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A Study Comparing Proponent Solution - Nasal Spray (PSNS) With Salt Water for Treating Nasal Congestion Symptoms in Adults With Rebound Nasal Congestion While Weaning From Nasal Decongestant Sprays

NCT06817967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-04-25

No results posted yet for this study

Summary

The purpose of the study was to test if the PROPONENT® nasal spray works, if it is safe, and if it helps participants to stop using addictive nasal decongestant sprays. To be able to take part in the study, participants had to be at least 18 years old, suffer from a condition called "rebound nasal congestion" or "rhinitis medicamentosa (RM)", and be dependent on nasal decongestants. Participants were randomly assigned to receive either PROPONENT® nasal spray or a nasal spray with physiological saline during the 4-week study treatment period. Neither the participants nor their doctor knew which they were receiving. In total, 194 participants took part in this study in several hospitals in Norway.

The study included three visits to the study center: one at the beginning and one at the end of the treatment period, and a follow-up visit approximately 4 weeks after the end of study treatment. During the study treatment period, participants used 1-2 puffs of study nasal spray in each nostril in the morning and evening. They could use the nasal spray additional times if they felt the need due to nasal congestion, up to a maximum of 16 puffs a day. During they study treatment period, participants were asked to measure every morning and evening how much air they could maximally inhale through their nose using a simple instrument called Peak Nasal Inspiratory Flow (PNIF) meter. At the end of each week of the treatment period, participants were asked to report how bad their nasal problems had been during the past week using electronic questionnaires. At the follow-up visit, participants were asked if they could still manage without the decongestant nasal sprays they had been using before entering the study, and if they felt that they had become addicted to the study nasal spray.

Conditions

  • Rhinitis Medicamentosa

Interventions

DEVICE

PSNS

The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation.

DEVICE

ISNS

The nasal spray was self-administered by study subjects at a maximum daily dose of 16 puffs per day, distributed over 1-2 puffs per nostril 2-4 times per day, depending on symptom severity and their alleviation.

Sponsors & Collaborators

  • Proponent Biotech GmbH

    collaborator UNKNOWN

  • Pharma Nordic AS

    lead INDUSTRY

Principal Investigators

  • Kjetil Høye, MD · Pharma Nordic AS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-25
Primary Completion
2024-07-24
Completion
2024-07-24

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06817967 on ClinicalTrials.gov