Nasal CongestionPhytosunDeconNCT02100605
Study on Hypertonic Saline Nasal Spray
A study testing Phytosun, decongestant, nasal spray in people with Nasal Congestion, run by Omega Pharma at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Phytosun, decongestant, nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University
Cardiff, CF10 3AX
About this study
Official title: A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant)
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.
Read the 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.
- Conditions
- Nasal Congestion
- Being tested
- Phytosun, decongestant, nasal spray
- Keywords
- Nasal, Congestion, Decongestion, Hypertonic, Saline solution
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytosun, decongestant, nasal sprayDevice
one time application of the nasal spray
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Phytosun, decongestant, nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 600 seconds after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omega Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Eccles, Professor, Study director, Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff UniversityMoutaz SM Jawad, MB ChB FRCP, Principal investigator, Cardiff University, Cardiff school of biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100605
- Sponsor's protocol ID
- 2014_PhytosunDecon_Cardiff_UK
- Acronym
- PhytosunDecon
- Status last verified
- Feb 2015
- First submitted
- 21 Mar 2014
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant)
- ClinicalTrials.gov ID
- NCT02100605
- Acronym / sponsor ID
- PhytosunDecon / 2014_PhytosunDecon_Cardiff_UK
- Conditions
- Nasal Congestion
- Keywords
- Nasal, Congestion, Decongestion, Hypertonic, Saline solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Omega PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phytosun, decongestant, nasal spray | Active comparator | Device: Phytosun, decongestant, nasal sprayPhytosun, 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 |
| Isotonic saline, nasal spray | Placebo comparator | Device: Phytosun, decongestant, nasal sprayIsotonic saline, nasal spray 20 ml nasal spray contains Isotonic water solution 0.9% sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phytosun, decongestant, nasal sprayone time application of the nasal spray | Device | Isotonic saline, nasal spray, Phytosun, decongestant, nasal spray |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Eccles, Professor study director
Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University
Moutaz SM Jawad, MB ChB FRCP principal investigator
Cardiff University, Cardiff school of biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytosun, decongestant, nasal spray in people with Nasal Congestion, run by Omega Pharma at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the speed of relief nasal congestion (time frame: within 600 seconds after treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.