Clinical trial NCT02100605: Study on Hypertonic Saline Nasal Spray
Official title: A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion
Keywords: Nasal
Congestion
Decongestion
Hypertonic
Saline solution
Lead sponsor: Omega Pharma
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: assessment of the speed of relief nasal congestion
timeFrame: within 600 seconds after treatment administration
Secondary outcomes:
Other outcomes:
measure: nasal peak inspiratory flow
timeFrame: within 20 minutes prior to treatment and within 30 minutes after treatment administration
measure: Adverse events monitoring
timeFrame: after all trial related procedures on day 1, which is the day of treatment administration as we only have one visit day.
Locations:
city: Cardiff
country: United Kingdom
facility: Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University
Study officials:
affiliation: Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University
name: Ron Eccles, Professor
role: STUDY_DIRECTOR
affiliation: Cardiff University, Cardiff school of biosciences
name: Moutaz SM Jawad, MB ChB FRCP
role: PRINCIPAL_INVESTIGATOR
References: