Study on Hypertonic Saline Nasal Spray

Not Applicable

Completed

• Conditions: Nasal Congestion
• Interventions: Device: Phytosun, decongestant, nasal spray

• Registration Number: NCT02100605
• Lead Sponsor: Omega Pharma

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged18 years and over
2. Has given written informed consent, and received a copy of their signed consent form prior to any study related procedures
3. 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).
4. Subject on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale

Exclusion Criteria

1. Have a known hypersensitivity or are allergic to any component of the test product
2. 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
3. The subject has a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
4. The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
5. The subject has a history of alcohol or other substance abuse in previous year
6. 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.
7. The subject has had common cold or flu like symptoms for more than seven days
8. 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)
9. The subject is a current smoker (more than 2 cigarettes, pipes, cigars a day)
10. The subject is related to any study personnel
11. The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
12. The subject is pregnant or lactating -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotonic saline, nasal spray	Phytosun, decongestant, nasal spray	Isotonic saline, nasal spray 20 ml nasal spray contains Isotonic water solution 0.9% sodium chloride
Phytosun, decongestant, nasal spray	Phytosun, decongestant, nasal spray	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

Primary Outcome Measures

Name	Time	Method
assessment of the speed of relief nasal congestion	within 600 seconds after treatment administration	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

Trial Locations

Locations (1)

Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University; 🇬🇧 Cardiff, United Kingdom