Recruitment

Recruitment Status
Completed

Inclusion Criteria

Subject on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale
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 on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale
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).

Exclusion Criteria

The subject has had common cold or flu like symptoms for more than seven days
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 recently taken a common cold medicine that in the opinion of the investigator may influence baseline symptom scores (such as nasal decongestants)
...
The subject has had common cold or flu like symptoms for more than seven days
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 recently taken a common cold medicine that in the opinion of the investigator may influence baseline symptom scores (such as nasal decongestants)
The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
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 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.
The subject has a history of alcohol or other substance abuse in previous year
The subject is pregnant or lactating -
The subject is a current smoker (more than 2 cigarettes, pipes, cigars a day)
The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
The subject is related to any study personnel
Have a known hypersensitivity or are allergic to any component of the test product

Summary

Conditions
Nasal Congestion
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

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.

Inclusion Criteria

Subject on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale
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 on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale
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).

Exclusion Criteria

The subject has had common cold or flu like symptoms for more than seven days
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 recently taken a common cold medicine that in the opinion of the investigator may influence baseline symptom scores (such as nasal decongestants)
...
The subject has had common cold or flu like symptoms for more than seven days
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 recently taken a common cold medicine that in the opinion of the investigator may influence baseline symptom scores (such as nasal decongestants)
The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
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 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.
The subject has a history of alcohol or other substance abuse in previous year
The subject is pregnant or lactating -
The subject is a current smoker (more than 2 cigarettes, pipes, cigars a day)
The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
The subject is related to any study personnel
Have a known hypersensitivity or are allergic to any component of the test product

Tracking Information

NCT #
NCT02100605
Collaborators
Not Provided
Investigators
  • Study Director: Ron Eccles, Professor Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University Principal Investigator: Moutaz SM Jawad, MB ChB FRCP Cardiff University, Cardiff school of biosciences
  • Study Director: Ron Eccles, Professor Common Cold Centre & Healthcare Clinical Trials, Cardiff school of biosciences, Cardiff University Moutaz SM Jawad, MB ChB FRCP Cardiff University, Cardiff school of biosciences
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