Nasal CongestionEXSPRAYNCT05159271
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults
A study testing Azeol spray nasal in people with Nasal Congestion, run by Larena SAS at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Azeol spray nasal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Nov 2021to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country.
France2 sites
CEN Nutriment
Dijon, 21000
Biofortis - Unité d'investigation clinique
Saint-Herblain, 44800
About this study
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
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.
Read the 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.
- Conditions
- Nasal Congestion
- Being tested
- Azeol spray nasal, Placebo nasal spray
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azeol spray nasalDevice
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).
Placebo nasal sprayDevice
with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Azeol spray nasal group | Experimental | 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. Receives: Device: Azeol spray nasal |
| Placebo group | Placebo comparator | The control product is a placebo with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients Receives: Device: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Secondary outcomes (10)
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
Measured: 7 days
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
Measured: 7 days
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
Measured: 7 days
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
Measured: 7 days
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
Measured: First day
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
Measured: 7 days
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
Measured: 7 days
Subject's assessment of common cold feeling compared to the day before
item 21 of a patient questionnaire (WURSS-21)
Measured: 7 days
Subjects' assessment of efficacy
evaluated at the end of trial visit with a patient's satisfaction questionnaire
Measured: 7 days
Presence of secondary infections in the month after the D7
assessed by investigator
Measured: 1 month after D7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start22 Nov 2021
- Primary completion24 Mar 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159271
- Sponsor's protocol ID
- PEC19217
- Acronym
- EXSPRAY
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD won't be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05159271
- Acronym / sponsor ID
- EXSPRAY / PEC19217
- Conditions
- Nasal Congestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azeol spray nasal group | Experimental | Device: Azeol spray nasalAzéol 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. |
| Placebo group | Placebo comparator | Device: Placebo nasal sprayThe control product is a placebo with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
- 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;
- 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),
Key exclusion criteria (9 listed)
- 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.);
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azeol spray nasalAzeol 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). | Device | Azeol spray nasal group |
| Placebo nasal spraywith the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients | Device | Placebo group |
Primary outcome
relief of nasal congestion at 2 days
Time frame: 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
10 secondary outcomes
relief of nasal congestion
Time frame: 7 days
Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score
Time frame: 7 days
Area Under the Curve for common cold symptoms
Time frame: 7 days
Area Under the Curve for nine quality-of-life items
Time frame: 7 days
Area Under the Curve for the total nasal airway resistance to airflow
Time frame: First day
Time to onset of subjective relief nasal congestion from day 1
Time frame: 7 days
Time to onset of subjective relief symptoms from day 1
Time frame: 7 days
Subject's assessment of common cold feeling compared to the day before
Time frame: 7 days
Subjects' assessment of efficacy
Time frame: 7 days
Presence of secondary infections in the month after the D7
Time frame: 1 month after D7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No. IPD won't be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azeol spray nasal in people with Nasal Congestion, run by Larena SAS at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relief of nasal congestion at 2 days (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.