A prospective, controlled, randomized, double blind, 2-arms, parallel-group, multicentre, phase 3 study to investigate effectiveness of Actisoufre nasal spray in a pressurized container compared to placebo in female and male adult and paediatric population over 6 years old with acute rhinitis, rhinopharyngitis and rhinosinusitis not requiring antibiotic therapy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratoires Grimberg

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2025-09-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of this study is to evaluate the efficacy of Actisoufre, nasal spray in a pressurized container (applied 3 times daily into each nostril for 7 days) when compared to placebo in adult and paediatric subjects over 6 years of age with acute rhinitis, rhinopharyngitis & rhinosinusitis not requiring antibiotic therapy.

Secondary objectives 4

1. To evaluate Actisoufre’s effect on sleep.
2. To assess patient’s subjective impression of Actisoufre efficacy in resolution of symptoms of acute rhinitis/ rhinopharyngitis/ rhinosinusitis.
3. To evaluate Actisoufre’s effect on quality of life.
4. To evaluate safety of Actisoufre, solution for nasal spray.

Conditions and MedDRA coding

rhinosinusitis not requiring antibiotic therapy

Regulatory references

Scientific advice from competent authorities

Office For Registration Of Medicinal Products Medical Devices And Biocidal Products

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent.
2. Age: children 6-18 years old and adults 18- 70 years old.
3. Sex: male & female subjects.
4. Indication: Patients with clinical diagnosis of acute rhinitis, rhinopharyngitis, rhinosinusitis with sudden onset of minimum two relevant symptoms for ≤ 48 hours prior to enrollment, which are nasal blockage/ obstruction/ congestion rhinorrhea (nasal discharge - anterior/ posterior nasal drip)
5. Patient having the cognitive and functional abilities for answering the symptom specific questions.
6. Patients willing to use acceptable birth control methods during the course of the study, that result in a failure rate of more than 1% per year including: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. In case of menstruating adolescents up to 16 years of age, sexual abstinence is acceptable.
7. Patient willing and able to understand the study information and comply with all the study activities and procedures.

Exclusion criteria 18

1. Body temperature greater than 38°C measured on the forehead or neck with a non-contact infrared thermometer at enrolment.
2. Any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment.
3. Acute tonsillitis at the day of enrolment.
4. Use of saline nose drops or nasal sprays or pumps other than the study products, systemic antibiotics, antivirals, intranasal medicines, decongestants, antihistamines, echinacea, combination cold formulas, supplements containing > 10 mg zinc that would influence symptoms scores at enrolment or within 12 hours prior the day of screening.
5. Prior upper respiratory tract infection within 2 weeks prior to enrollment.
6. Chronic allergic or non-allergic rhinitis with symptoms such as chronic nasal obstruction, sneezing, watery rhinorrhea, nasal itching, and itchy watery eyes at the day of enrollment.
7. Use of antibiotics, systemic antiviral medications, corticosteroids (local and systemic), pseudoephedrine, phenylephrine, or anti-allergic treatment (only topical use of corticosteroids for dermatology reasons is allowed) within past 7 days.
8. Use of anti-snoring sprays into the nose and/or pharynx.
9. Previous sinus surgery within 6 months prior to enrolment.
10. Sinus or any other nasal post-surgery care.
11. Any contraindications for application of Actisoufre solution for nasal spray.
12. Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations (detected in anterior rhinoscopy), or history of frequent nosebleeds.
13. Any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, chronic bronchitis, chronic rhinosinusitis, etc.).
14. Any kind of immunodeficiency.
15. Hypersensitivity or allergy or intolerance to any component of the ingredients of the trial intervention.
16. Positive medical history to any significant infection within the 2 weeks prior to the enrolment.
17. Known current pregnancy or breast-feeding.
18. Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of the nasal symptoms (nasal obstruction, rhinorrhea (drip, sniff, snorting, drainage, discharge), thick mucus, sneezing, cough evaluated from baseline at Day 4 based on the specific “Common Cold Symptoms Severity Questionnaire” (CCSS), in the intervention group and in the control group. [Time points of CCSS assessment: Baseline (Day 1), Day 2, Day 3, Day 4, Day 8]

Secondary endpoints 6

1. Change in the quality of sleep in the Actisoufre arm comparing to the placebo. [Time point: Baseline (Day 1), Day 2, Day 3, Day 4, Day 8]
2. Change in patient’s Quality of Life based on the VAS scale [Time point: Baseline (Day 1), Day 4, Day 8]
3. Evaluation of onset of immediate relief after the entire product application is completed at Day 1 (baseline) and once daily up to Day 4 of the study. [Time point: Baseline, Day 2, Day 3, Day 4]
4. Number of subjects with a need of use of nasal decongestants as an emergency treatment. [Time point: Day 8]
5. Assessment of use of concomitant medications (including frequency) from baseline to the end of the study. [Time point: Baseline, Day 4, Day 8]
6. Number of Adverse Events and Serious Adverse Events in intervention group comparing to the control group. [Time point: Baseline, Day 4, Day 8]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratoires Grimberg

Sponsor organisation

Laboratoires Grimberg

Address

44 Avenue Georges Pompidou

City

Levallois-Perret

Postcode

92300

Country

France

Scientific contact point

Organisation

Laboratoires Grimberg

Contact name

Marguerite Durand

Public contact point

Organisation

Laboratoires Grimberg

Contact name

Marguerite Durand

Third parties 1

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications