Allergic rhinitis (AR) is a common, IgE-mediated inflammatory disorder of the nasal mucosa triggered by allergen exposure, characterized by symptoms such as sneezing, nasal congestion, rhinorrhea, and nasal itching ^[1]. It significantly impacts quality of life, sleep, and work productivity, and is often associated with other allergic conditions like asthma and conjunctivitis ^[2].

Recent epidemiological data suggest that AR affects approximately 10%–30% of the global population, with higher prevalence reported in urban and industrialized regions ^[3]. The ISAAC Phase III study and other contemporary surveys show that AR is increasing, particularly among children and young adults ^[4]. In India, the prevalence is estimated at around 20%–25%, with variation based on geography, pollution levels, and allergen exposure ^[5].

The pathophysiology of AR involves a two-phase allergic response: the early-phase reaction, characterized by mast cell degranulation and histamine release, leading to sneezing and itching; and the late-phase reaction, driven by eosinophils and Th2 lymphocytes, contributing to prolonged nasal obstruction and inflammation ^[6,7]. These mechanisms result in both immediate and sustained symptoms, necessitating a combination of therapies for optimal control.

Management of allergic rhinitis follows a stepwise approach, depending on symptom severity and persistence. First-line treatment includes allergen avoidance, pharmacotherapy, and patient education. Pharmacological options comprise oral antihistamines, intranasal corticosteroids, leukotriene receptor antagonists, and intranasal antihistamines ^[8]. Immunotherapy may be considered in persistent, severe cases ^[9].

Cetirizine, a second-generation oral H₁-antihistamine, is widely used due to its effectiveness, rapid onset, and favourable safety profile. It provides symptomatic relief by inhibiting histamine binding at H₁ receptors, particularly effective for sneezing, itching, and rhinorrhea ^[10]. However, it may have limited efficacy for nasal congestion, a symptom mediated more by other inflammatory pathways.

Azelastine, on the other hand, is a topical intranasal antihistamine with both H₁-receptor antagonist and anti-inflammatory properties. It exhibits rapid onset of action (within 15 minutes) and directly targets the nasal mucosa, making it particularly effective for early-phase symptoms and congestion ^[11]. Recent studies suggest that Azelastine is superior to oral antihistamines in reducing total nasal symptom scores and eosinophilic inflammation, especially in moderate to severe cases ^[12].

This study aims to compare the clinical efficacy of Cetirizine vs. Azelastine nasal spray in patients with allergic rhinitis, focusing on symptom reduction and inflammatory response.

Study Place: The study was conducted in department of ENT, Mahavir Institute of Medical Sciences, Vikarabad, Telangana. it was conducted after taking permission from the institutional ethical committee and after taking inform consent form from the patients.

 Study design: This study was as a prospective, randomized, comparative study was conducted over a period of three months in the outpatient department of ENT at a tertiary care hospital.

 Study Population±

A total of 100 patients between the ages of 18 and 50 years, who were clinically diagnosed with mild to moderate allergic rhinitis, were recruited for the study. The diagnosis was made based on clinical history and symptoms aligned with the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines, which include nasal congestion, sneezing, rhinorrhea, and nasal itching present for at least four weeks.

 Inclusion and Exclusion Criteria

Patients who met the inclusion criteria and gave informed consent were included in the study. Those with structural nasal abnormalities such as deviated nasal septum or nasal polyps, a history of chronic sinusitis or bronchial asthma, current use of steroids or other antihistamines within the last two weeks, or a known allergy to study medications were excluded. Pregnant and lactating women were also excluded.

 Study Groups and Intervention

Participants were randomly allocated into two groups using the sealed envelope method to ensure unbiased selection.

• Group A received an oral antihistamine — Cetirizine 10 mg once daily for 14 days.
• Group B received an intranasal antihistamine — Azelastine nasal spray, administered as one spray in each nostril twice daily for the same duration.

 Assessment and Outcome Measures

All patients underwent a baseline evaluation on Day 0, which included recording the Total Nasal Symptom Score (TNSS). This scoring system is based on four key symptoms: sneezing, nasal congestion, rhinorrhea, and nasal itching. Each symptom was rated on a scale of 0 to 3 (0 = none, 3 = severe), with a maximum total score of 12.

Patients were followed up on Day 7, 14 and 21 On each follow-up visit, the TNSS was recorded again to assess symptom improvement. In addition to the TNSS, patients were asked to report the onset of symptom relief, any adverse effects (such as drowsiness, dry nose, or irritation),

 Data Analysis

The collected data were entered into Microsoft Excel analysis was done by SPSS software. p < 0.05 is stated as statically significant and p > 0.05 stated as non-significant. 

The present study was conducted on 100 allergic rhinitis patients at tertiary care hospital. The study was started after taking permission from institutional ethical committee. the patients were equally divided into two group. Group A patients were treated with cetirizine and group B patients were treated with Azelastine nasal spray. The patients underwent follow for 7, 14 and 21 days.

Table 1: Comparison of Age Group Distribution Between Cetirizine and Azelastine Treatment Groups"

Table 2: Comparison of Gender Distribution Between Cetirizine and Azelastine Groups

Table 3: Comparison of Socioeconomic Class Among Patients Receiving Cetirizine and Azelastine Nasal Sprays"

Table 4: Comparison of Urban and Rural Residence Among Patients Treated with Cetirizine and Azelastine

Table 5: Comparison of Total Nasal Symptom Scores (TNSS) Between Cetirizine and Azelastine Groups at Different Time Points

Table 6Number of Patients Reporting Sneezing in Cetirizine (Group A) and Azelastine (Group B) Over Time.

Table 7: Comparison of Patients Reporting Nasal Obstruction Between Cetirizine (Group A) and Azelastine (Group B) Over Time.

Table 8: Comparison of Patients Reporting Nasal Discharge Between Cetirizine (Group A) and Azelastine (Group B) Over Time.

Table 9: Comparison of Patients Reporting Nasal Itching Between Cetirizine (Group A) and Azelastine (Group B) Over Time

Table 10: Comparison of Patients with Absolute Eosinophil Count >500 Between Cetirizine (Group A) and Azelastine (Group B) Over Time

This comparative study evaluated the efficacy of Cetirizine and Azelastine nasal sprays in patients with allergic rhinitis and analysed the demographic, clinical, and laboratory outcomes over time.

The majority of patients were between the ages of 18–40 years, with 38% in both the 18–30 and 31–40 age groups respectively (Table 1). This age distribution aligns with previous studies by Bousquet et al. (2008) ^[1] , which reported a higher prevalence of allergic rhinitis in young adults due to greater environmental and occupational exposure to allergens. Gender distribution was fairly balanced, with a slight male predominance (58%) overall (Table 2). Similar trends were reported by Gupta et al. (2011) ^[13], who found a male-to-female ratio of approximately 1.3:1 among allergic rhinitis patients.

In terms of socioeconomic status, the majority of patients were from lower middle-class backgrounds (41%), followed by upper middle class (29%) (Table 3). This is consistent with research by Vichyanond et al. (2012) ^[14], which highlighted the higher burden of allergic rhinitis symptoms in middle- and lower-income groups due to poor housing conditions and increased allergen exposure [3].

A predominantly urban residence (65%) was observed among patients (Table 4), likely reflecting increased exposure to pollution and industrial allergens, a trend supported by studies such as that by Ait-Khaled et al. (2008) ^[15], who found allergic rhinitis to be more prevalent in urban settings [4].

Significant improvement in Total Nasal Symptom Score (TNSS) was observed in both groups, but Azelastine showed superior reduction at all follow-up visits. At baseline, mean TNSS was comparable between groups (Cetirizine: 10.7 ± 1.89; Azelastine: 11.14 ± 1.58). By Visit 3, the scores dropped significantly to 1.84 ± 0.84 in Group A and 1.04 ± 0.14 in Group B (Table 5), with a statistically significant difference (p=0.001). These findings align with those of Hampel et al. (2003) ^[11], who reported greater symptom relief with intranasal antihistamines compared to oral agents.

For sneezing, both groups improved over time, but Azelastine-treated patients had a greater reduction, with only 4 patients (8%) reporting sneezing by Visit 3 compared to 11 (22%) in the Cetirizine group (p=0.048) (Table 6). This trend was also reflected in other symptoms: Nasal obstruction showed greater reduction in Azelastine (from 100% to 12%) vs Cetirizine (to 26%) (Table 7).

Nasal discharge reduced significantly in both groups, with Azelastine showing superior outcomes at Visit 3 (10% vs 28%, p=0.031) (Table 8). Nasal itching was present in 84% (Group A) and 90% (Group B) at baseline and reduced more prominently in Group B (to 6%) than Group A (to 18%) by Visit 3 (p=0.067) (Table 9). These results are consistent with the work of Berger et al. (2005) ^[16], who showed that Azelastine has a faster onset of action and broader symptom relief compared to Cetirizine, particularly for nasal itching and sneezing [6].

Absolute eosinophil count (AEC) >500 was initially present in all patients. By Visit 3, only 6 (12%) in the Azelastine group had elevated eosinophil counts, compared to 17 (34%) in the Cetirizine group (p=0.004) (Table 10). This significant eosinophil reduction corroborates findings from a study by Ciprandi et al. (2009) ^[12], which suggested that intranasal antihistamines like Azelastine not only relieve symptoms but also reduce inflammatory markers more effectively.

Both Cetirizine and Azelastine were effective in reducing symptoms of allergic rhinitis over time. However, Azelastine showed greater and faster improvement in total nasal symptom scores, sneezing, nasal obstruction, nasal discharge, nasal itching, and eosinophil counts. These findings suggest that intranasal Azelastine may be more effective than oral Cetirizine in the short-term management of allergic rhinitis.

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