Seawater-Rhinitis-Children-Phase III
Phase 3
- Conditions
- Allergic rhinitis
- Registration Number
- RPCEC00000200
- Lead Sponsor
- Pediatry and Childcare Department of University of Antioquia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
1. Children from 2 to 6 years old.
2. Children belonging to low socioeconomic status from suburban peripheral residency of the city of Medellin.
3. Children previously diagnosed with allergic rhinitis.
Note: This study defines low socioeconomic status based on the official classification of the Town of Medellin.
Exclusion Criteria
1. Children with genetic diseases
2. Chronic degenerative diseases such as cancer
3. Anatomical nose and sinus disorders
4. Nosebleeds daily
5. Severe immune deficiency
6. Corticosteroid medication
7. Children whose parents did not sign informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rhinorrhea (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. It was published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12.
- Secondary Outcome Measures
Name Time Method