Does ColdZyme mouth spray protect athletes against upper respiratory tract infection?
| ISRCTN | ISRCTN18133939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18133939 |
| Secondary identifying numbers | CI110-UoKent |
- Submission date
- 07/09/2022
- Registration date
- 27/09/2022
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Endurance athletes appear to be more susceptible than normal to picking up infections, especially upper respiratory tract infections (URTI). Symptoms such as coughs, colds, sore throat, runny nose etc can last for up to 2 weeks, and inevitably cause disruption to training schedules and competitive performance. For this reason, researchers are interested in treatments that may reduce the risk of such illness/symptoms in athletes. They wish to test whether a mouth spray product (ColdZyme) suggested to ‘block’ the viruses that cause the common cold from attaching to cell surfaces in the respiratory tract, can lower the duration of symptoms and/or the number of reports of upper respiratory illness in endurance athletes.
Who can participate?
Endurance athletes (both males and females) over the age of 18 years with at least 3 years of endurance training history and no existing medical conditions
What does the study involve?
If they agree to take part, participants would be required to complete a health questionnaire to ensure they are suitable for participation, and to sign a consent form. For the duration of the monitoring period (3 months) they would be required to keep a log of all of their exercise training. They will also be required to complete a daily upper respiratory tract infection (URTI) symptom questionnaire. Finally, if they do experience any URTI symptoms, they are asked to take a self-swab from their throat using a swabbing device for later analysis (to detect any viruses or bacteria that are known to cause URTIs).
Participants will be asked to use the product in accordance with manufacturer instructions for routine preventative use and for treatment of any suspected URTI as detailed below:
1. Preventative use: "during periods when you think you may be at increased risk or have increased chances of being exposed to a cold, such as heavy training or competition periods, foreign travel or exposure to infected individuals"
2. Treatment if a URTI does occur, e.g. at the first signs of a cold.
What are the possible benefits and risks of participating?
The product should not cause any side effects or adverse reactions for anybody that is not allergic to any of the ingredients listed in the product. However, if participants experience any adverse response, they are advised to stop use immediately and seek medical advice. This would be reported to the sponsor, manufacturer, and ethics committee for appropriate reporting. Taking the throat swab may cause mild discomfort (e.g. some people find a throat swab either tickly or a bit unpleasant) but this only lasts a few seconds. There are no significant long-term risks from this.
Where is the study run from?
University of Kent (UK)
When is the study starting and how long is it expected to run for?
October 2021 to June 2024
Who is funding the study?
Enzymatica AB (Sweden), the company that produces the product
Who is the main contact?
Prof, Glen Davison, G.Davison@kent.ac.uk
Contact information
Principal Investigator
Chipperfield Building
Canterbury Campus
Canterbury
CT2 7PE
United Kingdom
 ORCID ID |
0000-0003-4340-0074 |
|---|---|
| Phone | +44 (0)1227816927 |
| G.Davison@kent.ac.uk |
Study information
| Study design | Placebo-controlled double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Does ColdZyme® Mouth Spray reduce upper respiratory tract infection incidence or duration in endurance athletes? |
| Study hypothesis | Null1: There will be no difference between treatment and placebo groups on self-report upper respiratory tract infection (URTI) duration. Null2: There will be no difference between treatment and placebo groups on self-report URTI incidence. Alternate1: Self-report URTI duration will be significantly shorter in the treatment group. Alternate2: Self-report URTI incidence will be significantly lower in the treatment group. |
| Ethics approval(s) | Approved 09/12/2021, University of Kent, School of Sport & Exercise Sciences Research Ethics and Advisory Group (REAG; Ingram Building, University of Kent, CT2 7NH, UK; +44 (0)1227 827812; ssesethics@kent.ac.uk), ref: 20_20_21 |
| Condition | Upper respiratory tract infection (URTI) in healthy, free-living athletes |
| Intervention | If they agree to take part, participants would be required to complete a health questionnaire to ensure they are suitable for participation, and to sign a consent form. Randomization: Fully double-blind, randomized design (including random sequence generation, allocation concealment, and blinding of participants and study personnel). This investigation will be conducted in a double-blind randomised manner (block randomisation). Participants will be randomly allocated to a placebo or treatment group (double-blind). The subjects will be randomised at the point of study enrolment. The randomisation list will be provided to the contract manufacturer (not involved in the study) by the responsible person at the University of Kent for the labelling of devices according to the randomisation schedule. The ratio of randomisation between ColdZyme and placebo will be 1:1. Random numbers will be assigned to the subjects in a sequential order based on the time of randomisation at each investigational site (whole blocks will be allocated to each centre). All research staff directly involved in the study will remain blinded throughout. The randomisation list will be concealed from the investigational sites. It will be stored under lock and key until database closure. The investigational devices are identical in appearance, packaging and labelling of the bottle and outer carton, to keep subjects and (blinded) research staff blinded to treatment assignment. Participants will be monitored for 3 months and will only use the product in accordance with manufacturer