Study on Hypertonic Saline Nasal Spray

NCT ID: NCT02100605

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phytosun, decongestant, nasal spray

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

Group Type: ACTIVE_COMPARATOR

Phytosun, decongestant, nasal spray

Intervention Type: DEVICE

one time application of the nasal spray

Isotonic saline, nasal spray

Isotonic saline, nasal spray

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

Group Type: PLACEBO_COMPARATOR

Phytosun, decongestant, nasal spray

Intervention Type: DEVICE

one time application of the nasal spray

Interventions

Phytosun, decongestant, nasal spray

one time application of the nasal spray

Intervention Type: DEVICE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omega Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Eccles, Professor

Role: STUDY_DIRECTOR

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

Moutaz SM Jawad, MB ChB FRCP

Role: PRINCIPAL_INVESTIGATOR

Cardiff University, Cardiff school of biosciences

Locations

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

Cardiff, , United Kingdom

Countries

United Kingdom

Other Identifiers

2014_PhytosunDecon_Cardiff_UK

Identifier Type: -

Identifier Source: org_study_id