The effect of early administered cineole on the course of a common cold
- Conditions
- common coldMedDRA version: 22.1Level: LLTClassification code 10010106Term: Common coldSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-000860-51-DE
- Lead Sponsor
- Cassella-med GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Visit 1 – Screening
1.Age between 18 and 70 years
2.Recollecting having =1 common cold in the last winter season by asking the subject
3.Informed consent, personally dated and signed by the subject and the investigator, and data protection declaration
4.Willingness and ability to use an eDiary
5.Availability of an appropriate device for eDiary data entry, i.e. smartphone, tablet or computer
6.Subject able to follow the instructions given by the investigator
Visit 2 – Inclusion diagnosis, start of treatment
7.Start of eDiary documentation =48 hours before first IMP intake
8.Common cold with or without bronchitis clinically diagnosed by the investigator
9.Yes” to the question Does it feel to you that you are developing a cold or that you have a cold?”
10.Using Jackson’s criteria, subjects have to report at least a sum score of = 3 in up to the four cold symptoms:
Nasal discharge
Nasal obstruction
Sneezing
Sore throat
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Visit 1 – Screening
1.Any known chronic ear, nose, throat and respiratory tract disease or any other known serious disease that can influence the course of the common cold, e.g. chronic bronchitis (WHO Definition), chronic obstructive pulmonary disease (COPD), bronchial asthma, chronic active allergic rhinitis (e.g. dust mite allergy), chronic rhinosinusitis with or without nasal polyp(s), cystic fibrosis within the past 2 years before Visit 1
2.Pneumonia, pertussis and / or pseudo-croup
3.Long-term treatment (>14 days) with systemically administered antibiotics within the last 7 days before Visit 1
4.Previous SARS-CoV-2 infection confirmed by RT-PCR (based on medical history)
5.Known hypersensitivity to cineole or any of the other compounds of Soledum® forte capsules
6.Known hereditary fructose intolerance
7.Presence of clinically relevant renal and / or liver diseases
8.Any respiratory disease or symptoms related to smoking: asymptomatic smokers are allowed to be included
9.Presence of immunosuppressive state, malignancy (actual, condition after carcinoma less than 2 years without relapse), autoimmune disease(s), AIDS
10.Pregnancy (positive urine pregnancy test) or lactation
11.Female of childbearing potential without medically accepted contraception
12.History or presence of dependency from alcohol or drugs
13.Participation in another clinical study, already terminated or still ongoing, within the last 30 days
14.Known to be, or suspected of being unable to comply with the trial protocol (e.g., no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
15.Legal incapacity and / or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial
16.Subject in custody by juridical or official order
17.Subject who has difficulties in understanding the language (German) in which the subject information (informed consent form) is given
18.Subjects who are members of the staff of the trial center, staff of the sponsor or the clinical research organization (CRO), the investigator himself or close relatives of the investigator
Visit 2 – Inclusion diagnosis, start of treatment
Same exclusion criteria as for Visit 1 plus the following ones:
19.Start of eDiary documentation longer than 12 h after symptom onset
20.Any known acute ear, nose, throat and respiratory tract disease that can influence the course of the common cold e.g. assured diagnosis of the flu, Covid-19 (acute or previous infection since Visit 1), allergic rhinitis (e.g. allergy to a current available seasonal allergen)
21.Hypoxemia, i.e. SpO2 =92%
22.Any complications of the common cold that have to be treated with antibiotics
23.Subjects treated with or need for treatment with antibiotics (systemic), glucocorticosteroids (systemic, per inhalation or nasal), ß2-mimetics, theophylline, common cold or cough medication (systemic, per inhalation or nasal) within 7 days prior to Visit 2 or at the time of Visit 2
24.Regular treatment (i.e. >2 single doses since onset of common cold) with systemic non-steroidal anti-inflammatory drugs [NSAIDs] / analgesics (except low dose acetylsalicylic acid [ASA]) within 7 days prior to Visit 2 or at the time of Visit 2
25.Drugs without marketing authorization or drugs without marketing authorization in the indication they are used for within 7 days prior to Visit 2 or at the time of Visit 2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this clinical trial is to investigate the relation between timing of treatment onset with cineole and course of a common cold with or without acute bronchitis.;Secondary Objective: not applicable;Primary end point(s): Area under the curve global symptom severity (AUC-WURSS):<br>Derivation of AUC-WURSS is based on mean daily total WURSS-11 scores, which are derived by averaging evening assessment of considered day and morning assessment of the subsequent day per item. The mean item scores will then be summarized to the mean total score of a day. For the AUC-WURSS, the mean daily total WURSS-11 scores will be summed across all days using trapezoidal approximation.<br>;Timepoint(s) of evaluation of this end point: daily from symptom onset until end of treatment from diary data
- Secondary Outcome Measures
Name Time Method