BridgeMD
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.
EU CTIS ID: 2024-516284-90-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent.
- Age: children 6-18 years old and adults 18- 70 years old.
- Sex: male & female subjects.
- 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)
- Patient having the cognitive and functional abilities for answering the symptom specific questions.
- 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.
You likely can't join if
- Body temperature greater than 38°C measured on the forehead or neck with a non-contact infrared thermometer at enrolment.
- Sinus or any other nasal post-surgery care.
- Any contraindications for application of Actisoufre solution for nasal spray.
- 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.
- 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.).
- Any kind of immunodeficiency.
See the full eligibility criteria
Who can join
- Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent.
- Age: children 6-18 years old and adults 18- 70 years old.
- Sex: male & female subjects.
- 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)
- Patient having the cognitive and functional abilities for answering the symptom specific questions.
- 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.
- Patient willing and able to understand the study information and comply with all the study activities and procedures.
What rules you out
- Body temperature greater than 38°C measured on the forehead or neck with a non-contact infrared thermometer at enrolment.
- Sinus or any other nasal post-surgery care.
- Any contraindications for application of Actisoufre solution for nasal spray.
- 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.
- 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.).
- Any kind of immunodeficiency.
- Hypersensitivity or allergy or intolerance to any component of the ingredients of the trial intervention.
- Positive medical history to any significant infection within the 2 weeks prior to the enrolment.
- Known current pregnancy or breast-feeding.
- Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).
- Any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment.
- Acute tonsillitis at the day of enrolment.
- 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.
- Prior upper respiratory tract infection within 2 weeks prior to enrollment.
- 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.
- 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.
- Use of anti-snoring sprays into the nose and/or pharynx.
- Previous sinus surgery within 6 months prior to enrolment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.