Comparing treatments for cough in upper respiratory infections

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

This study is testing three different treatments for bad coughs caused by upper respiratory infections to see which one works best for adults aged 18 to 65.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Pontificia Universidad Catolica de Chile (Academic / other)
• Locations: 1 site (Santiago)
• Trial ID: NCT06907355 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of three treatments for acute cough in adults suffering from upper respiratory tract infections: Levodropropizine, Codeine combined with Pseudoephedrine and Chlorphenamine, and Ivy Leaf extract. The study involves a double-blind, parallel-group randomized design with 184 participants aged 18-65 who have moderate to severe cough. Participants will receive one of the treatments or a placebo three times a day for four days, with cough severity measured at 48 hours and secondary outcomes assessed at four and ten days. The goal is to provide high-quality evidence on the comparative effectiveness of these treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with moderate to severe cough due to an upper respiratory tract infection.

Not a fit: Patients with pre-existing respiratory conditions or those requiring antibiotics for bacterial infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from cough due to upper respiratory infections.

How similar studies have performed: Other studies have explored treatments for cough, but this specific comparison of these three treatments is novel.

Eligibility criteria

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.

Where this trial is running

Santiago

• Pontificia Universidad Catolica de Chile — Santiago, Chile (Recruiting)

Study contacts

• Study coordinator: Diego Garcia-Huidobro, MD, PhD

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