Clinical trial NCT06907355: CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Upper Resp Tract Infection
Keywords: Cough
Upper Respiratory Tract Infection
Levodropropizine
Codeine
Hedera Helix
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: UC CHRISTUS
First posted: 2025-04-02
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in cough severity
timeFrame: 48 hours
Secondary outcomes:
measure: Change in cough severity
timeFrame: 4 days
measure: Change in cough severity
timeFrame: 10 days
measure: Change in cough severity and duration
timeFrame: 48 hours
measure: Change in cough severity and duration
timeFrame: 4 days
measure: Change in cough severity and duration
timeFrame: 10 days
measure: Treatment failure
timeFrame: 4 days
measure: Treatment failure
timeFrame: 10 days
measure: Treatment safety
timeFrame: 48 hours
measure: Treatment safety
timeFrame: 4 days
measure: Treatment safety
timeFrame: 10 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
Study officials:
References: