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

Phase 4

Not yet recruiting

• Conditions: Upper Resp Tract Infection
• Interventions: Drug: Levodropropizine; Drug: Codeine; Drug: Ivy Leaves Cough Liquid; Drug: Placebo

• Registration Number: NCT06907355
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Status Verified: 2025-04
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Study Start: 2025-04-15
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Have between 18 and 65 years of age.
2. Have an URTI with Jackson Score ≥6 points. [17]
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 URTI symptoms within 72 hours 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levodropropizine	Levodropropizine	Levodropropizine 30mg/5ml: 10ml three times per day during 4 days
Codeine	Codeine	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 Leaves Cough Liquid	Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days
Placebo	Placebo	Vitamins: 10ml three times per day during 4 days

Primary Outcome Measures

Name	Time	Method
Change in cough severity	48 hours	Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)

Secondary Outcome Measures

Name	Time	Method
Change in cough severity	10 days	Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Change in cough severity and duration	10 days	Change in cough severity and duration measured with the Cough Severity Diary
Treatment failure	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)
Treatment safety	10 days	Number of adverse events

Trial Locations

Locations (1)

Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Chile