N/A N=52 Randomized Double-blind Treatment

Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

Nasal Congestion and Inflammations

Bottom Line

View on ClinicalTrials.gov: NCT05821842 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Primary Effectiveness — -0.87; -0.44 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sonu (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Third Wave Therapeutics
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Effectiveness	-0.87; -0.44	—
SECONDARY Secondary Effectiveness	-2.85; -1.32	—

Summary

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

Eligibility Criteria

Inclusion Criteria

18 years of age and older
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05821842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.