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 | Completed

• 1 other identifier: PROUD study
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who did not use xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the clinical study treatment period (PSNS vs ISNS)

  Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)

Secondary Outcomes (7)

• At least a 50% reduction in the use of xylometazoline or oxymetazoline nasal spray for three consecutive days at the end of the study treatment period compared to the use reported before study start (PSNS vs ISNS)

  Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)

• Peak Nasal Inspiratory Flow (PNIF)-score measured in the last week of the study treatment period

  Last week of the study treatment period (Day 27-33)

• NOVAS-score measured in the last week of the study treatment period

  Last week of the study treatment period (Day 27-33)

• NOSE-score measured in the last week of the study treatment period

  Last week of the study treatment period (Day 27-33)

• Temporal trends in PNIF-score during the study treatment period

  From randomisation to end of study treatment (Day 27-33)

Other Outcomes (2)

• Safety: Frequency and severity of adverse events (AEs), adverse device effects (ADEs), device deficiencies, serious adverse events (SAEs), and serious adverse device effects (SADEs)

  From randomisation to end of study i.e., Day 56 (visit window: Day 49 to Day 68)

• Safety: Patient-reported addiction score at the follow-up registration (1 question score)

  Visit 3 (follow-up registration), i.e., Day 56 (visit window: Day 49 to Day 68)

Study Arms (2)

PSNS

EXPERIMENTAL

The PSNS consisted of a Locke-Ringer solution containing 10 mg/mL sodium propionate. The solution was provided in a microbiologically safeguarded, multi-use dosing system consisting of a plastic storage bottle (20 mL) and a nasal applicator. 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. Each puff contained approximately 140 µl nasal spray solution.

Device: PSNS

ISNS

PLACEBO COMPARATOR

The comparator ISNS consisted of water containing 0.9% w/v sodium chloride. The ISNS solution was provided in the same microbiologically safeguarded, multi-use dosing system as the investigational device product. 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. Each puff contained approximately 140 µl nasal spray solution.

Device: ISNS

Interventions

PSNS DEVICE

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.

PSNS

ISNS DEVICE

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.

ISNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed informed consent prior to any study-specific procedures.
• Be 18 years of age or older.
• Use xylometazoline or oxymetazoline nasal spray at least once daily over a period of 7 days, registered before entering the clinical study.
• Be diagnosed with RM by a medical doctor. The subject needed/wanted to wean from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline.

You may not qualify if:

• Had influenza, acute or chronic rhinitis (other than RM), acute sinusitis, suppurative tonsillitis, pneumonia, or tuberculosis.
• Had taken any medication or cold remedies to treat common colds (including Proponent Solution - Nasal Spray \[PSNS\]) within the last week.
• Had used glucocorticoids (tablets, injections, and topical inhalers) within the last week or will need this medication during the study.
• Had serious primary cardiovascular, kidney, liver, neurological, psychiatric, or haematological disease.
• Had a diagnosis of asthma, chronic obstructive pulmonary disease, chronic cough, or other significant acute or chronic respiratory conditions or disorders.
• Study subject was a current smoker.
• Nasal disorder or nasal condition as a relevant septal deviation, polyposis, chronic rhinitis, ulcer, etc., and/or reconstructive surgery, that could impair nasal breathing.
• Had a known ongoing cancer disease.
• Was identified by the Investigator as inappropriate to participate in this study (e.g., inability to report daily using smartphone/computer \[eDiary\]).
• Participated in other clinical trials within the last 3 months.
• Had known allergy or hypersensitivity to the components of the investigational product.
• Were pregnant or nursing.

Sponsors & Collaborators

• Pharma Nordic AS: lead
• Proponent Biotech GmbH: collaborator

Study Sites (7)

Bjørge Øre-Nese-Hals

Ålesund, 6003, Norway

Location

Haukeland Universitetssykehus, Departments of Otolaryngology and Head and Neck Surgery, Helse Bergen

Bergen, 5021, Norway

Location

Stortorget Øre Nese Hals AS

Hamar, 2317, Norway

Location

Hov Legesenter

Hov, 2860, Norway

Location

Sørlandet Sykehus, Kristiansand, Department for Ear, Nose and Throat

Kristiansand, 4615, Norway

Location

Heiaklinikken Legesenter, Helsehuset Lierskogen

Lierskogen, 3420, Norway

Location

Stavanger Øre-Nese-Hals

Stavanger, 4020, Norway

Location

Study Officials

• Kjetil Høye, MD

  Pharma Nordic AS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects were randomly assigned to treatment with PSNS or ISNS using a block size of 4. Randomisation codes were assigned strictly sequentially as subjects were eligible for randomisation. The randomisation list was generated by an independent statistician and was kept strictly confidential. The investigational medicinal device and the comparator nasal spray were distributed in identical packages.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a prospective, randomised, double-blind, multicentre, parallel-group study to evaluate Proponent Solution - Nasal Spray (PSNS) compared to Isotonic Saline Nasal Spray (ISNS) for treatment of nasal congestion symptoms in adult subjects with RM while weaning from direct-acting alpha-adrenergic agonists, such as xylometazoline or oxymetazoline. The study aimed to recruit approximately 200 subjects (actual: 194 subjects) who should receive 4-weeks (28 days, 1 to +5 days) of treatment with PSNS or ISNS, to evaluate the efficacy, safety, and tolerability.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 25, 2024
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (7)