None listed
Conditions
Brief summary
This is a single-centre, randomized, controlled, cross-over clinical study investigating the deposition of aerosols generated by the Nasal Mesh Prototype (NMN) device at different pulse frequencies to clinically relevant sites within the nasal cavity of 20 patients that have undergone FESS. The study will be performed in adult participants that have previously undergone FESS. Employing a cross-over design enable each subject to act as its own control and reduces the overall number of patients to assess aerosol deposition. The study will comprise four Study Periods, with one treatment (pulse frequency setting) tested per Period. The treatment sequence for the study subjects will be randomly applied, with a brief saline washout period between treatments. Each subject will receive the same amount (1-2 mL) of fluorescein-dyed saline solution (5% FluoresciteTM sterile fluorescein solution) for each treatment. Endoscopic videos of each subject will be taken immediately and at 5, 10 and 15 minutes after self-administration of 1-2 mL fluorescein-dyed saline with the NMN device to each nare. The final assessment at 15 minutes is consistent with the study by Bleier et al and is expected given the known rates of mucociliary clearance in the paranasal sinuses. Screenshots of 5 standard sites (surgically expanded ostia of paranasal sinuses and the oropharynx) will be taken using a 2.7 mm rigid endoscope fitted with a blue light filter at 100% light intensity (Karl Storz, Tuttlingen, Germany). Nasal deposition, clearance and retention of fluorescein-dyed saline solution will be assessed through the analysis of endoscopic images in PhotoShop (Adobe Systems, Inc. San Jose, CA). This will included the evaluation of the number and intensity of fluorescein-laden pixels in endoscopic images taken from the 5 standardized sites within the nasal cavity. Nasal deposition, clearance and retention will be determined and compared between the different pulsed application methods and the continuous method (no pulse).
Interventions
The participant will be randomly allocated to a treatment sequence which will determine the order in which the aerosol deposition assessments are performed. During each treatment period, the pulse frequency of the saline delivered by the device is different..
During each study period when the assessment is being conducted, it involves the following steps:
1. The nasal aerosol assessment involves the delivery into the nose 1-2mL of fluorescein-dyed saline. The device will deliver the dyed salin
The participant will be randomly allocated to a treatment sequence which will determine the order in which the aerosol deposition assessments are performed. During each treatment period, the pulse frequency of the saline delivered by the device is different.. During each study period when the assessment is being conducted, it involves the following steps: 1. The nasal aerosol assessment involves the delivery into the nose 1-2mL of fluorescein-dyed saline. The device will deliver the dyed saline to each side of the nose. The study subject will apply the device at the site under the investigator's supervision 2. Endoscopic assessment will be performed immediately following the delivery of the dyed-saline with the NMN, and 5,10 and 15 minutes thereafter. 3. Once the endoscopic assessment at 15 minutes has been completed, a saline rinse will be provided to remove the any residual fluorescein-dyed saline with the nasal cavity. Steps 1-3 will be repeated for each of the four study periods. These treatments and inspections will be the same across all four study periods with the only difference being the settings on the NMN device used to deliver the fluorescein-dyed saline aerosol. Additionally, for study periods from 2-4, a brief endoscopic inspection will take place between Steps 1 and 2 above to ensure that all fluorescein-dyed saline from the previous assessment has been washed out.. The washout period consists of flushing both nasals with two bottles of saline (50ml each bottle) after each treatment period.
Sponsors
AFT Pharmaceuticals Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants (both males and females) that have undergone Functional Endoscopic Sinus Surgery (FESS) more than 3 months before the study 2. Age >= 18 years 3. No history of smoking 4. No history of chronic lung diseases including asthma, cystic fibrosis, tuberculosis, chronic obstructive lung disease 5. Normal lung function with stable and reproducible baseline FEV1 of >80% of predicted value following adjustment for height, age, and gender (according to the Global Lung Initiative equation)
Exclusion criteria
1. Significant upper and/or lower respiratory tract infection within the previous 4 weeks 2. History of recurrent lung infections 3. History of chronic lung diseases 4. History of severe or multiple allergies, including hay-fever and perennial rhinitis 5. Participants using nasal decongestant within 14 days of entering the study 6. Participants with documented or suspected, clinically significant alcohol or drug abuse 7. Known history of adverse reaction to fluorescein
Outcome results
None listed