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

NCT ID: NCT06907355

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2025-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Levodropropizine

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

Group Type: EXPERIMENTAL

Levodropropizine

Intervention Type: DRUG

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

Codeine

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

Group Type: EXPERIMENTAL

Codeine

Intervention Type: DRUG

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

Ivy Leaf (Hedera Helix Extract)

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

Group Type: EXPERIMENTAL

Ivy Leaves Cough Liquid

Intervention Type: DRUG

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

Placebo

Vitamins: 10ml three times per day during 4 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vitamins: 10ml three times per day during 4 days

Interventions

Codeine

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

Intervention Type: DRUG

Levodropropizine

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

Intervention Type: DRUG

Ivy Leaves Cough Liquid

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

Intervention Type: DRUG

Placebo

Vitamins: 10ml three times per day during 4 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UC CHRISTUS

UNKNOWN

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Diego Garcia Huidobro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pontificia Universidad Catolica de Chile

Santiago, , Chile

Countries

Chile

Other Identifiers

241001007

Identifier Type: -

Identifier Source: org_study_id