Study on Hypertonic Saline Nasal Spray

Study Overview
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Brief Summary
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Phytosun decongestant nasal spray is a class I medical device registered in the European Union for the treatment of nasal congestion. The spray contains hypertonic seawater and essential oils. The objective of the study is to investigate the effects of a nasal spray, registered as a medical device under the name Phytosun Decongestant in the European Union, on speed of onset of relief of nasal congestion in 50 subjects suffering from nasal congestion associated with common cold.

Detailed Description
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The study will also include an exploratory assessement of any objective changes in nasal patency by measuring nasal peak inspiratory flow before and after treatment.

Official Title
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A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant)

Conditions
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Nasal Congestion

Intervention / Treatment
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* Device: Phytosun, decongestant, nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged18 years and over Has given written informed consent, and received a copy of their signed consent form prior to any study related procedures Subject considers they are suffering from a common cold of no more than 7 days duration (common cold will be self-diagnosed but all patients will be screened by a doctor and nasal examinations will be performed as needed to establish eligibility of patients for study). Subject on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale Exclusion Criteria: Have a known hypersensitivity or are allergic to any component of the test product The subject has a clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease The subject has a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps. The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores The subject has a history of alcohol or other substance abuse in previous year The subject is taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics. The subject has had common cold or flu like symptoms for more than seven days The subject has recently taken a common cold medicine that in the opinion of the investigator may influence baseline symptom scores (such as nasal decongestants) The subject is a current smoker (more than 2 cigarettes, pipes, cigars a day) The subject is related to any study personnel The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study The subject is pregnant or lactating -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phytosun, decongestant, nasal spray<br>Phytosun, decongestant, nasal spray Nasal spray 20 ml contains: 22g/l hypertonic seawater Essential oils of Eucalyptus, Niaouli and Wild menthol Instructions for use: Shake the bottle before use Tilt the bottle to one side; press the nozzle firmly for at least one second, repeat until obtaining the 1st spray. Spray in each nostril with the head upright | Device: Phytosun, decongestant, nasal spray<br>* one time application of the nasal spray<br>|
| Placebo Comparator: Isotonic saline, nasal spray<br>Isotonic saline, nasal spray 20 ml nasal spray contains Isotonic water solution 0.9% sodium chloride | Device: Phytosun, decongestant, nasal spray<br>* one time application of the nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the speed of relief nasal congestion | Subjects will be instructed that the investigator will administer one spray of the treatment into each nasal passage and then start a stop clock. The subject will be asked to stop the clock immediately when they feel any relief of nasal congestion. A sign with the following wording will be placed near the stop-clock. STOP THE CLOCK IMMEDIATELY YOU FEEL RELIEF OF NASAL CONGESTION The clock will be stopped after 600 seconds even if the subject does not respond | within 600 seconds after treatment administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal, Congestion, Decongestion, Hypertonic, Saline solution