None listed
Conditions
Brief summary
Our nose and sinuses produce mucus which contains protective molecules. These molecules are part of our body’s first line of defence known as the innate immune system. However, sometimes when this system is disrupted, we can get diseases like chronic rhinosinusitis with nasal polyps (CRSwNP). People with CRSwNP have their nose and sinuses irritated for more than 3 months. These patients often use nasal saline irrigation for treatment which is a solution that rinses your nose. Previous work from our group has shown that, in healthy volunteers, using irrigation solutions with a lower salt concentration provides an increase in some of these protective molecules. We now want to see if this happens in people with CRSwNP too. Hence, we will compare effect of two different irrigation solutions (isotonic NaCl and low Na) on levels of protective molecules in nasal secretions of people with CRSwNP.
Interventions
There are 2 intervention groups. In one group, the participants will be prescribed an isotonic NaCl nasal saline irrigation, specifically FLO Sinus Care. In the other group, the participants will be prescribed a low-Na nasal saline irrigation, specifically FLO CRS. Volunteers will be assigned to one of these two groups randomly.
Both of the nasal saline irrigation solutions will be prescribed for 14 days. Participants will be given sachets of either FLO Sinus Care powder or sachets of FLO CRS p
There are 2 intervention groups. In one group, the participants will be prescribed an isotonic NaCl nasal saline irrigation, specifically FLO Sinus Care. In the other group, the participants will be prescribed a low-Na nasal saline irrigation, specifically FLO CRS. Volunteers will be assigned to one of these two groups randomly. Both of the nasal saline irrigation solutions will be prescribed for 14 days. Participants will be given sachets of either FLO Sinus Care powder or sachets of FLO CRS powder, depending on their assigned group. The sachets are blank so they will not know which one they are assigned to. The sachets can be used for making the solution which is then to be used in a sinus wash bottle. For making and using the solution, the wash bottle and its parts need to be washed well first with warm soapy water and dried. Then, lukewarm pre-boiled water needs to be added into the wash bottle until the filling line. Then, sachet contents need to be added into the filled bottle. Finally, screw the cap and tube before shaking the bottle gently to ensure the powder is dissolved into the lukewarm pre-boiled water used. While bending forward and tilting head down, the final solution is then administered into one nostril using the wash bottle cap while allowing drainage from the opposite nostril. The remaining solutions needs to be discarded and wash bottle washed and dried again. Participants will be prescribed one sachet per day for 14 days. Verbal confirmation at end of study on day 14 will be used to access adherence to the intervention.
Sponsors
Adelaide Specialist Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with chronic rhinosinusitis with polyps
Exclusion criteria
Previous history of nasal/sinus surgery other than adenoidectomy at =16 years, known head and neck malignancies or a history of previous radiotherapy to the head and neck, known MCC disorders, atypical disease, pregnant, severe septal deviation, and use of anticoagulants/aspirin or systemic steroids in the previous 4 weeks
Outcome results
None listed