Investigation of Nasal Deposition using a Medical Device (Nasal Mesh Nebuliser -NMN)

Phase 1

Completed

• Conditions: chronic rhino-sinusitis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12618000693224
• Lead Sponsor: AFT Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-27
• Study Completion: 2021-01-29
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified