Investigation of Nasal Deposition using a Medical Device (Nasal Mesh Nebuliser -NMN)
A single center, randomized, controlled, four way cross-over clinical study investigating the deposition of aerosol generated by the Nasal Mesh Nebulizer (NMN) prototype into the nasal cavity using radio-labelled saline at different pulse frequency in healthy volunteers.
AFT Pharmaceuticals Ltd.
20 participants
Apr 10, 2018
Interventional
Conditions
Summary
This is an exploratory study using a new clinical NMN prototype to determine the regional depositions in the nasal cavity of aerosols using different pulse frequency modes in healthy volunteers. The main objective of the study is to determine the optimal frequency for the NMN that will provide the basis for future in vivo sinus targeting of drug delivery systems. The primary endpoint of this study is the total area of distribution (mm2) of radiolabelled saline immediately after administration by the NMN (T0) in the different regions of the sinus cavity.
Eligibility
Inclusion Criteria7
- Healthy Caucasian male
- Aged >20 years
- No history of smoking
- No history of chronic lung diseases including asthma, cystic fibrosis, tuberculosis, chronic obstructive lung disease
- 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.
- No history of chronic sinusitis or rhinitis
- Agree that CT scan data can be used post-study to generate an anatomically correct model of the upper respiratory tract
Exclusion Criteria18
- Significant upper and lower respiratory infection within the previous 4 weeks
- History of chronic sinusitis or rhinitis
- History of recurrent lung infections.
- History of chronic lung diseases
- History of severe or multiple allergies, including hay-fever and perennial rhinitis
- History of nasal fracture, nasal deformities or nasal polyps
- History of disease, surgery, or abnormality of the upper respiratory tract, especially the nasal cavity.
- History of significant nose bleeds
- Participants using topical nasal medication e.g. decongestant, within the last 14 days of the first study day
- Participants unable to perform pulmonary function test according to ATS/ERS criteria
- Participants with documented or suspected, clinically significant alcohol or drug abuse
- Current malignant or cardiovascular disease
- Any serious or active medical or psychiatric illness
- Current smokers, i.e. those who had smoked within the last 12 months and 6 hours prior to the scan. A negative Cotinine test must be demonstrated at each visit.
- Participants who have any non-removable metal objects such as pacemakers, insulin/infusion pumps, cochlear and ear implant, metal plates, screws etc. in their head, neck, chest or abdominal area that may interfere with the /PET/SPECT/CT.
- Nasal jewellery or nasal piercing
- Participants with tattoos or permanent makeup above shoulder
- Participants for whom participation in this study will exceed the limit of total radiation exposure allowed in any 12 months period (5 mSv), or will exceed 10 mSv over the last five-year period
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Interventions
The intervention is the treatment of a single intranasal dose of 2ml radio-labelled saline (an isotonic saline solution will be mixed and delivered together with the technetium labelled diethylene triamine petaacetic acid (99m Tc-DTPA). delivered by a nasal mesh nebulizer (NMN) device applied to both nostrils (starting with left nostril and the alternating both nostrils) at different pulse frequencies under the supervision of the study staff: Treatment A; No pulse (continuous mode) Treatment B: 10 Hz pulse Treatment C: 50 Hz pulse Treatment D: 100 Hz pulse Between each two treatments, there will be at least 72 -hours washout period. Participants will receive each treatment in a cross-over way. For each eligible subject, they will be randomly allocated to a treatment sequence. according to the site master randomization list kept by the study staff. The healthy subject will be trained by the site staff to use the medical device, and then the subject will administer the treatment under the site staff's supervision (different pulse frequency has already been programmed and labelled for each medical device-the site staff will supply the medical device with the correct pulse frequency labelled to the subject). The treatment administration will alternate between left and right nostrils (the device will be activated by exhaling and deliver the aresol) -starting with the left nostril and continue the administration until a " beep" like sound will be heard (approximately 20 times of breathing). To complete all the four study periods and the follow up, each subject will need about 4 weeks to complete the study.
Locations(1)
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ACTRN12618000693224