Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

Not Applicable

Completed

• Conditions: Nasal Congestion and Inflammations

• Registration Number: NCT06773013
• Lead Sponsor: Third Wave Therapeutics

Brief Summary

To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-09
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-14
• Primary Completion: 2025-03-16
• Study Completion: 2025-03-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Pediatric subjects between the ages of 12 to 21 years
• Present with symptoms of nasal congestion for 1 month or more prior to treatment
• Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria

• Head, nasal or sinus surgery within 3 months
• Sinus infection diagnosed within the last month, or rhinitis medicamentosa
• Documented history of nasal polyposis or mass
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serious adverse events	2 weeks	Safety
Reduction in nasal congestion subscore	2 weeks	Effectiveness

Secondary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score (TNSS)	2 weeks
Adverse events	2 weeks	Safety

Trial Locations

Locations (1)

Crescendo MD; 🇺🇸 Portola Valley, California, United States