CoughPhase 3LDP0114NCT03837938
Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough
A Phase 3 study testing Levopront® syrup 30 mg/5 ml and Libexin® in people with Cough, run by Dompé Farmaceutici S.p.A at 8 sites in Russia.
Trial summary
Primary objective: To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8. The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale". Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cough
- What is being tested?
- Levopront® syrup 30 mg/5 ml and Libexin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 8 sitesRussia
- Study dates
- 9 Nov 2016to 31 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects should meet the following inclusion criteria to be included into this clinical trial:
- Signed Informed Consent Form
- Male or female aged from 18 to 65 (inclusive)
- Dry non-productive cough as a symptom of acute upper respiratory infection (IDC codes J00-J06)
- Daytime cough symptom score ≥ 3 points according to the "Six-point daytime and nighttime cough assessment scale"
- Pre-bronchodilator FEV1 ≥ 70% of the predicted values, post-bronchodilator FEV1 increase of ≤ 12% or ≤ 200 ml compared to the baseline, FEV1/FVC (Tiffeneau index) ≥ 0.7
Show all 11Show fewer
- Patient's consent to follow the protocol procedures, including the completion of the patient's diary
- Patient's consent to use the adequate contraception methods throughout the study period. The adequate birth control methods are as follows:
- Oral or transdermal contraceptives
- Condoms or diaphragms (barrier method) with spermicide
- Intrauterine contraceptive devices
Who cannot join
- Subjects with any of the following conditions will be excluded from the study:
- Hypersensitivity or individual contraindications to Levodropropizine, Prenoxdiazine or additives of the study drug
- Hereditary fructose intolerance, glucose-lactose malabsorption, lactase deficiency, sucrose-isomaltose deficiency
- Tuberculosis, bronchial asthma, malignant tumors of lungs or bronchi, COPD, severe respiratory failure (cyanosis, need for respiratory support) or other lung pathology at screening or in history
- Inhalation anesthesia within 3 months before screening
- Smoking history of more than 10 pack-years
Show all 19Show fewer
- Previous use of cough medicines, ACE inhibitors or amiodarone within 30 days before screening
- Contraindications or inability to perform spirometry
- Necessity (in the Investigator's opinion) of prescribing mucolytic agents, expectorants, antibiotics or other medications prohibited by the protocol during the study
- Excessive mucous excretion which (in the Investigator's opinion) could be a contraindication to prescribing anti-cough medicines; decreased mucociliary function (Kartagener's syndrome, ciliary dyskinesia)
- Malignant tumors in the past 5 years (except for the basal cell carcinoma)
- Serious cardiovascular disease at the moment or within 12 months prior to screening, including: Chronic heart failure class III or IV (according to the classification of the New York Heart Association), severe arrhythmias requiring treatment with antiarrhythmic drugs class Ia, Ib, Ic or III, unstable angina, myocardial infarction, heart surgery and coronary arteries, serious valvular heart disease, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure > 180 mmHg and diastolic blood pressure > 110 mmHg, pulmonary embolism or deep vein thrombosis
- Gastric or duodenal ulcers, gastroesophageal reflux disease within a period of 12 months before screening
- Systemic autoimmune disorders and connective tissue diseases that require (currently or previously) administration of systemic glucocorticosteroids, cytostatic medications or penicillamine
- Signs of intensive non-controlled concurrent disease, including disorders of the nervous system, endocrine system, kidneys, liver or gastrointestinal tract, which (in the Investigator's opinion) could prevent the patient's participation in the study
- History of alcohol or drug abuse at screening or in the past, which results in the inability of the patient to participate in the study at the Investigator's discretion
- Taking part in another clinical trial or use of study drug within 30 days before screening
- Pregnant or breast-feeding women or women planning pregnancy during the clinical trial; women of childbearing potential (including not sterilized operatively and in postmenopausal period of less than 2 years), not using appropriate methods of contraception
- Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; violation of the drug administration regimen or procedure execution that, at the discretion of the Investigator, can impact he results of the study or safety of the patient and interfere his further participation in the study; any other concomitant medical or serious mental conditions that make the patient unsuitable for participation in the clinical study, limit the validity of receiving an informed consent or may affect the patient's ability to participate in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
State Public Healthcare Institution of Moscow "City Clinical Hospital # 71 of Moscow Healthcare Department"
Moscow, 121374
The Laboratory of Pulmonology, State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical-Stomatological University n.a. A.I. Evdokimov" under Ministry of Health of the Russian Federation (Clinical base of state budget
Moscow, 127473
State Budgetary Educational Institution of Higher Professional Education "Ryazan' State Medical University n.a. academician I.P. Pavlov" under Ministry of Health of the Russian Federation
Ryazan, 390026
"Institute of Medical Research" LLC
Saint Petersburg, 196084
Saint-Petersburg State Healthcare Institution "Nikolaevskaya Hospital"
Saint Petersburg, 198510
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053
LLC Treatment-and-prophylactic institution on the "Smolensk clinic"
Smolensk, 214016
State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"
Yaroslavl, 150003
About this study
Official title: Multicenter Open-label Randomized Clinical Trial of the Efficacy and Safety of Levopront® Syrup 30 mg/5 ml in Comparison With Libexin® 100 mg Tablets in Patients With Dry Non-productive Cough Caused by Acute Upper Respiratory Infection
Primary objective:
To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8.
