Upper Resp Tract InfectionPhase 4CHAO TOSNCT06907355
CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS
A Phase 4 study testing Codeine, Levodropropizine and Ivy Leaves Cough Liquid in people with Upper Resp Tract Infection, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Resp Tract Infection
- What is being tested?
- Codeine, Levodropropizine and Ivy Leaves Cough Liquid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteChile
- Study dates
- 13 May 2025to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have between 18 and 65 years of age.
- Have an URTI with Jackson Score ≥6 points.
- 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).
- Have initiated cough within 5 days of enrollment.
- Be capable of understanding and complying with study procedures.
- Sign a written informed consent.
Who cannot join
- 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.
- Individuals with pre-existing respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or any chronic lower respiratory tract disease.
- Uncontrolled cardiovascular condition (hypertension, diabetes, etc.)
- 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.
- Pregnancy, suspected pregnancy, desired pregnancy, or breastfeeding.
- Contraindications to the study medications will also result in exclusion, including known or suspected allergies to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
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- Known adverse reactions to Levodropropizine, Codeine, Pseudoephedrine, Chlorphenamine, or Hedera Helix Extract.
- Participants currently using medications that could interfere with study outcomes, such as other cough suppressants, inhalers, or systemic corticosteroids.
- Researcher considers participant might not comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Upper Resp Tract Infection
- Being tested
- Codeine, Levodropropizine, Ivy Leaves Cough Liquid, Placebo
- Keywords
- Cough, Upper Respiratory Tract Infection, Levodropropizine, Codeine, Hedera Helix
- Medical subject headings
- Respiratory Tract Infections, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CodeineDrug
Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days
LevodropropizineDrug
Levodropropizine 30mg/5ml: 10ml three times per day during 4 days
Ivy Leaves Cough LiquidDrug
Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days
PlaceboDrug
Vitamins: 10ml three times per day during 4 days
| Study group | Role | What they receive |
|---|---|---|
| Levodropropizine | Experimental | Levodropropizine 30mg/5ml: 10ml three times per day during 4 days Receives: Drug: Levodropropizine |
| Codeine | Experimental | Codeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days Receives: Drug: Codeine |
| Ivy Leaf (Hedera Helix Extract) | Experimental | Ivy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days Receives: Drug: Ivy Leaves Cough Liquid |
| Placebo | Placebo comparator | Vitamins: 10ml three times per day during 4 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cough severity
Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)
Measured: 48 hours
Secondary outcomes (10)
Change in cough severity
Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Measured: 4 days
Change in cough severity
Change in cough severity measured with the cough numerical rating scale (0-10, higher scores mean higher cough severity)
Measured: 10 days
Change in cough severity and duration
Change in cough severity and duration measured with the Cough Severity Diary
Measured: 48 hours
Change in cough severity and duration
Change in cough severity and duration measured with the Cough Severity Diary
Measured: 4 days
Change in cough severity and duration
Change in cough severity and duration measured with the Cough Severity Diary
Measured: 10 days
Treatment failure
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)
Measured: 4 days
Treatment failure
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)
Measured: 10 days
Treatment safety
Number of adverse events
Measured: 48 hours
Treatment safety
Number of adverse events
Measured: 4 days
Treatment safety
Number of adverse events
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start13 May 2025
- Primary completion22 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Resp Tract InfectionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- UC CHRISTUS
- Responsible party
- Principal investigator, Diego Garcia Huidobro, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907355
- Sponsor's protocol ID
- 241001007
- Acronym
- CHAO TOS
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06907355
- Acronym / sponsor ID
- CHAO TOS / 241001007
- Conditions
- Upper Resp Tract Infection
- Keywords
- Cough, Upper Respiratory Tract Infection, Levodropropizine, Codeine, Hedera Helix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- UC CHRISTUS
- Study start
- 13 May 2025 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levodropropizine | Experimental | Drug: LevodropropizineLevodropropizine 30mg/5ml: 10ml three times per day during 4 days |
| Codeine | Experimental | Drug: CodeineCodeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days |
| Ivy Leaf (Hedera Helix Extract) | Experimental | Drug: Ivy Leaves Cough LiquidIvy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days |
| Placebo | Placebo comparator | Drug: PlaceboVitamins: 10ml three times per day during 4 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have between 18 and 65 years of age.
- Have an URTI with Jackson Score ≥6 points.
- 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).
- Have initiated cough within 5 days of enrollment.
- Be capable of understanding and complying with study procedures.
Key exclusion criteria (9 listed)
- 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.
- Individuals with pre-existing respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or any chronic lower respiratory tract disease.
- Uncontrolled cardiovascular condition (hypertension, diabetes, etc.)
- 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.
- Pregnancy, suspected pregnancy, desired pregnancy, or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CodeineCodeine 10mg/5ml + Pseudoephedrine 7.5mg/5ml + Chlorphenamine 0.5mg/5ml: 10ml three times per day during 4 days | Drug | Codeine |
| LevodropropizineLevodropropizine 30mg/5ml: 10ml three times per day during 4 days | Drug | Levodropropizine |
| Ivy Leaves Cough LiquidIvy Leaf (Hedera Helix Extract) 35 mg/5ml: 10ml three times per day during 4 days | Drug | Ivy Leaf (Hedera Helix Extract) |
| PlaceboVitamins: 10ml three times per day during 4 days | Drug | Placebo |
Primary outcome
Change in cough severity
Time frame: 48 hours
Change in cough severity measured by a cough numerical rating scale (0-10, higher scores mean higher cough severity)
10 secondary outcomes
Change in cough severity
Time frame: 4 days
Change in cough severity
Time frame: 10 days
Change in cough severity and duration
Time frame: 48 hours
Change in cough severity and duration
Time frame: 4 days
Change in cough severity and duration
Time frame: 10 days
Treatment failure
Time frame: 4 days
Treatment failure
Time frame: 10 days
Treatment safety
Time frame: 48 hours
Treatment safety
Time frame: 4 days
Treatment safety
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Codeine, Levodropropizine and Ivy Leaves Cough Liquid in people with Upper Resp Tract Infection, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cough severity (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.