Clinical study to assess the tolerance and efficacy of a nasal spray: Stérimar Stop & Protect Rhume/Cold for relief of symptoms in patients with an upper respiratory tract infection (common cold)

ISRCTN	ISRCTN14067635
DOI	https://doi.org/10.1186/ISRCTN14067635
Secondary identifying numbers	SSP13081.25

Submission date: 04/03/2021
Registration date: 18/03/2021
Last edited: 22/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The objective of this clinical study is to assess the effects of Stérimar Stop & Protect Rhume/Cold for relief of symptoms in patients with an upper respiratory tract infection (common cold).

Who can participate?
People aged 18 - 60 years old, with symptoms of the common cold.

What does the study involve?
Participants will be randomly allocated to receive either Sterimar S&P Cold or Blocked Nose
They could be used up to 6 times a day, 2 pulverisations into each nostril for 14 days at the maximum.

What are the possible benefits and risks of participating?
None

Where is the study run from?
1. Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci (Italy)
2. Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" (Italy)

When is the study starting and how long is it expected to run for?
December 2015 to July 2018

Who is funding the study?
Church and Dwight (France)

Who is the main contact?
Ms Constance Prime, constance.prime@churchdwight.com

Contact information

Ms Constance Prime
Scientific

Sofibel
110-114 rue Victor Hugo
Levallois-Perret
92686
France

Phone	+33 6 16 14 32 05
Email	constance.prime@churchdwight.com

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Assessment of the tolerance and efficacy of Stérimar Stop & Protect Rhume/Cold - randomized, double-blind, controlled versus Stérimar Hypertonic parallel-group, non-inferiority clinical study
Study objectives	Assessment of the tolerance and efficacy of a nasal spray : Stérimar Stop & Protect Rhume/Cold
Ethics approval(s)	Approved 17/03/2016, Sezione Comitato Etico Area Vasta Nord Ovest (Via Roma 67, 56126 Pisa, Italy; +39 (0)50996111; no email provided), ref: 176/2017/PO
Health condition(s) or problem(s) studied	Upper respiratory tract infection (common cold)
Intervention	The study groups will comprise patients with symptoms of common cold, satisfying the inclusion and exclusion criteria and agreeing to take part in this randomized, double blind, controlled, parallel group, non-inferiority clinical study. Patients will be randomized in a 1:1 ratio, in a double blind way, in one of the 2 arms (Sterimar S&P Cold vs Blocked Nose) The study products were supplied in the form of a 20ml pump delivering doses of 140 μmL, they did not require any specific preparations for use and were provided ready to use. They could be used up to 6 times a day, 2 pulverisations into each nostril for 14 days at the maximum.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sterimar S&P Cold, Sterimar Blocked Nose
Primary outcome measure	Illness severity measured using Wisconsin Upper Respiratory Symptom Survey (WURSS-21) questionnaire each day.
Secondary outcome measures	1. Illness duration measured using Wisconsin Upper Respiratory Symptom Survey (WURSS-21) questionnaire each day until last time answering “Yes” to the question “Do you feel you still have a cold?” 2. Use of rescue medication measured using patient-reported diary each day 3. Patient satisfaction measured using 10-point Likert scale at the final visit of the patient to the center at the end of the study 4. Patient acceptability measured using 10-point Likert scale at the final visit of the patient to the center at the end of the study 5. Patient willingness to use the product in the future measured using 4-point scale at the final visit of the patient to the center at the end of the study 6. Safety measured using means of the assessment of all the adverse or serious adverse events reported during the study recorded to patient diary
Overall study start date	01/12/2015
Completion date	11/07/2018

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	102
Total final enrolment	102
Key inclusion criteria	1. Symptoms of common cold 2. Aged from 18 to 60 years
Key exclusion criteria	1. Patients with symptoms started > 48 hours before enrolment. 2. Patients presenting an oral temperature greater than 38.9°C. 3. Patients with positive results on a streptococcal antigen screening test. 4. Patients with signs of lower respiratory tract disease. 5. Patients with history of allergic (seasonal or perennial) rhinitis or reporting sneezing or itching of the nose or eyes at the time of enrolment. 6. Patients with history of asthma or reporting cough, wheezing or shortness of breath at the time of enrolment. 7. Patients with current or reporting history of recurrent bronchitis, otitis or pharyngitis. 8. Patients with recent or current sinus infection (diagnosed by a physician in the past 30 days) or reporting history of recurrent sinusitis (more than two per years). 9. Patient with immune system disorder (autoimmune and immune deficiency disease such as SLE or AIDS). 10. Patients with a clinical significant cardiovascular, endocrine, neurological, respiratory, or any other current disease considered by the Investigator as an exclusion criterion, e.g. chronic respiratory or lung disease or chronic obstructive pulmonary disease (COPD). 11. Patients with severe nasal septum deviation or other current condition that can cause nasal obstruction, such as nasal polyps or nasal / sinus surgery in the past, able to influence symptoms scores. 12. Pregnant women. 13. Patients using saline nose drops or nasal sprays or pumps other than the study products, antibiotics, antivirals, nasal or systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), intranasal medicines, decongestants, antihistamines, combination cold formulae, Echinacea, supplements containing ≥ 10 mg zinc or ≥ 100 mg vitamin C, i.e. using OTC or prescribed medication (other than for contraception) able to influence symptoms scores at the time of enrolment. 14. Patients with known hypersensitivity or allergy to any component of the study medication or of the rescue medication (acetaminophen). 15. Patients smoking during the past 12 months. 16. Patients with a history of alcohol or drug abuse. 17. Patients participating to any investigational drug trial within 4 weeks before screening.
Date of first enrolment	20/04/2016
Date of final enrolment	23/04/2018

Locations

Countries of recruitment

Italy

Study participating centres

Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci

Pisa
56126
Italy

Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

Catania
95123
Italy

Sponsor information

Church & Dwight (United States)
Industry

Sofibel
110-114 rue Victor Hugo
Levallois-Perret
92686
France

Phone	+33 (0)1 49 68 41 00
Email	Marita.Alegre@churchdwight.com
Website	http://www.churchdwight.com/
"ROR"	https://ror.org/01vaj9161

Funders

Funder type

Industry

Church and Dwight
Private sector organisation / For-profit companies (industry)

Alternative name(s): Church & Dwight Co., Inc., Church & Dwight Company, Inc.
Location: United States of America

Results and Publications

Intention to publish date	01/06/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Editorial Notes

16/03/2021: Trial's existence confirmed by Azienda Ospedaleiro-Universitaria Pisana