Study on Hypertonic Saline Nasal Spray

NCT02100605 | Completed DMC

• 1 other identifier: 2014_PhytosunDecon_Cardiff_UK
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Congestion

Keywords

Nasal; Congestion; Decongestion; Hypertonic; Saline solution

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• nasal peak inspiratory flow

  within 20 minutes prior to treatment and within 30 minutes after treatment administration

• Adverse events monitoring

  after all trial related procedures on day 1, which is the day of treatment administration as we only have one visit day.

Study Arms (2)

Phytosun, decongestant, nasal spray

ACTIVE COMPARATOR

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

Isotonic saline, nasal spray

PLACEBO COMPARATOR

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

Device: Phytosun, decongestant, nasal spray

Interventions

Phytosun, decongestant, nasal spray DEVICE

one time application of the nasal spray

Isotonic saline, nasal spray; Phytosun, decongestant, nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have a known hypersensitivity or are allergic to any component of the test product
• 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 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 -

Sponsors & Collaborators

• Omega Pharma: lead

Study Sites (1)

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

Cardiff, CF10 3AX, United Kingdom

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Ron Eccles, Professor

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

  STUDY DIRECTOR

• Moutaz SM Jawad, MB ChB FRCP

  Cardiff University, Cardiff school of biosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: April 1, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

GB (1)