Study on Hypertonic Saline Nasal Spray (PhytosunDecon)

Omega Pharma

Status: Completed

Conditions: Nasal Congestion

Treatments: Device: Phytosun, decongestant, nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100605

2014_PhytosunDecon_Cardiff_UK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Phytosun, decongestant, nasal spray

Active Comparator group

Description:

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

Treatment:

Device: Phytosun, decongestant, nasal spray

Isotonic saline, nasal spray

Placebo Comparator group

Description:

Isotonic saline, nasal spray 20 ml nasal spray contains Isotonic water solution 0.9% sodium chloride

Treatment:

Device: Phytosun, decongestant, nasal spray