J06
Conditions
Interventions
Group 1: Subjects with productive or dry cough associated with common cold will use the substance-based medical device Iceland Moos Syrup for symptom relief (15 mL orally, up to 3 times daily). Sympto
Sponsors
Kwizda Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Informed consent 2. Men and women aged ? 18 years 3. Common cold at Visit 1 (V1) confirmed by investigator, with an upper respiratory tract infection-associated acute cough and the urge to cough 4. Self-reported onset of common cold max. 3 days prior to V1 5. Jackson cold scale score at V1: ?2 total 6. Acute cough (dry or productive) with 24 hour cough severity > 40 mm on 100 mm visual analogue scale (VAS) at V1 7. Onset of cough at least 1 day prior to V1 8. Having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof 9. Subject has had sufficient nourishment (solid, liquid) before V1, so there will very likely be no need to eat or drink within 1 h before and 1 h after first IMD intake of the Iceland Moss Syrup at V1 10. Readiness and ability to comply with study requirements, in particular: - to use Iceland Moss Syrup as recommended - to avoid the use of any other interventional options for cough and associated symptoms during the study (other than Iceland Moss Syrup) - to fill in the electronic diary (eDiary) - to eat and drink sufficiently prior to 2 hours of subject’s rating in the context of the use of Iceland Moss Syrup on Day 2 and Day 3, so that there will very likely be no need to eat or drink during the time period relevant for the rating on that selected Iceland Moss Syrup use occasion - not to smoke during V1 (at least 1 h before and 1 h after first Iceland Moss Syrup intake) and 1 h before/after the selected occasion of Iceland Moss Syrup intake on Day 2 and Day 3 - willingness not to inhale for symptom relief during the study - willingness to avoid strenuous physical activity (especially during travel activities (e.g. going home) after V1) 11. Women of childbearing potential: - commitment to use contraception methods - self-reportedly not pregnant at V1 12. Readiness not to participate in another clinical study during this study
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to the components of Iceland Moss Syrup (self-reported) 2. Presumed isolated acute bronchitis or bronchitis due to bacterial infection as per investigator's judgement (bronchitis-like symptoms in the context of a common cold are allowed) 3. Chronic respiratory disorder (e.g. asthma, allergic rhinitis, chronic bronchitis, chronic cough, obstructive lung disease) 4. Red flags according to CHEST (Irwin et al., 2018) / DEGAM (Krüger et al., 2021) guidelines 5. History of frequent significant complications in the context of previous common cold episodes (e.g. sinusitis, severe bronchitis) per investigator's judgement 6. History or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject 7. Use of preparations that may influence the study outcome within the last 8 hours before V1 and during the study as per investigator’s judgement (e.g. decongestants, throat treatment, antitussives/expectorants, antibiotics etc); if needed, the following preparations may be considered as acceptable during the study: paracetamol, sea water nose drops or spray; angiotensin-converting enzyme (ACE) inhibitors are allowed at the same dosage as prior to the study 8. Use of systemic cough treatment (e.g. drops or syrup) within last 12 h before V1 and during the study 9. Use of local treatment for cough/sore throat within last 2 h before V1 and during the study 10. Women of childbearing potential: pregnancy or nursing 11. History of or current abuse of drugs, alcohol or medication 12. Participation in another study during the last 30 days prior to V1 13. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-term relief of cough in subjects with productive or dry cough associated with common cold, measured through a Visual Analogue Scale (VAS) one hour before versus one hour after Iceland Moss Syrup use | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-term relief of cough associated with common cold in all subjects, measured through a Visual Analogue Scale (VAS) one hour before versus one hour after Iceland Moss Syrup use, as well as Evaluation of other parameters regarding clinical performance prior and after intake through a 7-point Likert scale (1h before vs. 1h after, various time points after intake) at V1 and on days 2 and 3, as well as evaluation of tolerability and safety parameters of Iceland Moss Syrup during the study | — |
Countries
Germany
Contacts
Public ContactLiana Vismane
analyze & realize GmbH
Outcome results
None listed