Trial | NCT02729012  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sodium chloride ...

  • Study Participants

    30
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)
Study Started
Oct 31
2015
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Jan 12
2017
Estimate

Drug hypertonic saline solution (NACL 3%+NAHCO3)

Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)

Other Saline Solution (NACL 0,9%)

Treatment with nebulized Saline Solution (NACL 0,9%)

Case Active Comparator

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

Control Placebo Comparator

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

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.
No Results Posted