Study on Hypertonic Saline Nasal Spray

Nasal Congestion Clinical Trial

— PhytosunDecon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100605
• Other study ID #: 2014_PhytosunDecon_Cardiff_UK
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: February 19, 2015
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Omega Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Omega Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Adverse events monitoring	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.	No
Primary	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	No