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Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection | Clinical Trials | Clareo Health

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Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Assess Efficacy and Safety of HC8, Film-coated Tablets, 10 mg (Valenta Pharm, Russia) in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

NCT05269329•Valenta Pharm JSC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signing and dating of the IPP informed consent form by the patient.
•2. Women and men between the ages of 18 and 65 years, inclusive, at the time of signing the informed consent form.
•3. 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).
•4. Onset of disease symptoms no more than 3 days prior to screening.
•5. Presence of a patient with a dry unproductive cough.
•6. Frequency of cough episodes ≥10 in the past 24 h before the screening visit and randomization.
•7. 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.
•8. Patient rating of cough severity on the DRS ≥ 4 points.
•9. No indication for therapy due to BHSA infection at the time of study inclusion: negative rapid test for Group A β-haemolytic streptococcus.
•10. For women of preserved reproductive potential, a negative pregnancy test and agreement to use approved contraceptive methods for the duration of study participation, beginning at visit 0, and for 3 weeks after the end of the study; for men, agreement to use approved contraceptive methods throughout the study participation period and for 3 weeks after the end of the study.
+7 more criteria

Exclusion Criteria

•1. Known or suspected hypersensitivity to the active ingredient or any of the excipients of the study drug/placebo.
•2. Known or suspected hypersensitivity to acetylcysteine.
•3. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
•4. 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.
•5. Acute obstructive laryngitis or suspected obstructive laryngitis.
•6. Presence of signs of laryngeal stenosis (stridor, shortness of breath).
•7. Exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
•8. Bronchial asthma, including a history.
•9. History of tuberculosis.
•10. History of pulmonary emphysema.
+28 more criteria

Locations (9)

Ivanovo Kuvaev Clinical Hospital

Ivanovo, Russia

Kirov State Medical University

Kirov, Russia

Unimed-C Jsc

Moscow, Russia

Professors' Clinic LLC.

Perm, Russia

EosMED JSC

Saint Petersburg, Russia

Aurora MedFort LLC

Saint Petersburg, Russia

Private Healthcare Institution Clinical Hospital "RZD-Medicine" of St. Petersburg

Saint Petersburg, Russia

OrKli Hospital LLC.

Saint Petersburg, Russia

Medical Diagnostic Center LLC.

Yaroslavl, Russia

Key Dates

Start Date

April 26, 2021

Primary Completion Date

October 26, 2021

Completion Date

October 26, 2021

Last Updated

March 8, 2022

Enrollment

160

ACTUAL participants

Conditions

Common ColdAcute Respiratory InfectionInfluenza, Human

Interventions

XC8, film-coated tablets, 20 mg/day

DRUG

XC8, film-coated tablets, 40 mg/day

DRUG

XC8, film-coated tablets, 80 mg/day

DRUG

Placebo

DRUG

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

NCT07396428

Acute Respiratory InfectionInfluenza-like Illness

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RECRUITING

The Fever Clinic Acute Respiratory Cohort

NCT07278700

Acute Respiratory InfectionsFebrile Illnesses+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

Inclusion Criteria

Exclusion Criteria

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