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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Isotonic saline, nasal spray | Placebo Comparator | Isotonic saline, nasal spray 20 ml nasal spray contains Isotonic water solution 0.9% sodium chloride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phytosun, decongestant, nasal spray | Device | one time application of the nasal spray |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| nasal peak inspiratory flow | The measurement of Peak Nasal Inspiratory Flow (PNIF) (litres/minute) will be performed with the In-Check portable nasal flow meter. | within 20 minutes prior to treatment and within 30 minutes after treatment administration |
| Adverse events monitoring |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University | Cardiff | CF10 3AX | United Kingdom |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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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. |
| after all trial related procedures on day 1, which is the day of treatment administration as we only have one visit day. |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |