Upper Resp Tract Infection
Conditions
Keywords
Cough, Upper Respiratory Tract Infection, Levodropropizine, Codeine, Hedera Helix
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.
Interventions
DRUGCodeine
Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days
DRUGLevodropropizine
Levodropropizine 30mg/5ml: 10ml three times per day during 4 days
Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days
DRUGPlacebo
Vitamins: 10ml three times per day during 4 days
Sponsors
UC CHRISTUS
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in cough severity | 4 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 | 48 hours | Change in cough severity and duration measured with the Cough Severity Diary |
| Treatment failure | 4 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 | 48 hours | Number of adverse events |
Countries
Chile
Outcome results
None listed