Seawater-Rhinitis-Children-Phase III

Efficiency of treatment of allergic rhinitis with seawater by a randomized clinical trial - ETRAMECA-3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000200

Enrollment

240

Registered

2015-09-25

Start date

2010-12-09

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

Procedure and intervention: three clinical evaluations were performed: at baseline, week two (acute phase) and week 12th (preventive phase). Intervention: instructions on nasal lavage and intake by me

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Dry cough (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Productive cough (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Sneezing (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Nasal itching (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Fever (Presence of temperature greater than of 38 ° C, or perception of the mother of the presence of subjective fever, and frequency of fever). Measuring time: at baseline, Week 2, Week 12 Loss of appetite (Perception of the mother about decreased appetite). Measuring time: at baseline, Week 2, Week 12 Sleep quality (Perception of the mother or caregiver frequent awakenings by nasal obstruction or nasal demonstrations that disturb sleep). Measuring time: at baseline, Week 2, Week 12. Nutritional status (Anthropometry test. Parameters of World Health Organization) Measurement time. Measuring time: the baseline, week 2, week 12. Adverse events (Description and intensity). Measuring time: at baseline, week 2, week 12.	—

Measure

Time frame

Dry cough (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Productive cough (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Sneezing (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Nasal itching (qualitative stratified scale, 1-4, where 1 = no symptoms, 4 = maximum ailing. Published in Slapak et al. (2008) Arch Otolaryngol Head Neck Surg, 134 (1): 67-74). Measuring time: at baseline, week 2, week 12. Fever (Presence of temperature greater than of 38 ° C, or perception of the mother of the presence of subjective fever, and frequency of fever). Measuring time: at baseline, Week 2, Week 12 Loss of appetite (Perception of the mother about decreased appetite). Measuring time: at baseline, Week 2, Week 12 Sleep quality (Perception of the mother or caregiver frequent awakenings by nasal obstruction or nasal demonstrations that disturb sleep). Measuring time: at baseline, Week 2, Week 12. Nutritional status (Anthropometry test. Parameters of World Health Organization) Measurement time. Measuring time: the baseline, week 2, week 12. Adverse events (Description and intensity). Measuring time: at baseline, week 2, week 12.

—

Countries

Colombia

Contacts

Public ContactWilmer Soler-Terranova

University of Antioquia

solerw2@gmail.com

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026