NCT04230993

Brief Summary

The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

January 3, 2020

Last Update Submit

July 9, 2020

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Effect of nasal washing with a hypertonic seawater solution Nose hygiene).

    Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3.

    3 days

Secondary Outcomes (8)

  • Symptom score

    7 days

  • Presence or absence of fluid mucus

    7 days

  • Global Clinical Impression Scale

    between day 3 and day 7

  • Global Patient Impression Scale

    between day 3 and day 7

  • Use of medical device

    7 days

  • +3 more secondary outcomes

Study Arms (3)

Ocean Bio Actif-Fluid+

EXPERIMENTAL

Moderate hypertonic seawater solution (15 g / L NaCl) with polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.

Other: Sea water solution

Ocean Bio Active-Stuffy nose

EXPERIMENTAL

Moderate hypertonic seawater solution (15 g / L NaCl) without polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.

Other: Sea water solution

Ocean Bio Active-Hygiene of the nose

ACTIVE COMPARATOR

Isotonic seawater solution (9 g / L NaCl). The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.

Other: Sea water solution

Interventions

Sea water solutionOTHER

Administration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated.

Ocean Bio Actif-Fluid+Ocean Bio Active-Hygiene of the noseOcean Bio Active-Stuffy nose

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)
  • Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device
  • have given their written informed consent

You may not qualify if:

  • Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis…)
  • Patient allergic to seafood, or to any of the components of the products under study
  • Patient participating or having participated in any other clinical study in the 30 days before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical office

Oignies, France

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Alain BOYE, MD

    Coordinator of the study

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 18, 2020

Study Start

December 24, 2019

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)