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Completed

NCT Number: NCT02100605

Study on Hypertonic Saline Nasal Spray

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.

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Key information

Conditions

Nasal Congestion Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University

Cardiff, CF10 3AX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Phytosun, decongestant, nasal spray

Device

one time application of the nasal spray

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Omega Pharma

Industry

Registry information

Official study title

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

Acronym: PhytosunDecon

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2014
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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