Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough … (NCT05273619) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection
Russia250 participantsStarted 2022-05-23
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 infection.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
✓. Patient rating of cough severity on the DRS ≥ 4 points.
Exclusion criteria
✕. Known or suspected hypersensitivity to the active ingredient or any of the excipients of the study drug/placebo.
✕. Known or suspected hypersensitivity to acetylcysteine.
✕. 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.
What they're measuring
1
Coughing frequency
Timeframe: The estimate will include data from 24 hours to Day 1 and Day 5