Common ColdPhase 2NCT05269329
Efficacy and Safety of XC8, Film-coated Tablets, 10 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection
A Phase 2 study testing XC8, film-coated tablets, 20 mg/day, XC8, film-coated tablets, 40 mg/day and XC8, film-coated tablets, 80 mg/day in people with Common Cold and Acute Respiratory Infection, run by Valenta Pharm JSC at 9 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Cold, Acute Respiratory Infection, Influenza, Human
- What is being tested?
- XC8, film-coated tablets, 20 mg/day, XC8, film-coated tablets, 40 mg/day and XC8, film-coated tablets, 80 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 9 sitesRussia
- Study dates
- 26 Apr 2021to 26 Oct 2021
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
- No indication for therapy due to BHSA infection at the time of study inclusion: negative rapid test for Group A β-haemolytic streptococcus.
- 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.
Who cannot join
- Known or suspected hypersensitivity to the active ingredient 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 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).
Show all 46Show fewer
- Exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
- Bronchial asthma, including a history.
- History of tuberculosis.
- History of pulmonary emphysema.
- Acute or chronic pneumonia, or suspected pneumonia.
- Condition after intubation.
- Gastroesophageal reflux being the primary cause of cough (as judged by the investigating physician).
- Allergic rhinitis as primary cause of cough (according to study physician).
- Body temperature > 39.0 °C.
- Presence of at least one of the epidemic signs: return from a foreign trip 14 days prior to the onset of symptoms; presence of close contact in the past 14 days with a person under COVID-19 surveillance who has subsequently become ill; having close contact in the past 14 days with a person who has a laboratory-confirmed diagnosis of COVID-19; having occupational contacts with an individual with a suspected or confirmed case of COVID-19.
- Positive result of laboratory testing for SARS-CoV-2 RNA using nucleic acid amplification techniques or SARS-CoV-2 antigen using immunochromatographic analysis at the time of screening.
- The need for systemic antibiotic therapy and/or other drugs/procedures from the list of prohibited therapies/procedures.
- Use of analgesics or antipyretics within 12 hours prior to screening.
- Use of glucocorticosteroids, β-adrenoblockers, ACE inhibitors, theophylline drugs, expectorants, cough suppressants, anesthetics, anti-allergic drugs (leukotriene receptor antagonists, H1-histamine receptor blockers, sodium cromoglycate preparations), antiviral drugs, immunosuppressants, systemic antibacterial drugs for 7 days before screening.
- History of smoking more than 10 pack/years (pack-years: number of cigarettes smoked per day multiplied by the number of years of smoking divided by 20).
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels ≥ 2.5 × highest normal value, serum bilirubin levels ≥ 1.5 × highest normal value.
- Glomerular filtration rate (GFR) ≤ 60 ml/min.
- History of cancer of the respiratory system.
- History of other malignancies, except for patients who have not had the disease in the past 5 years, patients with fully cured basal cell carcinoma of the skin, or fully cured carcinoma in situ.
- Serious cardiovascular disease at the time of screening or within 12 months prior to screening, including: New York Heart Association Class III or IV chronic heart failure, severe arrhythmias requiring treatment with antiarrhythmic drugs, unstable angina pectoris, myocardial infarction, heart and coronary artery surgery, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure > 180 mm Hg Std. and diastolic blood pressure >110 mmHg, pulmonary embolism.
- Other severe, decompensated or unstable somatic diseases (any disease or condition that threatens the patient's life or worsens the patient's prognosis, or makes it impossible for the patient to participate in a clinical trial).
- Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the research physician).
- Pregnancy or breastfeeding (for women).
- 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 inclusion of the patient in the study.
- Withdrawal Criteria:
- Identification of a probable or confirmed case of COVID-19
- Ineffectiveness of therapy - persistence or increased frequency of cough attacks ≥ 1 by visit 3 (day 8-9) compared to visit 1 (day 1).
- AEs requiring withdrawal of study drug/placebo.
- The occurrence of any disease or condition during the study that, in the opinion of the study physician, worsens the patient's prognosis and also 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 inclusion criteria.
- Taking any of the drugs of prohibited therapy, performing a prohibited procedure.
- The necessity of prescribing prohibited concomitant therapy/procedures.
- Pregnancy of the patient.
- Patient's desire to stop participating in the study.
- Lack of adequate cooperation of the patient with the doctor-researcher during the study.
- Other protocol violations that are significant in the opinion of the physician-researcher.
- Other administrative reasons.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
Ivanovo Kuvaev Clinical Hospital
Ivanovo, 153025
Kirov State Medical University
Kirov, 610027
Unimed-C Jsc
Moscow, 119571
Professors' Clinic LLC.
Perm, 614070
EosMED JSC
Saint Petersburg, 194000
Aurora MedFort LLC
Saint Petersburg, 194156
Private Healthcare Institution Clinical Hospital "RZD-Medicine" of St. Petersburg
Saint Petersburg, 195271
OrKli Hospital LLC.
Saint Petersburg, 199178
Medical Diagnostic Center LLC.
Yaroslavl, 150000
About this study
Official title: 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
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.
- Conditions
- Common Cold, Acute Respiratory Infection, Influenza, Human
- Being tested
- XC8, film-coated tablets, 20 mg/day, XC8, film-coated tablets, 40 mg/day, XC8, film-coated tablets, 80 mg/day, Placebo
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC8, film-coated tablets, 20 mg/dayDrug
20 mg/day (1 tablet twice a day)
XC8, film-coated tablets, 40 mg/dayDrug
40 mg/day (2 tablets twice a day)
XC8, film-coated tablets, 80 mg/dayDrug
80 mg/day (4 tablets twice a day)
PlaceboDrug
1, 2, or 4 tablets twice a day
| Study group | Role | What they receive |
|---|---|---|
| XC8, film-coated tablets, 20 mg/day | Experimental | Not described Receives: Drug: XC8, film-coated tablets, 20 mg/day |
| XC8, film-coated tablets, 40 mg/day | Experimental | Not described Receives: Drug: XC8, film-coated tablets, 40 mg/day |
| XC8, film-coated tablets, 80 mg/day | Experimental | Not described Receives: Drug: XC8, film-coated tablets, 80 mg/day |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coughing frequency
Change in coughing frequency by ≥ -50% by day 5 relative to visit 1
Measured: The estimate will include data from 24 hours to Day 1 and Day 5
Secondary outcomes (32)
Frequency of cough episodes
Frequency of cough episodes by 5, 8, 11, and 15 days after visit 1
Measured: The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively.
Time to clinical cough cure
Time (days) from visit 1 to achievement of clinical cough cure. Clinical cough cure is defined as having ≤ 1 score on the Daytime Cough and Nighttime Cough Scales for at least 3 consecutive days.
Measured: From Day 1 (visit 1) to the first day of consecutive days on which ≤ 1 point on the Daytime Cough and Nighttime Cough Scales sections of the Daytime and Nighttime Cough Scales is recorded, assessed up to Day 16 (visit 5).
Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections
Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections by days 5, 8, 11, and 15 after visit 1.
Measured: The daytime cough section score will include data for days 4, 7, 10, and 14, respectively. The nighttime cough section score will include data for the night preceding days 5, 8, 11, and 15, respectively.
Change (score) in cough severity
Change (score) in cough severity according to the digital rating scale (DRS) by days 5, 8, 11, and 15 compared to visit 1.
Measured: The score will include data 24 h before days 5, 8, 11, and 15, respectively.
Time (days) from visit 1 to a reduction in cough severity
Time (days) from visit 1 to a reduction in cough severity by DRS of ≥2 points.
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Percentage of patients prescribed acetylcysteine
Percentage of patients who were prescribed acetylcysteine for the conversion of dry to wet cough.
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Time (days) from visit 1 to administration of acetylcysteine
Estimated only in patients who were prescribed acetylcysteine.
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Proportion of patients dropped out of the study due to prescription of systemic antibiotic therapy.
Proportion of patients dropped out of the study due to prescription of systemic antibiotic therapy due to the development of complications of the disease
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Time (days) from visit 1 to achieving ≤ 1 score on the daytime cough
Time (days) from visit 1 to achieving ≤ 1 score on the daytime cough section Scales of daytime and nighttime cough.
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Change (score) in daytime cough
Change (score) in daytime cough section Daytime and nighttime cough scales (from 0 - no cough episodes to 5 - severe cough, which makes normal activity impossible) by days 4, 7, 10, and 14 compared to visit 1.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with a score ≤ 1 on the daytime cough
Proportion of patients with a score ≤ 1 on the daytime cough section Daytime and nighttime cough scales by days 4, 7, 10, and 14 after visit 1.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Percentage of patients with ≥1 point decrease in daytime cough
Percentage of patients with ≥1 point decrease in daytime cough section Daytime and nighttime cough scales by 4, 7, 10, and 14 days post-visit 1.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with ≥ 2 points reduction in daytime cough
Proportion of patients with ≥ 2 points reduction in "daytime cough" Scales of daytime and nighttime cough by 4, 7, 10, and 14 days after visit 1.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Time (days) from visit 1 to reaching ≤ 1 score on the nighttime cough
Time (days) from visit 1 to reaching ≤ 1 score on the nighttime cough section Scales for daytime and nighttime cough.
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Change (score) in the nighttime cough
Change (score) in the nighttime cough section Day and night cough scales (from 0 - no cough episodes to 5 - cough that prevents a subject from falling asleep) by days 5, 8, 11, and 15 compared to visit 1.
Measured: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Proportion of patients with a score ≤ 1 on nighttime cough
Proportion of patients with a score ≤ 1 on nighttime cough Scales of day and night cough by days 5, 8, 11, and 15 after visit 1.
Measured: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Percentage of patients with ≥1 point decrease in nighttime cough
Percentage of patients with ≥1 point decrease in nighttime cough section Scales of day and night cough by 5, 8, 11, and 15 days after visit 1.
Measured: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Percentage of patients with a reduction of ≥ 2 points in the nighttime cough
Percentage of patients with a reduction of ≥ 2 points in the nighttime cough section Day and night cough scales by days 5, 8, 11, and 15 after visit 1.
Measured: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Change in the number of episodes of nocturnal awakening due to cough
Change in the number of episodes of nocturnal awakening due to cough by days 5, 8, 11, and 15 compared to visit 1.
Measured: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Time (days) to attain ≤ 1 score for each symptom
Time (days) to attain ≤ 1 score for each symptom on the Acute Respiratory Infection Major Symptom Rating Scale
Measured: From Day 1 (visit 1) up to Day 16 (visit 5).
Proportion of patients with attainment of ≤ 1 point on each symptom
Proportion of patients with attainment of ≤ 1 point on each symptom on the Acute Respiratory Infection Major Symptom Rating Scale by days 4, 7, 10, and 14
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Percentage of patients with a decrease of ≥1 score on each symptom
Percentage of patients with a decrease of ≥1 score on each symptom on the Acute Respiratory Infection Major Symptom Rating Scale by days 4, 7, 10, and 14
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Change in each symptom score
Change in each symptom score on the Acute Respiratory Infection Major Symptom Rating Scale by days 4, 7, 10, and 14 compared to visit 1.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with body temperature ≤ 37.0 °C
Proportion of patients with body temperature ≤ 37.0 °C by Visits 2-5. Patients who had a body temperature ≤ 37.0°C at Visit 1 will not be included in the analysis for that symptom.
Measured: From Day 3-4 (visit 2) up to Day 16 (visit 5).
Percentage of patients with complete resolution of all symptoms
Percentage of patients with complete resolution of all acute respiratory infection symptoms by days 4, 7, 10, and 14.
Measured: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with "very high" and "high" efficacy
Proportion of patients with "very high" and "high" efficacy at visits 2, 3, 4, and 5 by physician's assessment.
Measured: From Day 3-4 (visit 2) up to Day 16 (visit 5).
Proportion of patients with each category of Global Assessment scale
Proportion of patients with each category of Global Assessment by the physician at visits 2, 3, 4, and 5.
Measured: From Day 3-4 (visit 2) up to Day 16 (visit 5).
Safety - Adverse Events (AEs)
Total number of AEs stratified by severity and frequency
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Adverse Reactions
Frequency of Adverse Reactions
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Serious adverse events (SAEs)
Frequency of SAEs associated with the use of the study drug/placebo
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients with at least one AE
Percentage of patients with at least one AE
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients who interrupted the treatment due to AE
Percentage of patients who interrupted the treatment due to the occurrence of AE
Measured: From visit 0 up to Day 20 +/- 2 (visit 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start26 Apr 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269329
- Sponsor's protocol ID
- XC8-02-01-2020
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05269329
- Acronym / sponsor ID
- XC8-02-01-2020
- Conditions
- Common Cold, Acute Respiratory Infection, Influenza, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 8 Mar 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XC8, film-coated tablets, 20 mg/day | Experimental | Drug: XC8, film-coated tablets, 20 mg/day |
| XC8, film-coated tablets, 40 mg/day | Experimental | Drug: XC8, film-coated tablets, 40 mg/day |
| XC8, film-coated tablets, 80 mg/day | Experimental | Drug: XC8, film-coated tablets, 80 mg/day |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (46 listed)
- Known or suspected hypersensitivity to the active ingredient 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 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.
