Early symptoms of common cold Signs and Symptoms Acute nasopharyngitis [common cold]
Conditions
Interventions
Coldamaris Prophylactic gel nasal spray versus matching placebo (saline solution) nasal spray, 3 times a day for 7 day
Sponsors
Marinomed Biotechnologie GmbH (Austria)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of symptom clearance defined as the time period between first and last day with symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Outcome results
None listed