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Study on Hypertonic Saline Nasal Spray (PhytosunDecon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02100605
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : February 20, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nasal Congestion Device: Phytosun, decongestant, nasal spray Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant)
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Active Comparator: 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
Device: Phytosun, decongestant, nasal spray
one time application of the nasal spray

Placebo Comparator: Isotonic saline, nasal spray

Isotonic saline, nasal spray

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

Device: Phytosun, decongestant, nasal spray
one time application of the nasal spray

Primary Outcome Measures :
  1. assessment of the speed of relief nasal congestion [ Time Frame: 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

Other Outcome Measures:
  1. nasal peak inspiratory flow [ Time Frame: within 20 minutes prior to treatment and within 30 minutes after treatment administration ]
    The measurement of Peak Nasal Inspiratory Flow (PNIF) (litres/minute) will be performed with the In-Check portable nasal flow meter.

  2. Adverse events monitoring [ Time Frame: after all trial related procedures on day 1, which is the day of treatment administration as we only have one visit day. ]
    Any adverse events (AE) will be documented by asking the subjects to record in the CRF any signs and symptoms after the dose in clinic, Adverse events may also be elicited at the end of the study when the subject is interviewed about their experiences during the study. Adverse events will be recorded in the case report form (CRF) at the final study visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02100605

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United Kingdom
Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University
Cardiff, United Kingdom, CF10 3AX
Sponsors and Collaborators
Omega Pharma
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Study Director: Ron Eccles, Professor Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University
Principal Investigator: Moutaz SM Jawad, MB ChB FRCP Cardiff University, Cardiff school of biosciences

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Responsible Party: Omega Pharma Identifier: NCT02100605     History of Changes
Other Study ID Numbers: 2014_PhytosunDecon_Cardiff_UK
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015
Keywords provided by Omega Pharma:
Saline solution
Additional relevant MeSH terms:
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Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents