Acute Respiratory InfectionPhase 3NCT06379542
Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections
A Phase 3 study testing XC8 in people with Acute Respiratory Infection, run by Valenta Pharm JSC at 6 sites in Russia.
Trial summary
The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Acute Respiratory Infection
- What is being tested?
- XC8
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 6 sitesRussia
- Study dates
- 4 Dec 2023to 31 Dec 2025
- Phase
- Phase 3
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient signing the Informed Consent Form and parent/adoptive parent signing the Parent/Adoptive Informed Consent Form.
- Male and female children between the ages of 6 and 17 years 10 months inclusive at the time of screening.
- Clinical diagnosis of acute respiratory viral upper respiratory tract infection (J00-J06 according to ICD-10) or acute bronchitis (J20, J21 according to ICD-10).
- Onset of disease symptoms no more than 3 days prior to screening.
- Presence of dry non-productive cough in the patient.
- Frequency of cough attacks ≥10 in the last 24 h before the screening visit and randomization.
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- Cough frequency rated by the patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) as 3-4 points on the "daytime cough" section and 2-4 points on the "nighttime cough" Daytime and nighttime cough scales.
- Patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) assessment of cough severity on the digital rating scale as ≥4 points.
- No indication for therapy due to BHSA infection at the time of inclusion in the study: negative rapid test for group A β-hemolytic streptococcus.
- For patients 14-17 years of age inclusive, consent to use reliable contraceptive methods throughout study participation and for 3 weeks after the end of the study.
- Reliable contraceptive methods are: sexual rest, condom use in combination with spermicide.
- Non-inclusion Criteria:
- Known or suspected hypersensitivity to the active substance or any of the excipients of the study drug/placebo.
- Known or suspected hypersensitivity to acetylcysteine.
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- Trauma (including open wounds in the oral cavity and erosive desquamous lesions of the oral mucosa) and/or burns of the oropharynx, scarlet fever, rubella, measles, epidemic mumps at the time of screening or within 3 months before screening.
- Acute obstructive laryngitis or suspected obstructive laryngitis.
- Presence of signs of laryngeal stenosis (stridor, dyspnea).
- Exacerbation of chronic bronchitis.
- Bronchial asthma, including history.
- Tuberculosis in the anamnesis.
- Emphysema of the lungs in the anamnesis.
- Acute or chronic pneumonia or suspected pneumonia.
- Condition after intubation.
- Gastroesophageal reflux being the primary cause of cough (in the opinion of the investigating physician).
- Allergic rhinitis being the primary cause of cough (in the opinion of the physician-researcher).
- Body temperature > 39.0 °C.
- Positive laboratory test result for SARS-CoV-2 antigen using an immunochromatographic assay at the time of screening1.
- Need for systemic antibiotic therapy and/or other drugs/procedures on the prohibited therapy/procedure list.
- Use of analgesics or antipyretics within 12 h prior to screening.
- Use of glucocorticosteroids, β-adrenoblockers, ACE inhibitors, theophylline preparations, expectorants, cough suppressants, anesthetics, anti-allergic drugs (leukotriene receptor antagonists, H1-histamine receptor blockers, sodium cromoglycate preparations), antiviral drugs, immunosuppressants, systemic antibacterial agents within 7 days before screening.
- A history of smoking.
- History of renal or hepatic impairment.
- History of oncologic diseases.
- Serious cardiovascular disease at the time of screening or within 12 months prior to screening, including: severe arrhythmias requiring treatment with antiarrhythmic drugs, unstable angina pectoris, heart and coronary artery surgery, stroke.
- Other severe, decompensated or unstable somatic diseases (any disease or condition that threatens the patient's life or worsens the patient's prognosis and makes it impossible for the patient to participate in the clinical trial).
- Unwillingness or inability of the patient/parent/adoptive parent to comply with the protocol procedures (in the opinion of the investigating physician).
- Pregnancy or breastfeeding period (for female patients).
- Alcoholism, drug dependence, substance abuse history and/or at the time of screening.
- A history of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric pathology.
- Participation in another clinical trial within 3 months prior to inclusion in the study.
- Other conditions that, in the opinion of the investigating physician, preclude the patient's inclusion in the study.
Who cannot join
- Identification of a confirmed case of COVID-19.
- Ineffectiveness of therapy - persistence or increase in cough attack frequency ≥1 by Visit 3 (Day 8-9) compared to Visit 1 (Day 1).
- Adverse events (AEs) requiring withdrawal of study drug/placebo.
- Occurrence of any disease or condition during the study that, in the opinion of the investigator, worsens the patient's prognosis and makes it impossible for the patient to continue participating in the clinical trial.
- Erroneous inclusion of a patient who does not meet the inclusion criteria and/or meets the criteria for non-inclusion.
- Taking any of the drugs of prohibited therapy, performing a prohibited procedure.
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- Need to prescribe a prohibited concomitant therapy/procedure.
- Pregnancy of the patient.
- Willingness of the patient and/or his/her parent/adoptive parent to terminate the patient's participation in the study.
- Lack of adequate cooperation of the patient and/or his/her parent/adoptive parent with the physician-researcher during the research process.
- Other protocol violations that in the opinion of the physician-researcher are significant.
- Other administrative reasons.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites, 6 recruiting
- Recruiting
City Pediatric Outpatient Clinic number 5
Perm, 614066
Olga Perminova, MD, PhD, +7 (912) 882 0549, perminova20062006@yandex.ru
- Recruiting
Professors' Clinic LLC.
Perm, 614070
Svetlana Teplykh, MD, PhD, +7 (919) 498 2931, profkliniki@mail.ru
- Recruiting
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44"
Saint Petersburg, 192071
Olga V Trusova, MD,PhD, +7 (812) 417-40-02, o-tru@mail.ru
- Recruiting
ArsVite North-West, LLC
Saint Petersburg, 194223
Svetlana G Lazareva, MD, +7-812-335-29-58, alexlaz58@rambler.ru
- Recruiting
PiterKlinika LLC
Saint Petersburg, 196158
Tatiana Pak, MD,PhD, +7 (981) 851 8150, pte@list.ru
- Recruiting
St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35"
Saint Petersburg, 196191
Tatiana I Antonova, MD, PhD, +7-812-246-46-45, antian@bk.ru
About this study
Official title: Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of XC8, Film-coated Tablets (Valenta Pharm JSC, Russia), in Children Aged 6-17 Years With Dry Non-productive Cough Against the Background of Acute Respiratory Viral Infection
The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo.
- Conditions
- Acute Respiratory Infection
- Being tested
- XC8, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC8Drug
40 mg/day or 80 mg/day for 7-14 days
PlaceboDrug
2 tablets/day for 7-14 days
| Study group | Role | What they receive |
|---|---|---|
| XC8, film-coated tablets, 20 mg, 40 mg | Experimental | 6-12 years old: 20 mg tablet, 2 per day for 7-14 days on top of standard therapy.
13-17 years old: 40 mg tablet, 2 per day for 7-14 days on top of standard therapy. Receives: Drug: XC8 |
| Placebo | Placebo comparator | 2 tablets per day for 7-14 days on top of standard therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1
Difference between the percentage of patients with ≥50% reduction in number of cough attacs by day 5 and by day 1
Measured: Assessment will include data collected within 24 hours before day 1 and day 5
Secondary outcomes (12)
Number of cough attacks by day 5, day 8, day 11 and day 15
Number of cough attacks registered by days 5, 8, 11, and 15
Measured: The estimate will include data collected within 24 hours before day 5, day 8, day 11 and day 15, respectively
Time (days) from visit 1 until clinical cough cure is achieved
Clinical cure of cough is defined as having ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the Daytime and Nighttime Cough Scale (a scale with scores from 0 to 5, where 0 is the absence of cough, and 5 is a severe cough that makes daytime activity impossible or a cough that makes it impossible to sleep) for at least 3 consecutive days.
Measured: The assessment will include the time from visit 1 to the first day of consecutive days on which ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the scales is recorded through the end of treatment (within timeframe from 7 to 14 days)
Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1
Score on the "daytime cough" and "nighttime cough" sections of the Daytime and Nighttime Cough Scale (a scale with scores from 0 to 5, where 0 is the absence of cough, and 5 is a severe cough that makes daytime activity impossible or a cough that makes it impossible to sleep)
Measured: The score for the "daytime cough" section will include data for days 4, 7, 10, and 14, respectively. The score for the "night cough" section will include data from the night prior to days 5, 8, 11, and 15, respectively.
Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1
Score assessed with digital rating scale (a scale from 0 to 10, where 0 is the absence of cough, and 10 is the most excruciating cough imaginable)
Measured: The score will include data 24 h before days 5, 8, 11 and 15, respectively
Percentage of patients needed acetylcysteine
Percentage of patients who were prescribed a preparation with acetylcysteine for transition of dry cough to wet cough
Measured: Day 1 - Day 21±2
Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14
Complete resolution of all symptoms is defined as achieving a score of 0 for each symptom on the Basic Symptom Rating Scale for acute respiratory infections (a 6-item inventory including Fatigue, Sore throat, Nasal congestion, Rhinorrhea, Myalgia, and Headache, assessed using a score from 0 to 3, where 0 is the absence of the symptom, and 3 is the most severe symptom severity)
Measured: Days 4, 7, 10, 14
Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5
Assessment of clinical effectiveness using Global Physician-Researcher Assessment of Therapy Effectiveness (a 5-point scale, where 1 is the absence of efficacy, and 5 is very high efficiency, meaning a complete cure of coughs)
Measured: Day 3-16
Number of adverse events (AEs)
Total number of AEs stratified by severity and frequency
Measured: Day 0 - Day 21±2
Adverse reactions
Frequency of adverse reactions
Measured: Day 0 - Day 21±2
Serious adverse events (SAEs)
Frequency of serious adverse events (SAEs) associated with study drug/placebo use
Measured: Day 0 - Day 21±2
Percentage of patients with AEs
Percentage of patients with at least one AE
Measured: Day 0 - Day 21±2
Percentage of patients who interrupted treatment
Percentage of patients who interrupted treatment due to AE
Measured: Day 0 - Day 21±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start4 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379542
- Sponsor's protocol ID
- XC8-03-05-2023
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of XC8, Film-coated Tablets (Valenta Pharm JSC, Russia), in Children Aged 6-17 Years With Dry Non-productive Cough Against the Background of Acute Respiratory Viral Infection
- ClinicalTrials.gov ID
- NCT06379542
- Acronym / sponsor ID
- XC8-03-05-2023
- Conditions
- Acute Respiratory Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Apr 2024 (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.
The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XC8, film-coated tablets, 20 mg, 40 mg | Experimental | Drug: XC86-12 years old: 20 mg tablet, 2 per day for 7-14 days on top of standard therapy. 13-17 years old: 40 mg tablet, 2 per day for 7-14 days on top of standard therapy. |
| Placebo | Placebo comparator | Drug: Placebo2 tablets per day for 7-14 days on top of standard therapy |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (42 listed)
- Patient signing the Informed Consent Form and parent/adoptive parent signing the Parent/Adoptive Informed Consent Form.
- Male and female children between the ages of 6 and 17 years 10 months inclusive at the time of screening.
- Clinical diagnosis of acute respiratory viral upper respiratory tract infection (J00-J06 according to ICD-10) or acute bronchitis (J20, J21 according to ICD-10).
- Onset of disease symptoms no more than 3 days prior to screening.
- Presence of dry non-productive cough in the patient.
Key exclusion criteria (12 listed)
- Identification of a confirmed case of COVID-19.
- Ineffectiveness of therapy - persistence or increase in cough attack frequency ≥1 by Visit 3 (Day 8-9) compared to Visit 1 (Day 1).
- Adverse events (AEs) requiring withdrawal of study drug/placebo.
- Occurrence of any disease or condition during the study that, in the opinion of the investigator, worsens the patient's prognosis and makes it impossible for the patient to continue participating in the clinical trial.
- Erroneous inclusion of a patient who does not meet the inclusion criteria and/or meets the criteria for non-inclusion.
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 |
|---|---|---|
| XC840 mg/day or 80 mg/day for 7-14 days | Drug | XC8, film-coated tablets, 20 mg, 40 mg |
| Placebo2 tablets/day for 7-14 days | Drug | Placebo |
Primary outcome
Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1
Time frame: Assessment will include data collected within 24 hours before day 1 and day 5
Difference between the percentage of patients with ≥50% reduction in number of cough attacs by day 5 and by day 1
12 secondary outcomes
Number of cough attacks by day 5, day 8, day 11 and day 15
Time frame: The estimate will include data collected within 24 hours before day 5, day 8, day 11 and day 15, respectively
Time (days) from visit 1 until clinical cough cure is achieved
Time frame: The assessment will include the time from visit 1 to the first day of consecutive days on which ≤ 1 score on the "daytime cough" and "nighttime cough" sections of the scales is recorded through the end of treatment (within timeframe from 7 to 14 days)
Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1
Time frame: The score for the "daytime cough" section will include data for days 4, 7, 10, and 14, respectively. The score for the "night cough" section will include data from the night prior to days 5, 8, 11, and 15, respectively.
Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1
Time frame: The score will include data 24 h before days 5, 8, 11 and 15, respectively
Percentage of patients needed acetylcysteine
Time frame: Day 1 - Day 21±2
Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14
Time frame: Days 4, 7, 10, 14
Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5
Time frame: Day 3-16
Number of adverse events (AEs)
Time frame: Day 0 - Day 21±2
Adverse reactions
Time frame: Day 0 - Day 21±2
Serious adverse events (SAEs)
Time frame: Day 0 - Day 21±2
Percentage of patients with AEs
Time frame: Day 0 - Day 21±2
Percentage of patients who interrupted treatment
Time frame: Day 0 - Day 21±2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- 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.
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44"
Saint Petersburg, Russia
6 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 XC8 in people with Acute Respiratory Infection, run by Valenta Pharm JSC at 6 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 42 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 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 6 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1 (time frame: Assessment will include data collected within 24 hours before day 1 and day 5). 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 23 Apr 2024.