instructions if they believe they need to do so for one of two reasons: for preventative use (e.g. during periods of increased risk, such as heavy training or competition periods, foreign travel or exposure to infected individuals) and also for treatment (e.g. at first signs of a cold). They then use one dose (two puffs) every 2 hours (minimal gap between doses), up to a maximum of 6 times per day, until symptoms resolve. The primary outcome is upper respiratory tract infection (URTI) symptoms as measured using the Jackson common cold questionnaire. This will be completed daily during the study monitoring period (i.e. 3 months for each participant). For the duration of the monitoring period (3 months) they would be required to keep a log of all of their exercise training. Finally, if they do experience any URTI symptoms, they are asked to take a self-swab from their throat using a swabbing device for later analysis (to detect any viruses or bacteria that are known to cause URTIs). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ColdZyme® Mouth Spray |
| Primary outcome measure | URTI episode duration recorded using the Jackson common cold questionnaire completed daily by participants during the 3-month monitoring period |
| Secondary outcome measures | 1. URTI parameters (number of episodes; severity ratings) recorded using the Jackson common cold questionnaire completed daily by participants during the 3-month monitoring period during their enrolment in the study 2. URTI episodes with swab-confirmed pathogen detection: participants will be instructed to collect a “self-swab” if they experience a URTI episode (self-reported via Jackson questionnaire). They will be required to take a throat swab (at the same time) on days 1, 3, 5 and 7 (where day 1 is the first day that symptoms are present). Samples will be screened for the presence of known URTI-causing pathogens using a commercially-available respiratory pathogen qPCR panel 3. Viral load in pathogen-confirmed URTI: relative viral load will be estimated using the Ct values derived from the qPCR panel, and an internal reference gene, for the pathogen screening mentioned above on days 1, 3, 5 and 7 (where day 1 is the first day that symptoms are present) 4. Training load and absence days (days missed training due to URTI): an exercise training log will be recorded prospectively by participants for all planned physical activity (exercise training) that they take part in. For every session, they will record session duration and overall rating of perceived exertion (RPE), which will be used to estimate the overall training load. If an URTI episode causes them to miss, or adjust their training vs what was planned, they will record this on their log. This will be used to calculate missed (or otherwise affected) training for the duration of the monitoring period (3 months). |
| Overall study start date | 01/10/2021 |
| Overall study end date | 01/06/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total of 88 URTI self-report episodes are needed. It is estimated this will require a sample size of n = 114 but it is dependent on incidence rate (i.e. number of episodes per person) during the study period. It may be higher or lower if the incidence rate is low or high, respectively. |
| Participant inclusion criteria | Endurance-trained, competitive athletes (e.g. long-distance runners, triathletes, cyclists), with a high training load (i.e. >5 hours planned training and/or activity per week) |
| Participant exclusion criteria | 1. On long-term medication 2. Currently smoking 3. Allergic to any of the ingredients in ColdZyme 4. Currently using any medication (except for contraceptives), or food supplements 5. Currently using any other relevant products or supplements (nutritional or otherwise) that may influence the common cold 6. Currently taking part in another study that may compromise the results of this study 7. Currently pregnant, breast-feeding or planning to become pregnant during the study |
| Recruitment start date | 01/10/2022 |
| Recruitment end date | 01/02/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Chipperfield Building
Canterbury
CT2 7PE
United Kingdom
Derby
DE22 1GB
United Kingdom
NE2 4DR
United Kingdom
Sponsor information
University/education
Giles Lane
Canterbury
CT2 7NZ
England
United Kingdom
| Phone | +44 (0)1227764000 |
|---|---|
| researchculture@kent.ac.uk | |
| Website | https://www.kent.ac.uk |
"ROR" |
https://ror.org/00xkeyj56 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | The study will be submitted for consideration for publication in relevant peer-reviewed scientific journals after completion. It may also be presented at scientific conferences and other relevant meetings/symposia etc. |
| IPD sharing plan | Depending on the measure, raw data will either be available on request, deposited in an institutional repository, and/or made available with the final publication in a peer-reviewed journal (e.g. as a supplement). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/12/2024 | No | No | ||
| Dataset | 17/12/2024 | 03/03/2025 | No | No | |
| Results article | 28/02/2025 | 03/03/2025 | Yes | No |
Additional files
Editorial Notes
03/03/2025: Publication reference and dataset added.
16/12/2024: The basic results were updated with a new version due to errors in previous versions.
05/09/2024: The basic results (primary and secondary) have been uploaded as an additional file.
15/08/2024: The basic results (primary) have been uploaded as an additional file.
02/02/2024: Newcastle University was added as a study participating centre.
20/11/2023: The sponsor contact email has been changed.
28/09/2023: The University of Derby was added as a study participating centre.
15/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/02/2023 to 01/02/2024.
2. The overall trial end date was changed from 01/06/2023 to 01/06/2024.
3. The intention to publish date was changed from 01/08/2023 to 01/08/2024.
09/09/2022: Trial's existence confirmed by the University of Kent, School of Sport & Exercise Sciences Research Ethics and Advisory Group (REAG).
