Large Volume Low Pressure Nasal Saline Combined with Fluticasone Propionate Effective in Pediatric Acute Rhinosinusitis

27 May, 21

Introduction

Acute bacterial rhinosinusitis (ABR) is one of the complications following upper respiratory tract infection (URTI) in pediatrics. The current treatment for ABR comprises of either systemic therapies like antibiotherapy, corticosteroids and antihistamines or topical therapies like nasal corticosteroids, nasal decongestants, nasal antihistamines and saline irrigation or combination of both therapies. However, the data on topical therapies is limited. There are reports on improved recovery rates with large volume low pressure nasal irrigation solutions.

Aim

This study compares the clinical, radiologic, hematologic and symptomatic parameters of standard therapy comprising antibiotherapy + nasal decongestant and combination of large volume low pressure nasal saline irrigation (LVLP-NSI) and fluticasone propionate (FP) for the treatment of pediatric acute rhinosinusitis.

Methods

Study Design

Randomized-controlled, prospective study.

Patient Profile

Children aged between 5-18 years
URTI not resolving for 10 days or worsening, continuation of all or most of the initial symptoms for 10 days
Purulent discharge from the middle meatus
Abnormal findings in the X-ray Waters view

Treatment Strategy

A total of 105 children were randomized into two groups.
After drop-outs, the final cohort comprised of
Group 1 (n=53) treated with standard therapy (antibiotherapy + nasal decongestant) for 2 weeks
Group 2 (n=52) treated with the LVLP-NSI + FP combination for 3 weeks.
The clinical scores were evaluated at the beginning of the study and then at 7^th, 14^th and 21^st day. Clinical score <8 and >8 indicated mild and severe conditions respectively
The radiologic evaluation was based on the average of right and left maxillary maxillary sinus scores
Peak nasal inspiratory flow (PNIF) measurements were done at the beginning of study and on day 21
Total symptom scores (TSS) were calculated on weekly basis
Complete blood count (CBC), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were compared

Endpoints

Clinical scores
Radiologic evaluations (X-ray Waters view)
PNIF measurements
TSS
Hematologic parameters

Results

The characteristics like age, gender, height and weight of both the groups were similar.
There were no significant differences in the clinical scores among the groups at baseline, day and day 21 (p>0.05 for all). However, group 2 demonstrated significant improvement in the clinical score on day 7 as compared to group 1 (p<0.05)
There were no significant differences in post treatment radiologic evaluations; p=0.072
The difference in the basal PNIF measurement was not significant across the groups.
However, the difference in the post-treatment PNIF values was significant with marked improvement in Group 2 (75.09+5.69 L/min) as compared to Group 1 (61.37+4.08 L/min); p<0.05.
Group 2 showed greater improvement in rhinorrhea, nasal congestion, throat itching and cough symptoms than Group 1.
Post-treatment nasal itching and sneezing was significantly less in Group 2.
The values of hematologic parameters were significantly reduced at the end of the 3rd week in both groups.
There were no significant differences in the pre-and post-treatment values in both the groups (p>0.05 for all 3 parameters)

Conclusion

Large volume low pressure nasal saline irrigation (LVLP NSI) combined with fluticasone propionate (FP) was effective and could be a new line of therapy for the treatment of pediatric acute rhinosinusitis, either by itself or combined with standard therapy.

Int J Pediatr Otorhinolaryngol. 2014 Aug;78(8):1393-9. Doi:10.1016/j.ijporl.2014.06.006.