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Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults (EXSPRAY)

Primary Purpose

Nasal Congestion

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Azeol spray nasal
Placebo nasal spray
Sponsored by
Larena SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Congestion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

I1. Subject aged between 18 and 65 years (limits included); I2. Subjects with early symptoms of common cold (onset less than or equal to 48 hours before inclusion upon subjects' declaration);

I3. Subjects with:

  • A minimum nasal congestion score (blocked nose) of 2 (moderate) according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert scale,
  • Presenting a minimum of two common cold symptoms (runny nose, blocked nose, sore throat, and/or cough) at inclusion visit (V1) assessed with a score ≥ 1 according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert,
  • Minimum plugged nose (nasal congestion) score of 3 (≥ 3) assessed by WURSS-21;

I4. For women:

  • Non menopausal with the same reliable contraception since at least 2 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel, any oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, surgical intervention (bilateral tubal ligation or ovariectomy or hysterectomy), ESSURE system),
  • Menopausal without or with hormone replacement therapy; I5. Subject with good general and mental health according to the investigator opinion: no clinically significant and relevant abnormalities of medical history or physical examination; I6. Subject able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form; I7. Subject affiliated with a social security scheme; I8. Subject who agree to be registered on the volunteers in biomedical research file.

Exclusion Criteria:

E1. Subjects with nasal polyps/polyposis or nasal septum malformations or other nasal structural abnormalities that would compromise administration of the nasal spray (based on the declaration of the subjects); E2. Subjects with any other acute ear, nose, and throat and respiratory tract disease than the common cold (eg, tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic rhinitis; E3. Subject suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, or other chronic respiratory trouble, etc.);

E4. Subject under:

  • Concomitant treatment that might impair the trial results (eg, decongestants, local anesthetics, topical corticosteroids, saline solution) during the seven days prior to enrollment in the trial,
  • Cough treatment or NSAID or any other treatment for the common cold during the seven days prior to enrollment in the trial,
  • Any dietary supplement or probiotic; E5. Subjects with known or suspected hypersensitivity to the investigational device ingredients or to ingredients which could cause crossed allergia as cypress, peach or citrus fruit; E6. Subjects not fully vaccinated against SARS-CoV-2 virus; E7. Subjects positive for SARS-CoV-2 tested by rapid antigen test at V1; E8. Subjects with fever ≥ 38 °C; E9. Pregnant or lactating women or intending to become pregnant within the month ahead and during the whole study;

E10. Having a lifestyle deemed incompatible with the study according to the investigator as described below:

  • Consuming more than 2 standard drinks of alcoholic daily or 14 weekly or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
  • Smoking more than five cigarettes daily or more than 60 mg of nicotine daily,
  • Practicing high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded); E11. Subject taking part in another clinical trial or being in the exclusion period of a previous clinical trial; E12. Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; E13. Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; E14. Subject presenting a psychological or linguistic inability to sign the informed consent;

Sites / Locations

  • CEN Nutriment
  • Biofortis - Unité d'investigation cliniqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azeol spray nasal group

Placebo group

Arm Description

Azéol Spray Nasal is a nasal spray. The constituents responsible for achieving the intended action are: Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol.

The control product is a placebo with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients

Outcomes

Primary Outcome Measures

relief of nasal congestion at 2 days
change from baseline in the relief of nasal congestion defined by "plugged nose", after 2 days of product intake, assessed at end of day after both spraying sessions with the "plugged nose" question

