Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough … (NCT05269329) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection
Russia160 participantsStarted 2021-04-26
Plain-language summary
Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infections, and to determine the dosing regimen of XC8, film-coated tablets, 10 mg for treatment of dry non-productive cough against acute respiratory infections.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signing and dating of the IPP informed consent form by the patient.
. Women and men between the ages of 18 and 65 years, inclusive, at the time of signing the informed consent form.
. Clinical diagnosis of acute respiratory viral infection of the upper respiratory tract (ICD-10 code J00-J06) or acute bronchitis (J20, J21 according to ICD-10).
. Onset of disease symptoms no more than 3 days prior to screening.
. Presence of a patient with a dry unproductive cough.
. Frequency of cough episodes ≥10 in the past 24 h before the screening visit and randomization.
. Cough frequency rated by the patient as 3-4 on the daytime cough section and 2-4 on the nighttime cough section of the Daytime and Nighttime Cough Scales.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coughing frequency
Timeframe: The estimate will include data from 24 hours to Day 1 and Day 5
. Trauma (including open wounds in the mouth and erosive-desquamous lesions of the oral mucosa) and/or oropharyngeal burns, scarlet fever, rubella, measles, mumps at the time of screening or within 3 months prior to screening.
. Acute obstructive laryngitis or suspected obstructive laryngitis.
. Presence of signs of laryngeal stenosis (stridor, shortness of breath).
. Exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (COPD).