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.
This research study is looking at how well a nasal spray called Actisoufre works for people with common cold symptoms. These symptoms include a blocked nose, runny nose, sneezing, and thick mucus, when they don't need antibiotics. The study involves adults and children over 6 years old. Participants will either receive the Actisoufre spray or a placebo (a spray that looks the same but contains no active medicine). We want to find out if the Actisoufre spray makes these symptoms better compared to the placebo. We'll also look at things like how quickly it helps, changes in sleep quality, and overall quality of life. This is a "Phase 3" study, which means it's a key step in testing if a new treatment is safe and effective.
At a glance
What is this study about?
This study is about a nasal spray called Actisoufre. Researchers want to find out if this spray can help people who have common cold symptoms that affect their nose and throat. These symptoms can include a blocked nose, runny nose, sneezing, and thick mucus. It's for people who don't have a serious infection that would require antibiotics.
To see if the spray works, the study will compare Actisoufre to a 'placebo.' A placebo is a treatment that looks exactly like the real one but doesn't have any active medicine in it. Some people will get Actisoufre, and others will get the placebo. This helps the researchers understand if any improvements are genuinely due to Actisoufre or just happen naturally over time, or because people expect to feel better.
The main thing the researchers are looking for is how much the nasal symptoms improve over four days. They'll also check other things like how well people sleep, their general quality of life, how quickly they feel relief, and if they need to use other nose remedies. They will also keep a close eye on any side effects.
Key takeaways
- Tests a nasal spray (Actisoufre) for common cold symptoms.
- Compares Actisoufre to a dummy spray (placebo).
- Open to adults and children aged 6 and over.
- Focuses on symptoms like blocked nose, runny nose, and sneezing.
- Study participation lasts approximately 8 days.
- Helps understand if Actisoufre is safe and effective.
Who may be eligible?
This study is looking for both male and female volunteers. You need to be at least 18 years old to take part. There is no upper age limit for joining.
To be eligible, you must be experiencing symptoms of a common cold, such as a stuffy or runny nose, sneezing, or thick mucus. Importantly, these symptoms should not be serious enough to need antibiotics.
The study is also open to children aged 6 years and older who have these same cold symptoms. If you're a parent interested in your child participating, you would need to discuss this with the study team.
- Are you 18 years old or older? (Children aged 6+ can also be considered)
- Do you have common cold-like symptoms such as a blocked nose, runny nose, sneezing, or thick mucus?
- Are your symptoms currently mild enough that you don't need antibiotics?
- Are you willing to use a nasal spray and answer questions about your symptoms for about 8 days?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first have a check-up to make sure you're suitable. Once enrolled, you would be randomly assigned to either use the Actisoufre nasal spray or the placebo nasal spray for a period of time. You wouldn't know which one you're getting.
Throughout the study, you'll be asked to answer questionnaires about your nasal symptoms, sleep quality, and general well-being. These questions will be asked at different times: at the start (Day 1), then on Day 2, Day 3, Day 4, and finally on Day 8. You might also be asked about how quickly you feel relief after using the spray and if you need to use any other nasal treatments.
The total duration of your active involvement in the study, including all assessments, would be about 8 days.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is Actisoufre?
Actisoufre is a nasal spray that the study is testing to see if it helps with common cold symptoms like a blocked or runny nose.
What is a placebo?
A placebo is a 'dummy' spray that looks just like the real one but doesn't have any active medicine. It helps researchers compare how well the actual medicine works.
Will I know if I'm getting the real spray or the placebo?
No, this is a 'blinded' study, meaning neither you nor the study doctors will know whether you are receiving Actisoufre or the placebo until the study is over.
How long will I need to be in the study?
Your active participation, including all check-ups and answering questions, will last about 8 days.
What kind of symptoms is this study for?
This study is for common cold symptoms like a blocked nose, runny nose, sneezing, or thick mucus, when you don't need antibiotics.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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