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 |
|---|---|---|
| XC8, film-coated tablets, 20 mg/day20 mg/day (1 tablet twice a day) | Drug | XC8, film-coated tablets, 20 mg/day |
| XC8, film-coated tablets, 40 mg/day40 mg/day (2 tablets twice a day) | Drug | XC8, film-coated tablets, 40 mg/day |
| XC8, film-coated tablets, 80 mg/day80 mg/day (4 tablets twice a day) | Drug | XC8, film-coated tablets, 80 mg/day |
| Placebo1, 2, or 4 tablets twice a day | Drug | Placebo |
Primary outcome
Coughing frequency
Time frame: The estimate will include data from 24 hours to Day 1 and Day 5
Change in coughing frequency by ≥ -50% by day 5 relative to visit 1
32 secondary outcomes
Frequency of cough episodes
Time frame: The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively.
Time to clinical cough cure
Time frame: From Day 1 (visit 1) to the first day of consecutive days on which ≤ 1 point on the Daytime Cough and Nighttime Cough Scales sections of the Daytime and Nighttime Cough Scales is recorded, assessed up to Day 16 (visit 5).
Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections
Time frame: The daytime cough section score will include data for days 4, 7, 10, and 14, respectively. The nighttime cough section score will include data for the night preceding days 5, 8, 11, and 15, respectively.
Change (score) in cough severity
Time frame: The score will include data 24 h before days 5, 8, 11, and 15, respectively.
Time (days) from visit 1 to a reduction in cough severity
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Percentage of patients prescribed acetylcysteine
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Time (days) from visit 1 to administration of acetylcysteine
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Proportion of patients dropped out of the study due to prescription of systemic antibiotic therapy.
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Time (days) from visit 1 to achieving ≤ 1 score on the daytime cough
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Change (score) in daytime cough
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with a score ≤ 1 on the daytime cough
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Percentage of patients with ≥1 point decrease in daytime cough
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with ≥ 2 points reduction in daytime cough
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Time (days) from visit 1 to reaching ≤ 1 score on the nighttime cough
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Change (score) in the nighttime cough
Time frame: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Proportion of patients with a score ≤ 1 on nighttime cough
Time frame: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Percentage of patients with ≥1 point decrease in nighttime cough
Time frame: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Percentage of patients with a reduction of ≥ 2 points in the nighttime cough
Time frame: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Change in the number of episodes of nocturnal awakening due to cough
Time frame: Assessment will include data for the night before days 5, 8, 11, and 15, respectively.
Time (days) to attain ≤ 1 score for each symptom
Time frame: From Day 1 (visit 1) up to Day 16 (visit 5).
Proportion of patients with attainment of ≤ 1 point on each symptom
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Percentage of patients with a decrease of ≥1 score on each symptom
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Change in each symptom score
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with body temperature ≤ 37.0 °C
Time frame: From Day 3-4 (visit 2) up to Day 16 (visit 5).
Percentage of patients with complete resolution of all symptoms
Time frame: Assessment will include data for days 4, 7, 10, and 14, respectively.
Proportion of patients with "very high" and "high" efficacy
Time frame: From Day 3-4 (visit 2) up to Day 16 (visit 5).
Proportion of patients with each category of Global Assessment scale
Time frame: From Day 3-4 (visit 2) up to Day 16 (visit 5).
Safety - Adverse Events (AEs)
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Adverse Reactions
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Serious adverse events (SAEs)
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients with at least one AE
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Safety - Percentage of patients who interrupted the treatment due to AE
Time frame: From visit 0 up to Day 20 +/- 2 (visit 6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XC8, film-coated tablets, 20 mg/day, XC8, film-coated tablets, 40 mg/day and XC8, film-coated tablets, 80 mg/day in people with Common Cold and Acute Respiratory Infection, run by Valenta Pharm JSC at 9 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 10 inclusion and 46 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coughing frequency (time frame: The estimate will include data from 24 hours to 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 8 Mar 2022.