CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS

Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Mar 26, 2025

Keywords

ClinConnect Summary

The CHAO Tos trial is a study designed to compare three different treatments for cough caused by upper respiratory tract infections, which are common and can be quite bothersome. The treatments being tested are Levodropropizine, a combination of Codeine with Pseudoephedrine and Chlorphenamine, and Ivy Leaf extract. The trial will involve 184 adults aged 18 to 65 who have moderate to severe cough and have started showing symptoms within the last 72 hours. Participants will be randomly assigned to receive one of the treatments or a placebo (a sugar pill) three times a day for four days. The main goal is to see how well these treatments reduce cough severity after 48 hours.

To join this trial, participants must be between 18 and 65 years old and have a cough that is moderate to severe. Certain health conditions, such as serious respiratory issues or uncontrolled heart problems, may prevent someone from participating. Throughout the trial, participants will be monitored closely, and their cough severity will be measured at different points. This study aims to provide valuable information that could help doctors decide the best way to treat coughs in patients with upper respiratory infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have between 18 and 65 years of age.
• • 2. Have an URTI with Jackson Score ≥6 points.
• • 3. 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).
• • 4. Have initiated cough within 5 days of enrollment.
• • 5. Be capable of understanding and complying with study procedures.
• • 6. Sign a written informed consent.
• Exclusion Criteria:
• • 1. 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.
• • 2. Individuals with pre-existing respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or any chronic lower respiratory tract disease.
• • 3. Uncontrolled cardiovascular condition (hypertension, diabetes, etc.)
• • 4. 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.
• • 5. Pregnancy, suspected pregnancy, desired pregnancy, or breastfeeding.
• • 6. Contraindications to the study medications will also result in exclusion, including known or suspected allergies to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
• • 7. Known adverse reactions to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
• • 8. Participants currently using medications that could interfere with study outcomes, such as other cough suppressants, inhalers, or systemic corticosteroids.
• • 9. Researcher considers participant might not comply with study procedures.