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

This was a prospective, randomised, double-blind, multicenter, parallel-group study to evaluate Proponent Solution - Nasal Spray (PSNS) compared to sodium chloride 0.9% (Isotonic Saline Nasal Spray [ISNS]) for treatment of nasal congestion symptoms during 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 of treatment with PSNS or ISNS to evaluate the efficacy, safety, and tolerability.

Before study start, prospective subjects received a telephone call by the study personnel where they were informed about the study and asked to make notes of their daily use of xylometazoline or oxymetazoline each evening (including the number of doses used) for 7 days prior to start of study treatment. This data was transferred to an electronic diary (eDiary) for all subjects that were included in the study. Prospective subjects attended an enrolment visit (Visit 1) at the investigational site, where informed consent was discussed and signed. Eligible subjects were randomised (1:1) to receive the investigational device product (PSNS) or the comparator (ISNS), and self-administered the first dose of study treatment under supervision of the study personnel.

During the 4-week treatment period (28 days, -1 to +5 days), subjects self-administered the study nasal spray at a maximum dose of 16 puffs per day distributed over 1-2 puffs applied into each nostril 2-4 times daily. Subjects were asked to report daily their objective morning and evening PNIF meter results in an eDiary on a smartphone or laptop both before and 10 minutes after administration of 1-2 puffs of either PSNS or the comparator. Each week, subjects had to fill out electronic questionnaires assessing their nasal congestion/obstruction using validated scoring systems (NOSE and NOVAS-score). At 21-35 days after the end of study treatment (Visit 3), each subject was asked to complete a follow-up registration in the eDiary. During this assessment, it was also assessed whether the subject had become addicted to/physically dependent on the study nasal spray.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Had an allergic disease and require daily peroral antihistamines for the treatment of the disease during the inclusion period and the study.
• 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.