The prevalence of allergic rhinitis (AR) has increased both globally [1]. Allergic rhinitis symptoms, including rhinorrhea, sneezing attacks, nasal congestion, eye itching, and eye tearing, disturb not only daily life, but also socioeconomics. These symptoms are known to have a negative impact on daily work, school performance, and quality-of-life. Therefore, pollinosis patients are eager to receive appropriate medication against Allergic rhinitis symptoms [2-3].

Wide range of pharmacological substances and their combinations, administered through various routes have been evaluated for their efficacy in allergic rhinitis [4].

Limited numbers of randomized controlled trials were available on efficacy of Nasal Fluticasone and Combination therapy of Montelukast and Levocetirizine in allergic rhinitis patients. Therefore, we conducted the present study to compare the efficacy of intranasal Fluticasone and oral Levocetrizine and Montelukast therapy in treatment of allergic rhinitis at Civil Hospital Jogindernagar of Himachal Pradesh, India.

Aim and Objectives 

The aim of the current study was to compare the efficacy of intranasal Fluticasone and oral Levocetrizine a Montelukast therapy in treatment of allergic rhinitis patients.    

Study Design

The study was a prospective randomized, single blinded, comparative, parallel group study, with two intervention groups.

Study Site

This study was conducted in a Civil Hospital Jogindernagar of Himachal Pradesh, India. 

Study Period

The study was conducted from February 2020 To October 2020.

Study Population

Patients diagnosed with Allergic Rhinitis randomly allocated to the following intervention groups.

Group A

Montelukast tablets 10mg and Levocetrizine Tablet 5 mg in the night time.

Group B

Fluticasone propionate aqueous nasal spray, 200μg one spray in each nostril twice daily.

Inclusion and Exclusion Criteria

Participants of both genders, aged between 15 –45 years were included in the study. Smokers, pregnant women, people with life threatening/chronic persistent severe asthma, chronic respiratory illnesses like bronchiectasis, pulmonary tuberculosis and other obstructive airway disease were excluded from the study. The other exclusion criteria included, recent nasal surgery or anatomic defects of the nose, recent two courses of parenteral steroids within 3 months of screening and presence of any co-morbid systemic illness which may affect the assessment directly or indirectly.

Sample Size

A total of 50 participants were randomly allocated to both the intervention groups, with 25 subjects in each group.

Random Sequence Generation

The participants were randomly allocated to one of the two intervention groups by pre-determined computer generated random number sequence.

Allocation Concealment

Sequentially Numbered, Opaque Sealed Envelopes (SNOSE) method has been used for allocation concealment in the study. The allocated intervention sequence was kept in individual, serially numbered sealed opaque covers and was kept under the custody of an independent statistician. The card board with the intervention name was covered with a silver foil to prevent the visibility. Each time when the participant was recruited the opaque cover was opened and the intervention was communicated to the investigator.

Blinding

The study participant blinding could not be achieved, as the route of administration of two interventions were different. The investigator assessing the treatment outcome and the person analyzing the data were blinded for the intervention.

Ethical Considerations

Informed written consent was sought from all the patients, after thoroughly explaining the study objectives, nature of the intervention, risks and benefits of the intervention to the participants. Complete voluntary nature of participation in the study was explained and no undue pressure or coercion was exerted on the patients. Patients were informed that, they are free to withdraw from the study at any point during the course of the trial. Confidentiality of the study participants was maintained throughout the conduction, analysis and reporting of the study findings.

Study Procedure

After obtaining an informed consent, 50 patients who met the eligibility criteria were randomly assigned in to one of the two intervention groups. 25 patients of Group A received Fluticasone propionate aqueous nasal spray, 200 μg 1 spray in each nostril twice daily. 25 patients of Group B received Montelukast tablets 10 mg and Levocetrizine Tablet 5 mg in the night time. All patients were followed up for 6 weeks. At the end of the 6 weeks the recovery status and other data was collected using the questionnaires and the assessments was subject to statistical analysis.

Statistical Analysis

The data was collected and entered in Microsoft Excel Spreadsheet. Statistical analysis was done using statistical software Epi Info v7.2.2.  Recovery status after 6 weeks was taken as primary outcome variables. The two intervention groups were taken as primary explanatory variable. Descriptive analysis of all the explanatory and outcome parameters was done. All the categorical variables were presented in frequencies and percentages. The numerical variables were presented in Means and Standard deviations. The Socio demographic variables like age and gender, baseline clinical variables like symptoms were compared between the two intervention groups, by appropriate cross tabulations. The association between explanatory and outcome parameters was assessed by calculating mean differences and differences in the proportions. Chi-square test (Fisher’s-exact test) were used appropriately to assess the statistical significance of these associations.  There was no loss to follow up in both groups.

