Plain English Summary
Background and study aims:
Upper respiratory tract infection (common cold) is one of most widespread diseases worldwide; however, no effective therapy for this condition has been developed so far.
The aim of this study was to test the hypothesis that treatment with nasal spray containing carrageenan was superior to placebo (saline solution) nasal spray in adult patients with common cold
Who can participate?
Patients could participate if they were of age of 18 years and more and had had early symptoms of common cold
What does the study involve?
All participants received either nasal spray containing carrageenan or saline solution nasal spray which was to be used 3 times daily during one week. During the study period, all patients kept a diary recording either intensity of 8 symptoms (headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough and sneezing) using a 4-point scale or answering a question whether they had any symptoms of common cold. Additionally, at Visits 1 (day 1), 2 (days 3-4) and 3 (days 10-11) nasal fluid was collected. After study end duration of disease, intensity of symptoms over time and viral load in nasal fluid was compared in groups receiving carrageenan spray treatment and placebo.
What are the possible benefits and risks of participating?
There was no immediate benefit for study participants; however, there was possible future benefit for society resulting from development new safe and effective therapy for common cold.
Due to the nature of the condition under study, no significant risks were anticipated.
Where is the study run from?
General Hospital of Vienna
When is study starting and how long is it expected to run for?
The study ran from 4th January, 2010 (first patient enrolled) until 15 June 2011.
Who is funding the study?
Marinomed Biotechnologie GmbH, Vienna, Austria
Who is the main contact?
Marinomed Biotechnologie GmbH
office@marinomed.com
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Carrageenan nasal spray against common cold
Acronym
CANASCOL
Study hypothesis
Primary objective:
To evaluate the effect of the nasal spray on the duration of symptom clearance of common cold compared to placebo treatment
Secondary objectives:
1. To evaluate the effect of the nasal spray on the duration of disease of a common cold defined as the time period between first and last day with symptoms (symptom score > 0) followed by 48 hours without symptoms
2. To evaluate the effect of the nasal spray on the severity of symptoms of common cold compared to placebo
3. To evaluate the effect of the nasal spray compared to placebo treatment with respect to symptom-free days during the observation period of 21 days
4. To evaluate the effect of the nasal spray compared to placebo treatment with respect to the use of co-medication between days 8 - 21 (after finishing the treatment with the carrageenan nasal spray)
5. To evaluate the effect of the nasal spray compared to placebo treatment with respect to the number of newly acquired viral co-infections
6. To investigate the effects of the nasal spray on the presence of biomarkers and common cold viruses in nasal secreted fluid samples
Ethics approval(s)
Medical University of Vienna General Hospital Ethics Committee, 17 November 2009 ref: 879-2009
Study design
Randomised double-blind two-centre parallel group placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Treatment
Patient information sheet
Not available in web format, please contact Marinomed Biotechnologie GmbH (office@marinomed.com) to request a patient information sheet
Condition
Early symptoms of common cold
Intervention
Coldamaris Prophylactic gel nasal spray versus matching placebo (saline solution) nasal spray, 3 times a day for 7 day
Intervention type
Other
Primary outcome measure
Duration of symptom clearance defined as the time period between first and last day with symptoms
Secondary outcome measures
1. The duration of disease being defined as the time period between first and last day with symptoms (symptom score > 0) followed by 48 hours without symptoms
2. Total symptom score (TSS) (Sum of 8 symptoms)
3. Systemic symptom scores on separate study days
4. Local symptom scores on separate study days
5. Individual symptom scores on separate study days
6. Number of days without symptoms during the observation period
7. Consumption of medication (additional to study treatment) during the study period
8. Number of newly acquired viral infections during the observation period
9. Identification of virus, determination of viral titers in nasal secreted fluid
10. Determination of newly acquired or resolved infections
11. Determination of the concentration of cytokines using a Multiplex array
12. Subject acceptability assessments: subjects opinion of the study product / subjects willingness to use the product in the future
Overall study start date
04/01/2010
Overall study end date
15/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients eligible for inclusion in this study had to fulfil all of the following criteria:
1. Age ≥18 years
2. Patients have given informed consent, and received a copy of signed consent form prior to any study related procedures
3. Symptoms of URTI (Upper respiratory tract infection), such as rhinitis/nasal obstruction/sneezing or cough or sore throat or otitis
4. Subjects consider that they are in an early stage of a common cold with symptoms of no more than 48 hours duration
5. Subjects have a symptom score of at least 2 and no more than 9 of sum of severity scores on entry to the study. The score is calculated by summing 8 symptom scores (headache, malaise, chill, sore throat, nasal obstruction, nasal discharge, cough, and sneezing) with each item rated 0=absent, 1=mild, 2=moderate, 3=severe.
6. Subjects agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through Day 7
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
200
Participant exclusion criteria
A patient had not to be recruited in this study if at least one single criterion of the subsequent list was fulfilled:
1. No informed consent
2. Known hypersensitivity or allergy to any component of the test product
3. Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion
4. Proven hypersensitivity of allergy resulting in hayfever and rhinitis
5. Severe nasal septal deviation or other non-infectious condition that could cause nasal obstruction
6. A history of any nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
7. Currrent medication other than oral contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids or intranasal medication
8. Recent treatment of common cold that in the opinion of the investigator may influence symptom scores
9. An unrelated infection that in the opinion of the investigator may influence the symptom scores (gastrointestinal infection, other viral diseases such as measles, mumps)
10. The subject is related to any study personnel, or has any other close ties or conflicts of interest with the research team or the study sponsor
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 has a clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions include immune deficiency, autoimmune disease, substantive cardiovascular, endocrinological, neurological, respiratory, or gastrointestinal disease
13. A history of allergic rhinitis with current eye or nose itching or sneezing, chronic obstructive pulmonary disease with current cough were also the exclusions
Recruitment start date
04/01/2010
Recruitment end date
15/06/2011
Locations
Countries of recruitment
Austria
Study participating centre
Medical University of Vienna General Hospital
Vienna
1090
Austria
Sponsor information
Organisation
Marinomed Biotechnologie GmbH (Austria)
Sponsor details
Veterinärplatz 1
Vienna
1210
Austria
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Marinomed Biotechnologie GmbH (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/11/2013 | Yes | No |