetirizine 10-mg tablets once daily plus a placebo saline nasal spray for the 2-week double-blind treatment period. The primary efficacy variables were (1) change from baseline to day 14 in the 12-hour reflective total nasal symptom score (TNSS), which combines scores for rhinorrhea, sneezing, itchy nose, and nasal congestion, and (2) onset of action, based on the instantaneous TNSS over 4 hours after the first dose of study drug. During the double-blind treatment period, patients recorded their symptom scores on diary cards twice daily (morning and evening). Patients aged > or =18 years also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and on day 14. Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline (P < 0.001). The overall change in TNSS was significantly greater with azelastine nasal spray compared with cetirizine (29.3% vs 23.0% improvement, respectively; P = 0.015). In terms of onset of action, azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline (P < 0.001); the overall RQLQ score was significantly improved with azelastine nasal spray compared with cetirizine (P = 0.049). Both treatments were well tolerated. In this 2-week study in patients with moderate to severe SAR, azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine.