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

NCT06907355 | Completed Phase 4

• 1 other identifier: 241001007
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Upper Resp Tract Infection

Keywords

Cough; Upper Respiratory Tract Infection; Levodropropizine; Codeine; Hedera Helix

Outcome Measures

Primary Outcomes (1)

• Change in cough severity

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

  48 hours

Secondary Outcomes (10)

• Change in cough severity

  4 days

• Change in cough severity

  10 days

• Change in cough severity and duration

  48 hours

• Change in cough severity and duration

  4 days

• Change in cough severity and duration

  10 days

Study Arms (4)

Levodropropizine

EXPERIMENTAL

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

Drug: Levodropropizine

Codeine

EXPERIMENTAL

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

Drug: Codeine

Ivy Leaf (Hedera Helix Extract)

EXPERIMENTAL

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

Drug: Ivy Leaves Cough Liquid

Placebo

PLACEBO COMPARATOR

Vitamins: 10ml three times per day during 4 days

Drug: Placebo

Interventions

Ivy Leaves Cough Liquid DRUG

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

Ivy Leaf (Hedera Helix Extract)

Codeine DRUG

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

Codeine

Levodropropizine DRUG

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

Levodropropizine

Placebo DRUG

Vitamins: 10ml three times per day during 4 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UC CHRISTUS: collaborator
• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Cough

Interventions

Codeine; dipropizine

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 13, 2025
• Primary Completion: November 22, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

CL (1)