An interventional study of Lozenges and Placebo lozenges in Common Cold and Respiratory Tract Infections, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment
A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both participants and investigators blinded.
The zinc lozenge that will be used in the study is a commercial product available from the University Pharmacy, Helsinki, Finland. The product is classified as a "medical device" and it is not regulated according to the jurisdiction for medicines.
Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction in the commercial package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days. The same instruction will be used in this trial.
The University Pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. 200 packages of zinc lozenges will be used as the active intervention. The packages will contain 30 lozenges (6 lozenges/day × 5 days).
The packages of lozenges will be distributed to the enrolled participants in November 2017. The participants will be instructed to keep the package readily available so that, when they catch the common cold, they will find the package and they can start to take the lozenges according to the instructions.
The participants will be instructed to start taking zinc lozenges as soon as they start to suffer from the first symptoms of the common cold. The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible. The duration of intervention is for the maximum of 5 days. If the symptoms disappear before 5 days, the participant may stop the usage of the lozenges.
There will be no limitations for other treatments that participants wish to use for treating their colds.
Participants will be requested to respond to a web-based symptom questionnaire daily from the first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 87 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →University of Helsinki is the lead sponsor of 133 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days, as early as possible from the start of the cold symptoms.
Device: Lozenges
The placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste.
Device: Placebo lozenges
The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible.
Placebo lozenges
The duration of the common cold (time to recovery)
Data of 12 common cold symptoms will be recorded by patients to web-based system, with scale 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe symptom. The symptom score is calculated as a sum over all the symptoms which means that the maximum of the symptom score scale is 3×12 = 36 points. Recovery from the cold is defined as the day when the symptom score is 0 or 1.
Time frame: 2 weeks after the start of the intervention
Objective fever
Measured fever (≥37.5°C any time during the day) (Yes / No)
Time frame: 2 weeks after the start of the intervention
Sickness absence
Data will be collected of the absence from work after the start of intervention
Time frame: About 1 month after the start of the intervention
Usage of antibiotics and/or asthma medication
Data will be collected of the usage of antibiotics and/or asthma medication after the start of intervention
Time frame: About 1 month after the start of the intervention
Complications such as sinusitis, bronchitis, otitis.
Data will be collected of the occurrence of sinusitis, bronchitis, otitis after the start of intervention
Time frame: About 1 month after the start of the intervention
Plan to share: Yes — IPD reported with the trial report (2020)
Time frame: Upon the publication of trial report indefinitely
Access criteria: IPD reported with the trial report (2020) is freely available
Ran from Dec 2017 to primary completion in Apr 2018, 4 months.
Of 49 interventional studies with no phase under Common Cold, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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