Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study

Stefania La Grutta, MD

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Other: Saline Solution (NACL 0,9%); Drug: hypertonic saline solution (NACL 3%+NAHCO3)

Study type: Interventional

Funder types: Other

Identifiers

NCT02729012

-11/2014

Details and patient eligibility

About

The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology.

The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)

Enrollment: 30 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Clinical history of Allergic Rhinitis (for at least 1 year)
• 6 years old ≤ children age ≤ 14 years old
• Total Symptom Score 5: >5 in the last 4 days before screening. Exclusion Criteria
• Signs of acute infections of upper and lower respiratory tract.
• Metabolic, immunological, systemic diseases
• Respiratory tract deformity
• Systemic/Topical therapies with antibiotics or corticosteroids in the previous 30 days.
• Active smoker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Case

Active Comparator group

Description:

Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)

Treatment:

Drug: hypertonic saline solution (NACL 3%+NAHCO3)

Control

Placebo Comparator group

Description:

Allergic Rhinitis Children treated with saline solution (NACL 0,9%)

Treatment:

Other: Saline Solution (NACL 0,9%)