Pontificia Universidad Catolica de Chile
Santiago, Chile
NCT Number: NCT06907355
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Santiago, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days
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
Vitamins: 10ml three times per day during 4 days
Time frame: 48 hours
Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)
Time frame: 4 days
Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Time frame: 10 days
Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Time frame: 48 hours
Change in cough severity and duration measured with the Cough Severity Diary
Time frame: 4 days
Change in cough severity and duration measured with the Cough Severity Diary
Time frame: 10 days
Change in cough severity and duration measured with the Cough Severity Diary
Time frame: 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)
Time frame: 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)
Time frame: 48 hours
Number of adverse events
Time frame: 4 days
Number of adverse events
Time frame: 10 days
Number of adverse events
Pontificia Universidad Catolica de Chile
Other
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
Acronym: CHAO TOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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