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OpenTrials
Completed

NCT Number: NCT06907355

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

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 study aims to evaluate and compare three commonly used treatments for acute cough in adults with upper respiratory tract infections: Levodropropizine, Codeine (with Pseudoephedrine and Chlorphenamine), and Ivy Leaf (Hedera Helix Extract). Investigators will conduct a double-blind, parallel-group randomized clinical trial with 184 adults aged 18-65 with acute upper respiratory tract infection and moderate to severe cough. Participants will be randomized to receive Levodropropizine, Codeine + Pseudoephedrine + Chlorphenamine, Ivy Leaf, or Placebo three times a day for 4 days. The primary outcome is cough severity at 48 hours, measured by a cough numerical rating scale. Secondary outcomes include cough severity and duration at 4- and 10-days. This trial will provide high-quality evidence comparing the efficacy of three widely used antitussive medications in primary care settings. The results could help establish evidence-based guidelines for treating acute cough in upper respiratory infections.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pontificia Universidad Catolica de Chile

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Codeine

Drug

Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days

Levodropropizine

Drug

Levodropropizine 30mg/5ml: 10ml three times per day during 4 days

Ivy Leaves Cough Liquid

Drug

Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days

Placebo

Drug

Vitamins: 10ml three times per day during 4 days

Primary outcomes

  1. Change in cough severity

    Time frame: 48 hours

    Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)

Secondary outcomes

  1. Change in cough severity

    Time frame: 4 days

    Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)

  2. Change in cough severity

    Time frame: 10 days

    Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)

  3. Change in cough severity and duration

    Time frame: 48 hours

    Change in cough severity and duration measured with the Cough Severity Diary

  4. Change in cough severity and duration

    Time frame: 4 days

    Change in cough severity and duration measured with the Cough Severity Diary

  5. Change in cough severity and duration

    Time frame: 10 days

    Change in cough severity and duration measured with the Cough Severity Diary

  6. Treatment failure

    Time frame: 4 days

    Categorical outcome:

    Yes: Persisting with a score ≥6 in the cough numerical rating scale (0-10) No: Not having cough or persisting with a score <6 in the cough numerical rating scale (0-10)

  7. Treatment failure

    Time frame: 10 days

    Categorical outcome:

    Yes: Persisting with a score ≥6 in the cough numerical rating scale (0-10) No: Not having cough or persisting with a score <6 in the cough numerical rating scale (0-10)

  8. Treatment safety

    Time frame: 48 hours

    Number of adverse events

  9. Treatment safety

    Time frame: 4 days

    Number of adverse events

  10. Treatment safety

    Time frame: 10 days

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • UC CHRISTUS

Registry information

Official study title

A Double-Blind Randomized Clinical Trial Comparing Levodropropizine, Codeine, Ivy Leaf (Hedera Helix Extract), and Placebo for the Treatment of Acute Cough in Adults With Upper Respiratory Tract Infections in Primary Care

Acronym: CHAO TOS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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