In the present study was conducted in Civil Hospital, Jogindernagar, Himachal Pradesh. Among Group A, maximum patients 11(44%) were in age group of 31-40 years while in Group B maximum patients were in age group of 21-30 years. (p value 0.004) . Among both groups maximum patients were females i.e. in Group A , 14(56%)  patients were in  female while in Group B  17(68%) patients were females.(p value 0.561)(Table 1).

Table 1: Socio-Demiographic Variables of Study Participants

Table 2: Clinical Variables of Study Participants

Table 3: Recovery Status among Study Participants

Among both groups maximum patients  had symptoms of  Sneezing and Headache  i.e. in Group A , 16(64%)  patients had symptoms of  Sneezing & Headache  while in Group B  19 (76%) patients had symptoms of  Sneezing and Headache. (p-value 0.215) .Among Group A, Inferior turbinate hypertrophy was present in 14(56%) patients while in Group B Inferior turbinate hypertrophy was present in 18(72%) patients. (p-value 0.377)(Table 2).

Among Group A, Recovery at 6 weeks was occurred in 9 (36%) patients while in Group B Recovery at 6 weeks was occurred  in 17(68 %) patients (p-value 0.046). So there was statistically significant recovery at 6 weeks occurred in group who were given intranasal fluticasone (Table 3).

In the present study, among Group A , Recovery at 6 weeks was occurred in 9 (36%)  patients while in Group B Recovery at 6 weeks  was occurred  in 17(68 %) patients (p-value 0.046). So there was statistically significant recovery at 6 weeks occurred in group who were given intranasal fluticasone. In corcordence to our findings, in the study done by Apar Jindal et al., [4] the mean reduction in rhinitis symptom scores and improvement in PEFR was higher forpatients who received Fluticasone propionate aqueous nasal spray as compared to patients who received oral Montelukast during all the follow-up periods. 

Another study by Bruce G Martin  et al., [5]  for comparing fluticasone propionate aqueous nasal spray, 200 microg daily, with oral montelukast, 10 mg daily, for the relief of SAR symptoms, Patients with allergic arhinitis were randomized to receive either fluticasone propionate  or montelukast. The primary efficacy measure was the mean change from baseline in daytime total nasal symptom scores (TNSSs) and daytime individual nasal symptom scores [INSSs] assessing nasal congestion, itching, rhinorrhea, and sneezing), averaged across weeks 1 and 2. In their study they found that the mean changes from baseline in daytime TNSSs (p<.001), all daytime INSSs (p<.001), nighttime TNSSs (p<.001), and all nighttime INSSs (p<or = .02) showed significant differences favoring fluticasone propionate over montelukast across 2 weeks of treatment.

Study concluded that there was statistically significant recovery at 6 weeks occurred in patients who were given intranasal fluticasone sparay as compared to patients who were given oral Montelukast t and Levocetrizine tablets.

1. Hashiguchi K. et al. “Efficacy of fluticasone furoate nasal spray and levocetirizine in patients with Japanese cedar pollinosis subjected to an artificial exposure chamber.” Journal of Drug Assessment, vol. 2, no. 1, 2013, pp. 94-105.

2. Meltzer E.O. et al. “Sleep, quality of life, and productivity impact of nasal symptoms in the United States: Findings from the burden of rhinitis in America survey.” Allergy and Asthma Proceedings, vol. 30, no. 3, 2009.

3. Meltzer E.O. et al. “Burden of allergic rhinitis: Results from the pediatric allergies in America survey.” Journal of Allergy and Clinical Immunology, vol. 124, no. 3, 2009, pp. S43-S70.

4. Jindal A. et al. “Comparison of oral montelukast and intranasal fluticasone in patients with asthma and allergic rhinitis.” Journal of Clinical and Diagnostic Research (JCDR), vol. 10, no. 8, 2016, pp. OC06-OC06.

5. Martin B.G. et al. “Comparison of fluticasone propionate aqueous nasal spray and oral montelukast for the treatment of seasonal allergic rhinitis symptoms.” Annals of Allergy, Asthma and Immunology, vol. 96, no. 6, 2006, pp. 851-857.