A Study Comparing Proponent Solution - Nasal Spray (PSNS) With Salt Water for Treating Nasal Cong… (NCT06817967) | Clinical Trial Compass
CompletedNot Applicable
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
Norway194 participantsStarted 2024-02-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Provide signed informed consent prior to any study-specific procedures.
âś“. Be 18 years of age or older.
âś“. Use xylometazoline or oxymetazoline nasal spray at least once daily over a period of 7 days, registered before entering the clinical study.
âś“. 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.
Exclusion criteria
âś•. Had influenza, acute or chronic rhinitis (other than RM), acute sinusitis, suppurative tonsillitis, pneumonia, or tuberculosis.
âś•. Had taken any medication or cold remedies to treat common colds (including Proponent Solution - Nasal Spray \[PSNS\]) within the last week.
âś•. Had used glucocorticoids (tablets, injections, and topical inhalers) within the last week or will need this medication during the study.
âś•. Had serious primary cardiovascular, kidney, liver, neurological, psychiatric, or haematological disease.
What they're measuring
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)
Timeframe: Day 0 (randomisation, start of treatment) until end of treatment (Day 28, -1 day until + 5 days)
âś•. Had a diagnosis of asthma, chronic obstructive pulmonary disease, chronic cough, or other significant acute or chronic respiratory conditions or disorders.
âś•. Had an allergic disease and require daily peroral antihistamines for the treatment of the disease during the inclusion period and the study.
âś•. Study subject was a current smoker.
âś•. Nasal disorder or nasal condition as a relevant septal deviation, polyposis, chronic rhinitis, ulcer, etc., and/or reconstructive surgery, that could impair nasal breathing.