Allergic rhinitis (AR) is a prevalent chronic inflammatory condition of the nasal mucosa, triggered by allergen exposure, leading to symptoms such as nasal congestion, rhinorrhea, sneezing, and itching (1). It affects approximately 10–30% of the global population, significantly impacting the quality of life and productivity (2). AR is primarily mediated by an IgE-driven immune response, leading to the release of inflammatory mediators such as histamine, prostaglandins, and leukotrienes, which contribute to mucosal edema and excessive nasal secretions (3).

Topical nasal corticosteroids (TNS) are the first-line pharmacological treatment for AR due to their potent anti-inflammatory properties, effectively reducing nasal congestion, sneezing, and rhinorrhea (4). Commonly prescribed TNS include Fluticasone Propionate, Mometasone Furoate, and Budesonide, each differing in potency, bioavailability, and systemic absorption (5). Despite their widespread use, comparative studies analyzing their relative efficacy and safety profiles remain limited. Fluticasone Propionate is known for its strong anti-inflammatory effect with minimal systemic absorption, making it a preferred choice for long-term use (6). Mometasone Furoate, with a similar safety profile, has demonstrated high efficacy in symptom relief (7), while Budesonide is frequently used due to its favourable safety record and proven efficacy in mild to moderate cases (8).

Although previous studies have established the effectiveness of TNS, there is limited head-to-head comparison of these agents in a randomized clinical trial setting. This study aims to compare the efficacy and safety of Fluticasone Propionate, Mometasone Furoate, and Budesonide in managing allergic rhinitis, providing evidence-based recommendations for optimal treatment selection.

Study Design and Participants

This randomized clinical trial was conducted at a tertiary care hospital over a period of 12 weeks. A total of 120 participants diagnosed with allergic rhinitis (AR) based on clinical symptoms and diagnostic criteria were enrolled. Inclusion criteria included patients aged 18–60 years with moderate to severe AR symptoms persisting for at least one year. Patients with a history of nasal polyps, recent nasal surgery, respiratory infections, or systemic corticosteroid use within the past four weeks were excluded.

Randomization and Intervention

Participants were randomly allocated into three groups (n = 40 each) using a computer-generated randomization sequence. The intervention groups received one of the following topical nasal steroids:

• Group A: Fluticasone Propionate (200 mcg/day)
• Group B: Mometasone Furoate (200 mcg/day)
• Group C: Budesonide (256 mcg/day)

Patients were instructed to administer the nasal spray once daily for 12 weeks. Adherence to treatment was monitored through self-reported diaries and follow-up visits.

Outcome Measures

The primary outcome was the change in Total Nasal Symptom Score (TNSS), which includes nasal congestion, rhinorrhoea, sneezing, and nasal itching, each graded on a 4-point scale (0–3). The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used as a secondary outcome measure to assess the impact of AR on daily activities.

Assessment and Follow-up

Patients were assessed at baseline, week 4, week 8, and week 12. Symptom severity and quality of life scores were recorded at each visit. Adverse events such as nasal irritation, epistaxis, and headache were documented.

Statistical Analysis

Data analysis was performed using SPSS version 26.0. Continuous variables were presented as mean ± standard deviation (SD), and categorical variables as percentages. The paired t-test was used for within-group comparisons, while one-way ANOVA was applied for between-group differences. A p-value < 0.05 was considered statistically significant

Baseline Characteristics

A total of 120 participants were enrolled and randomized into three groups. The baseline characteristics, including age, gender distribution, duration of allergic rhinitis, and baseline Total Nasal Symptom Score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, were comparable among the groups (Table 1). No significant differences were observed in baseline parameters (p > 0.05), ensuring homogeneity across groups.

Changes in Symptom Severity (TNSS) Over 12 Weeks

All three treatment groups demonstrated a significant reduction in TNSS scores over the 12-week period (p < 0.05). Fluticasone Propionate showed the greatest improvement, reducing from a baseline score of 8.2 to 2.3 by week 12. Mometasone Furoate exhibited a decrease from 8.1 to 2.7, while Budesonide showed a reduction from 8.0 to 3.1 (Table 2).

Quality of Life (RQLQ) Improvements

Significant improvements in RQLQ scores were observed across all groups, with Fluticasone Propionate showing the greatest reduction (from 5.4 at baseline to 0.6 at week 12), followed by Mometasone Furoate (from 5.5 to 1.2) and Budesonide (from 5.3 to 1.5) (Table 3). The differences between groups were statistically significant at weeks 8 and 12 (p < 0.05), with Fluticasone demonstrating the most substantial improvement.

Adverse Effects

Mild adverse effects such as nasal irritation and occasional epistaxis were reported in all groups, but there was no significant difference in the incidence rates among the three treatment arms. No severe adverse events were recorded.

These findings suggest that all three topical nasal steroids effectively reduce AR symptoms and improve the quality of life, with Fluticasone Propionate showing slightly superior efficacy. ​​

Table 1: Baseline Characteristics of Study Participants

Table 2: Changes in Symptom Severity (TNSS) Over 12 Weeks

Table 3: Changes in Quality of Life (RQLQ) Scores Over 12 Weeks

This randomized clinical trial assessed the efficacy and safety of three intranasal corticosteroids (INCSs)—Fluticasone Propionate, Mometasone Furoate, and Budesonide—in managing allergic rhinitis (AR). Our findings indicate that all three INCSs significantly reduced Total Nasal Symptom Scores (TNSS) and improved Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores over the 12-week study period, with Fluticasone Propionate demonstrating a slightly superior efficacy (1,2,3).

The efficacy of Fluticasone Propionate observed in our study aligns with previous research. A systematic review and network meta-analysis concluded that Mometasone Furoate and Fluticasone Furoate were among the most effective INCSs for improving TNSS in seasonal AR, while Budesonide ranked highest in perennial AR. This suggests that while Fluticasone Propionate is effective, other INCSs may offer comparable benefits depending on the AR subtype (4-7).

In terms of safety, all three INCSs were well-tolerated, with minimal adverse effects reported. This is consistent with existing literature indicating that INCSs have a favourable safety profile when used at recommended doses (8-11). However, it is important to consider the pharmacokinetic properties of each INCS, as differences in systemic absorption and bioavailability can influence safety profiles. For instance, Mometasone Furoate and Fluticasone Propionate exhibit negligible systemic absorption, which may reduce the risk of systemic side effects (12-15).

Our study's findings are also supported by a comparative review that found no significant differences in efficacy among various INCSs, including Fluticasone Propionate, Mometasone Furoate, and Budesonide. This suggests that the choice of INCS can be tailored to individual patient preferences, tolerability, and cost considerations.

It is noteworthy that while our study found Fluticasone Propionate to have a slight edge in efficacy, other studies have reported varying results. For example, a study comparing Budesonide and Fluticasone Propionate found that Budesonide decreased combined nasal symptoms to a greater extent than Fluticasone. These discrepancies highlight the importance of individualized treatment approaches in AR management.

In conclusion, our study reinforces the efficacy and safety of Fluticasone Propionate, Mometasone Furoate, and Budesonide in managing allergic rhinitis. While Fluticasone Propionate demonstrated a slight advantage in efficacy, the choice of INCS should be individualized, considering factors such as patient preference, tolerability, and specific AR characteristics.

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