Read more
The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale".
Secondary objectives:
Treatment effect assessment in terms of the following efficacy and safety parameters:
- To assess the efficacy of Levopront® in comparison with Libexin® based on nighttime cough resolution rate by Day 8.
- Daytime and nighttime cough symptoms resolution according to "Six-point daytime and nighttime cough assessment scale" by Day 4.
- Change in severity and frequency of daytime and nighttime cough according to "Six-point daytime and nighttime cough assessment scale" on Day 4 and Day 8 from baseline on Day 1.
- Cough intensity change according to the visual-analogue scale on Day 4 and Day 8 from baseline on Day 1.
- Change of FEV1 on Day 8 from baseline values on Day 1.
- Rate of Adverse events (AE) and Serious Adverse Events (SAE) of the various severity according to subjective complaints, laboratory test results, physical examination, vital signs and spirometry
Read the detailed description
This is a multicenter, open-label, randomized, clinical trial to assess the efficacy and safety of Levopront® syrup 30 mg/5 ml in comparison with Libexin® 100 mg tablets in patients suffering from dry non-productive cough caused by acute upper respiratory infection
- Conditions
- Cough
- Being tested
- Levopront® syrup 30 mg/5 ml, Libexin®
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levopront® syrup 30 mg/5 mlDrug
Also called levodropropizine
The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).
Libexin®Drug
Also called prenoxdiazine
The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
| Study group | Role | What they receive |
|---|---|---|
| Levopront® syrup 30 mg/5 ml | Experimental | Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Receives: Drug: Levopront® syrup 30 mg/5 ml |
| Libexin® 100 mg tablets | Active comparator | Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Receives: Drug: Libexin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population
Daytime cough (>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome.
The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
Measured: At Visit 3, Day 8
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population
Daytime cough (>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome.
The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
Measured: At Visit 3, Day 8
Secondary outcomes (6)
Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population
Night-time cough ( >22:00 h up to 08:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the night to 5 = distressing coughs preventing any sleep. The nighttime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome.
The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
Measured: At Visit 3, Day 8
Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population
Daytime cough ( >08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale) where 0 = no cough during the day to 5 = distressing coughs most of the day. Night-time cough ( >22:00 h up to 08:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale) where 0 = no cough during the night to 5 = distressing coughs preventing any sleep.
The (daytime and nighttime) cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome.
The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 4 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
Measured: At Visit 2, Day 4
Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population
Daytime cough ( >08:00 h up to 22:00 h) evaluated on a 6-point scale: 0 = no cough during the day to 5 = distressing coughs most of the day.
Night-time cough ( >22:00 h up to 08:00 h) evaluated on a 6-point scale: 0 = no cough during the night to 5 = distressing coughs preventing any sleep.
Measured: Baseline, At visit 2 Day 4; at visit 3, Day 8
Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population.
The visual-analogue scale (VAS) is a 100 mm scale which ranges from 'no cough' (0 mm) to 'the worst cough severity' (100 mm). The higher the score, the worse the outcome.
Measured: Baseline, At visit 2 (Day 4); at visit 3 (Day 8)
Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population.
FEV1 is the Forced Expiratory Volume (in liters) in 1 second. The higher the value, the better the outcome.
Measured: At Visit 3 (Day 8)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints
Adverse Event (AE) - any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, complaint or disorder.
Serious Adverse Event (SAE) - Any adverse medical event which, irrespective of the dose of the study drug:
- results in death;
- is life-threatening;
- requires hospitalization (initial or prolonged);
- results in significant, persistent or permanent impairment or disability; or
- is a congenital anomaly or birth defect
- is an important medical event that may be not immediately life threatening or result in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in the definition above.
Measured: From the moment of signing Informed Consent Form (prior to administration of the first dose of the study drug) to Day 30 after the last visit of the patient or last procedure per protocol, up to day 10"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start9 Nov 2016
- Primary completion6 Mar 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoughStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Federico Saibene, MD, Study director, Dompé SpA Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837938
- Sponsor's protocol ID
- LDP0114
- Acronym
- LDP0114
- Status last verified
- Oct 2023
- First submitted
- 28 Jan 2019
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open-label Randomized Clinical Trial of the Efficacy and Safety of Levopront® Syrup 30 mg/5 ml in Comparison With Libexin® 100 mg Tablets in Patients With Dry Non-productive Cough Caused by Acute Upper Respiratory Infection
- ClinicalTrials.gov ID
- NCT03837938
- Acronym / sponsor ID
- LDP0114 / LDP0114
- Conditions
- Cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 15 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8.
The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale".
Secondary objectives:
Treatment effect assessment in terms of the following efficacy and safety parameters:
- To assess the efficacy of Levopront® in comparison with Libexin® based on nighttime cough resolution rate by Day 8.
- Daytime and nighttime cough symptoms resolution according to "Six-point daytime and nighttime cough assessment scale" by Day 4.
- Change in severity and frequency of daytime and nighttime cough according to "Six-point daytime and nighttime cough assessment scale" on Day 4 and Day 8 from baseline on Day 1.
- Cough intensity change according to the visual-analogue scale on Day 4 and Day 8 from baseline on Day 1.
- Change of FEV1 on Day 8 from baseline values on Day 1.
- Rate of Adverse events (AE) and Serious Adverse Events (SAE) of the various severity according to subjective complaints, laboratory test results, physical examination, vital signs and spirometry
Detailed description
This is a multicenter, open-label, randomized, clinical trial to assess the efficacy and safety of Levopront® syrup 30 mg/5 ml in comparison with Libexin® 100 mg tablets in patients suffering from dry non-productive cough caused by acute upper respiratory infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levopront® syrup 30 mg/5 ml | Experimental | Drug: Levopront® syrup 30 mg/5 mlLevopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. |
| Libexin® 100 mg tablets | Active comparator | Drug: Libexin®Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects should meet the following inclusion criteria to be included into this clinical trial:
- Signed Informed Consent Form
- Male or female aged from 18 to 65 (inclusive)
- Dry non-productive cough as a symptom of acute upper respiratory infection (IDC codes J00-J06)
- Daytime cough symptom score ≥ 3 points according to the "Six-point daytime and nighttime cough assessment scale"
Key exclusion criteria (19 listed)
- Hypersensitivity or individual contraindications to Levodropropizine, Prenoxdiazine or additives of the study drug
- Hereditary fructose intolerance, glucose-lactose malabsorption, lactase deficiency, sucrose-isomaltose deficiency
- Tuberculosis, bronchial asthma, malignant tumors of lungs or bronchi, COPD, severe respiratory failure (cyanosis, need for respiratory support) or other lung pathology at screening or in history
- Inhalation anesthesia within 3 months before screening
- Smoking history of more than 10 pack-years
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 |
|---|---|---|
| Levopront® syrup 30 mg/5 mlAlso: levodropropizineThe first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). | Drug | Levopront® syrup 30 mg/5 ml |
| Libexin®Also: prenoxdiazineThe first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing. | Drug | Libexin® 100 mg tablets |
Primary outcome
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population
Time frame: At Visit 3, Day 8
Daytime cough (>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population
Time frame: At Visit 3, Day 8
Daytime cough (>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.
6 secondary outcomes
Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population
Time frame: At Visit 3, Day 8
Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population
Time frame: At Visit 2, Day 4
Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population
Time frame: Baseline, At visit 2 Day 4; at visit 3, Day 8
Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population.
Time frame: Baseline, At visit 2 (Day 4); at visit 3 (Day 8)
Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population.
Time frame: At Visit 3 (Day 8)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints
Time frame: From the moment of signing Informed Consent Form (prior to administration of the first dose of the study drug) to Day 30 after the last visit of the patient or last procedure per protocol, up to day 10"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Federico Saibene, MD study director
Dompé SpA Milan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levopront® syrup 30 mg/5 ml and Libexin® in people with Cough, run by Dompé Farmaceutici S.p.A at 8 sites in Russia.
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 11 inclusion and 19 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population (time frame: At Visit 3, Day 8). The study lists 2 primary outcomes in all. 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 16 Apr 2024.