Intranasal Deposition of fluorescein-dyed Saline delivered by a Nasal Mesh Nebulizer (NMN) at different pulse frequencies in patients that have undergone Functional Endoscopic Sinus Surgery (FESS)

Phase 1

• Conditions: Patients who undergone functional endoscopic sinus surgery; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12616001397404
• Lead Sponsor: AFT Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified