Seawater-Rhinitis-Children-Phase III

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

AMARIN-3

Scientific title:

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

Acronym of Scientific Title:

ETRAMECA-3

Secondary indentifying numbers:

2472

Issuing authority of the secondary identifying numbers:

Medical Research Institute (IIM) of University of Antioquia

Source(s) of monetary or material support:

University of Antioquia (Colombia) Aquamaris Foundation (Badalona, Spain)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria

Midle name:

de la Luz

Last name:

Valencia-Chavez

Medical Specialty :

Paediatry Pneumology, M.D.

Affiliation:

Clinica Las Vegas

Postal address:

Calle 2 Sur Num. 46-55, consultorio 215

City:

Medellin

Country:

Colombia

Zip Code:

050022

Telephone:

+57-42660097

+57-3002696563

Email address:

mlvalenc@hotmail.com

solerw2@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Antioquia, Paediatric and Child Care Department of University of Antioquia, Agusto Quevedo-Velez MD, Paediatry Epidemiology Clinics.

Research ethics committees:

Bioethics Committee of the Medicine Faculty of University of Antioquia, December 3th, 2009

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

09/12/2010

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Allergic rhinitis

Intervention(s):

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 means of drinking solution mixed with juice were given. Experimental group AM (Seawater): For nasal wash Seawater (AM) extracted from offshore and diluted at a concentration of 0.9% (w / v). Two nasal washes per day in weeks 1 and 2, and one wash per day in weeks 3 to 12. Daily intake of 50 mL of AM (3.5% (w / v)) mixed with the usual drink. Control group (SS) Saline solution: For nasal wash isotonic NaCl 0.9% (w / v). Two nasal washes per day in weeks 1 and 2, and one wash per day in weeks 3 to 12. Daily intake of 50 mL of SS (3.5% (w / v)) mixed with the usual drink. Note: (w / v) = weight / volume.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

2 years

Maximum age:

6 years

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

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

3

Target sample size:

240

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Wilmer

Last Name:

Soler-Terranova

Specialty:

Biochemistry, MSc

Affiliation:

University of Antioquia

Postal Address:

Research Center, Sede de Investigación Universitaria SIU , University of Antioquia, Tower 1, ofice 213

City:

Medellin

Country:

Colombia

Zip Code:

050010474

Telephone:

+574-2196480

Email :

solerw2@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Wilmer

Last Name:

Soler-Terranova

Specialty:

Biochemistry MSc.

Affiliation:

University of Antioquia

Postal Address:

Research Center, Sede de Investigación Universitaria (SIU), University of Antioquia, Torre 1, ofice 213, Calle 62 # 52-59

City:

Medellin

Country:

Colombia

Zip Code:

050010474

Telephone:

+574-2196480

Email :

solerw2@gmail.com

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000200

Date of Registration in Primary Registry:

25/09/2015

Record Verification Date:

2015/09/25

Next update date:

2016/09/25

Link to the spanish version:

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Seawater-Rhinitis-Children-Phase III

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