Secondary Outcome Measures

relief of nasal congestion
Change from baseline in the relief of nasal congestion, assessed at the end of each day after both spraying sessions with a patient questionnaire
Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score
Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score, assessed at the end of each day after both spraying sessions with a patient questionnaire
Area Under the Curve for common cold symptoms
Area Under the Curve for common cold symptoms assessed at the end of each day after both spraying sessions with a patient questionnaire
Area Under the Curve for nine quality-of-life items
Area Under the Curve for nine quality-of-life items (Think clearly; Sleep well; Breathe easily; Walk, climb stairs, exercise; Accomplish daily activities; Work outside the home; Work inside the home; Interact with others; Live your personal life), assessed at the end of each day after both spraying sessions with a patient questionnaire
Area Under the Curve for the total nasal airway resistance to airflow
Area Under the Curve for the total nasal airway resistance to airflow using the rhinomanometry after treatment at day 1
Time to onset of subjective relief nasal congestion from day 1
relief of symptoms defined when symptom absent is declared for plugged nose with a patient questionnaire
Time to onset of subjective relief symptoms from day 1
relief of symptoms defined when symptom absent is declared for all symptoms with a patient questionnaire
Subject's assessment of common cold feeling compared to the day before
item 21 of a patient questionnaire (WURSS-21)
Subjects' assessment of efficacy
evaluated at the end of trial visit with a patient's satisfaction questionnaire
Presence of secondary infections in the month after the D7
assessed by investigator

Full Information

First Posted
November 16, 2021
Last Updated
December 2, 2021
Sponsor
Larena SAS
Collaborators
BioFortis
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1. Study Identification

