Study on Hypertonic Saline Nasal Spray
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- 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).
- 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).
- 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
Exclusion Criteria
- 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 a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
- The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
- ...
- 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 a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
- 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 a current smoker (more than 2 cigarettes, pipes, cigars a day)
- 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 had common cold or flu like symptoms for more than seven days
- Have a known hypersensitivity or are allergic to any component of the test product
- The subject has a history of alcohol or other substance abuse in previous year
- The subject is pregnant or lactating -
- The subject is related to any study personnel
- 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 received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
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 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).
- 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).
- 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
Exclusion Criteria
- 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 a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
- The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
- ...
- 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 a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
- 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 a current smoker (more than 2 cigarettes, pipes, cigars a day)
- 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 had common cold or flu like symptoms for more than seven days
- Have a known hypersensitivity or are allergic to any component of the test product
- The subject has a history of alcohol or other substance abuse in previous year
- The subject is pregnant or lactating -
- The subject is related to any study personnel
- 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 received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
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