Status:
COMPLETED
CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Collaborating Sponsors:
UC CHRISTUS
Conditions:
Upper Resp Tract Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Upper respiratory tract infections affect millions globally, with cough being one of the most bothersome symptoms. While various treatments exist, their comparative effectiveness remains unclear. This...
Eligibility Criteria
Inclusion
- Have between 18 and 65 years of age.
- Have an URTI with Jackson Score ≥6 points.
- Have moderate or severe cough assessed by having a score ≥2 points in the cough domain of the Jackson Score and ≥60mm on the cough visual analogue scale (VAS).
- Have initiated cough within 5 days of enrollment.
- Be capable of understanding and complying with study procedures.
- Sign a written informed consent.
Exclusion
- Physician considers that potential participant needs or might need to use antibiotics at the screening visit (e.g., suspected bacterial otitis, bacterial tonsilitis, bacterial sinusitis, bacterial bronchitis, or bacterial pneumonia) or suspected need for antibiotics during patient follow-up.
- Individuals with pre-existing respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or any chronic lower respiratory tract disease.
- Uncontrolled cardiovascular condition (hypertension, diabetes, etc.)
- Contraindications to use Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Ivy Leaf (Hedera Helix Extract), including Fructose Intolerance, Bronchorrhea, Kartagener Syndrome, Ciliary Dyskinesia, Respiratory Failure, Bronchial Obstructive Syndrome, severe Hypertension, Peptic Ulcer, using Monoamine Oxidase Inhibitors (MAOIs), CYP2D6 ultra-fast metabolizers.
- Pregnancy, suspected pregnancy, desired pregnancy, or breastfeeding.
- Contraindications to the study medications will also result in exclusion, including known or suspected allergies to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
- Known adverse reactions to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
- Participants currently using medications that could interfere with study outcomes, such as other cough suppressants, inhalers, or systemic corticosteroids.
- Researcher considers participant might not comply with study procedures.
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06907355
Start Date
May 13 2025
End Date
December 1 2025
Last Update
December 3 2025
Active Locations (1)
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1
Pontificia Universidad Catolica de Chile
Santiago, Chile