CompletedPhase 4

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

Italy30 participantsStarted 2015-10

Plain-language summary

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)

Who can participate

Age range6 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Symptom score assessment

Timeframe: 28 days

Trial details

NCT IDNCT02729012

SponsorStefania La Grutta, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

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