Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection

NCT05273619 | Completed Phase 3

• 1 other identifier: XC8-03-03-2021
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Common Cold; Acute Respiratory Infection; Influenza, Human

Outcome Measures

Primary Outcomes (1)

• Coughing frequency

  Reduced coughing frequency by ≥50% by day 5 relative to visit 1

  The estimate will include data from 24 hours to Day 1 and Day 5

Secondary Outcomes (13)

• Frequency of cough episodes

  The assessment will include data for 24 h before days 5, 8, 11, and 15, respectively.

• Time to clinical cough cure

  The assessment will include the time from 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.

• Proportion of patients with ≤ 1 score on the daytime cough and nighttime cough Scales sections

  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

  The score will include data 24 h before days 5, 8, 11, and 15, respectively.

• Percentage of patients prescribed acetylcysteine

  From Day 1 (visit 1) up to Day 16 (visit 5)

Study Arms (2)

XC8, film-coated tablets, 10 mg

EXPERIMENTAL

Drug: XC8, film-coated tablets, 10 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XC8, film-coated tablets, 10 mg DRUG

80 mg/day: 4 tablets (40 mg) twice a day

XC8, film-coated tablets, 10 mg

Placebo DRUG

4 tablets twice a day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (6)

Ivanovo Kuvaev Clinical Hospital

Ivanovo, 153025, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation

Kirov, 610027, Russia

Location

Unimed-C Jsc

Moscow, 119571, Russia

Location

EosMED JSC

Saint Petersburg, 194000, Russia

Location

OrKli Hospital LLC.

Saint Petersburg, 199178, Russia

Location

Uromed LLC

Smolensk, 214031, Russia

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 10, 2022
• Study Start: May 23, 2022
• Primary Completion: July 13, 2022
• Study Completion: July 29, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

RU (6)