Unique Protocol Identification Number
NCT05159271
Brief Title
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults
Acronym
EXSPRAY
Official Title
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults: the EXSPRAY Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Larena SAS
Collaborators
BioFortis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective is to evaluate the efficacy of Azéol Spray Nasal, taken two times a day, versus placebo on nasal congestion in subject with common cold.
Detailed Description
This study is designed as a multicentric, randomized, double-blind, placebo-controlled with two-arm parallel groups clinical trial. 144 subjects presenting with early symptoms of common cold will be recruited for this study, according to the defined inclusion and exclusion criteria. The main objective is to evaluate the efficacy of Azéol Spray Nasal (Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol), taken two times a day, versus placebo on nasal congestion in subject with common cold.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Congestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azeol spray nasal group
Arm Type
Experimental
Arm Description
Azéol Spray Nasal is a nasal spray. The constituents responsible for achieving the intended action are: Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The control product is a placebo with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
Intervention Type
Device
Intervention Name(s)
Azeol spray nasal
Intervention Description
Azeol Spray Nasal is a nasal spray intended to reduce the nasal congestion due to rhinitis, rhinosinusitis and colds which is marketed. The ID is conforming to the European Union (EU) legislation and is bearing the CE-mark. The ID is manufactured by PILEJE S.A.S (France).
Intervention Type
Device
Intervention Name(s)
Placebo nasal spray
Intervention Description
with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
Primary Outcome Measure Information:
Title
relief of nasal congestion at 2 days
Description
change from baseline in the relief of nasal congestion defined by "plugged nose", after 2 days of product intake, assessed at end of day after both spraying sessions with the "plugged nose" question
Time Frame
2 days
Secondary Outcome Measure Information:
Title
relief of nasal congestion
Description
Change from baseline in the relief of nasal congestion, assessed at the end of each day after both spraying sessions with a patient questionnaire
Time Frame
7 days
Title
Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score
Description
Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score, assessed at the end of each day after both spraying sessions with a patient questionnaire
Time Frame
7 days
Title
Area Under the Curve for common cold symptoms
Description
Area Under the Curve for common cold symptoms assessed at the end of each day after both spraying sessions with a patient questionnaire
Time Frame
7 days
Title
Area Under the Curve for nine quality-of-life items
Description
Area Under the Curve for nine quality-of-life items (Think clearly; Sleep well; Breathe easily; Walk, climb stairs, exercise; Accomplish daily activities; Work outside the home; Work inside the home; Interact with others; Live your personal life), assessed at the end of each day after both spraying sessions with a patient questionnaire
Time Frame
7 days
Title
Area Under the Curve for the total nasal airway resistance to airflow
Description
Area Under the Curve for the total nasal airway resistance to airflow using the rhinomanometry after treatment at day 1
Time Frame
First day
Title
Time to onset of subjective relief nasal congestion from day 1
Description
relief of symptoms defined when symptom absent is declared for plugged nose with a patient questionnaire
Time Frame
7 days
Title
Time to onset of subjective relief symptoms from day 1
Description
relief of symptoms defined when symptom absent is declared for all symptoms with a patient questionnaire
Time Frame
7 days
Title
Subject's assessment of common cold feeling compared to the day before
Description
item 21 of a patient questionnaire (WURSS-21)
Time Frame
7 days
Title
Subjects' assessment of efficacy
Description
evaluated at the end of trial visit with a patient's satisfaction questionnaire
Time Frame
7 days
Title
Presence of secondary infections in the month after the D7
Description
assessed by investigator
Time Frame
1 month after D7
Other Pre-specified Outcome Measures:
Title
Presence of cold viruses in nasal fluid samples
Description
Viral load (change from baseline) on Day 3 for various virus types and number of subjects with cleared viral infections
Time Frame
3 days
Title
Safety endpoint
Description
The hemodynamic parameters, resting Heart Rate, Systolic Blood Pressure and Diastolic Blood Pressure
Time Frame
First day and 3 days
Title
Safety endpoint
Description
Frequency of adverse events
Time Frame
1 month after D7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: I1. Subject aged between 18 and 65 years (limits included); I2. Subjects with early symptoms of common cold (onset less than or equal to 48 hours before inclusion upon subjects' declaration); I3. Subjects with: A minimum nasal congestion score (blocked nose) of 2 (moderate) according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert scale, Presenting a minimum of two common cold symptoms (runny nose, blocked nose, sore throat, and/or cough) at inclusion visit (V1) assessed with a score ≥ 1 according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert, Minimum plugged nose (nasal congestion) score of 3 (≥ 3) assessed by WURSS-21; I4. For women: Non menopausal with the same reliable contraception since at least 2 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel, any oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, surgical intervention (bilateral tubal ligation or ovariectomy or hysterectomy), ESSURE system), Menopausal without or with hormone replacement therapy; I5. Subject with good general and mental health according to the investigator opinion: no clinically significant and relevant abnormalities of medical history or physical examination; I6. Subject able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form; I7. Subject affiliated with a social security scheme; I8. Subject who agree to be registered on the volunteers in biomedical research file. Exclusion Criteria: E1. Subjects with nasal polyps/polyposis or nasal septum malformations or other nasal structural abnormalities that would compromise administration of the nasal spray (based on the declaration of the subjects); E2. Subjects with any other acute ear, nose, and throat and respiratory tract disease than the common cold (eg, tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic rhinitis; E3. Subject suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, or other chronic respiratory trouble, etc.); E4. Subject under: Concomitant treatment that might impair the trial results (eg, decongestants, local anesthetics, topical corticosteroids, saline solution) during the seven days prior to enrollment in the trial, Cough treatment or NSAID or any other treatment for the common cold during the seven days prior to enrollment in the trial, Any dietary supplement or probiotic; E5. Subjects with known or suspected hypersensitivity to the investigational device ingredients or to ingredients which could cause crossed allergia as cypress, peach or citrus fruit; E6. Subjects not fully vaccinated against SARS-CoV-2 virus; E7. Subjects positive for SARS-CoV-2 tested by rapid antigen test at V1; E8. Subjects with fever ≥ 38 °C; E9. Pregnant or lactating women or intending to become pregnant within the month ahead and during the whole study; E10. Having a lifestyle deemed incompatible with the study according to the investigator as described below: Consuming more than 2 standard drinks of alcoholic daily or 14 weekly or not agreeing to keep his alcohol consumption habits unchanged throughout the study, Smoking more than five cigarettes daily or more than 60 mg of nicotine daily, Practicing high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded); E11. Subject taking part in another clinical trial or being in the exclusion period of a previous clinical trial; E12. Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; E13. Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; E14. Subject presenting a psychological or linguistic inability to sign the informed consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Gal
Phone
0145517877
Ext
+33
Email
c.gal@pileje.com
Facility Information:
Facility Name
CEN Nutriment
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zakaria Nafli
Phone
0380680506
Ext
+33
Facility Name
Biofortis - Unité d'investigation clinique
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Metreau
Phone
0240205799
Ext
+33

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD won't be shared

Learn more about this trial

Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults

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