A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough

Официальное название

A Randomized, Double-Blind, Placebo Controlled, Parallel-Arm Pilot Evaluation - to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough

Обзор

This is a randomized placebo-controlled, parallel-arm study to determine the safety and efficacy of SC0032 in participants with RCC

Подробное описание

There are three parts to this study and an optional fourth part:

1. an optional Usability Sub-Study, 2. Part 1: Two Week Treatment (Run-In) Period, 3. Part 2:Three Week Treatment (Parallel Arm) Period and 4. Part 3: Four Week No Treatment (Follow-Up) Period, Participants completing the three primary parts of the study will attend four study visits. Participation in the optional Usability sub-study does not require any additional visits, see Figure 1. Trial Schema. Participants who do not meet criteria for Part 2, the Parallel Arm Period, at the end of Part 1, the Run-In period, will only be required to attend two study visits and will not receive an active treatment. Participants who discontinue the study prior to completion will be asked to complete an Early Termination Visit.

Вмешательства

• Комбинированный продукт SC0032
  Magnesium Chloride
• Устройство Placebo
  Sodium Chloride

Первичные конечные точки

• Difference in mean % change from baseline in 24-hour cough frequency using the mean of Days -8 to -2 for last 7 days of baseline vs the mean of Days 13-19 last 7 days of the treatment period, using the HYFE continuous cough monitor). [Срок оценки: Day -8 to Day 19.]

Вторичные конечные точки (12)

• Time to onset of response based on median time (in days) from start of treatment to first day when mean treatment effect ