Clinical Outcomes with Nasal Saline Irrigation in Children with AR using CARAT and MASK Tools

7 Jun, 22

Introduction

Antihistamines and nasal steroids are used for the symptomatic treatment of allergic rhinitis (AR). Nasal irrigations (NI) are widely used as an add-on treatment for AR as it does not need medical prescription and is safe for long-term use. However, there are lack of clinical studies on their efficacy in children.

Aim

This study assesses the efficacy of a new NI hypertonic solution based on sea water supplemented with algae extracts as add-on treatment for AR.

Methods

Study Design

Open-label, controlled, non-randomized, real-life, prospective quasi-experimental study.

Patient Profile

Children and adolescents aged 6-19 years with symptoms of AR for atleast 6 months

Treatment Strategy

The study cohort were prescribed standard symptomatic treatment.
The active/NI group received a nasal spray of sea-water NI solution supplemented with algae extracts-
- 2 puffs/nostril thrice a day for children <12 years old
- 4 puffs/nostril upto 5 times a day for children >12 years old
Symptom control was evaluated by the control of AR and asthma test (CARAT) questionnaires which had 2 versions-
- CARAT 10 – filled by children aged >12 years directly
- CARAT Kids – filled in by parents and children <12 years old.

Endpoints

CARAT scores
AR symptoms and control assessed by Mobile Airways Sentinel Network (MASK) diary
Total symptom/medication score (TSMS)

Results

A total of 76 patients were assessed in this study; with 53 comprising the active group and 23 as the control group.
The children in the active group had significantly higher improvement based on the CARAT combined analysis (median Z-score change of 1.1 in the active/NI group vs. 0.4 in the control group; p = 0.035).
The analysis of CARAT 10 and CARAT Kids results revealed significantly better symptom control in the active group as shown in table 1.

Table 1. Comparison of CARAT scores

	Median CARAT score on day 30	Median CARAT score on day 1	P values
Children >12 years old
Active group	25.5	21	<0.001
Control group	24	21.5	0.1
Children <12 years old
Active group	2	5	0.002
Control group	2.5	4	0.057

Both the groups had comparable MASK data on allergic symptoms.
The NI group had lower TSMS, with significantly more days with < 20% symptoms than the control group.
The NI group received the prescribed medication for significantly lesser days as compared to controls (26.9% vs. 43.5%; p = 0.005).
The active group required less medication as demonstrated by the Medication Score (16.7 vs 25.7; p=0.006).

Conclusion

Add-on treatment using nasal irrigation with a sea-water solution supplemented with algae extracts resulted in improved symptom control with reduced medication use in children and adolescents with allergic rhinitis.
CARAT questionnaires and MASK/Allergy diary could be useful tools to assess the clinical outcomes in real-life setting.

Clin Transl Allergy 10, 9 (2020). Doi: 10.1186/s13601-020-00313-2.