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

Pontificia Universidad Catolica de Chile

Status and phase: Not yet enrolling; Phase 4

Conditions: Upper Resp Tract Infection

Treatments: Drug: Levodropropizine; Drug: Ivy Leaves Cough Liquid; Drug: Codeine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06907355

241001007

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 4 patient groups, including a placebo group

Levodropropizine

Experimental group

Description:

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

Treatment:

Drug: Levodropropizine

Codeine

Experimental group

Description:

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

Treatment:

Drug: Codeine

Ivy Leaf (Hedera Helix Extract)

Experimental group

Description:

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

Treatment:

Drug: Ivy Leaves Cough Liquid

Placebo

Placebo Comparator group

Description:

Vitamins: 10ml three times per day during 4 days

Treatment:

Drug: Placebo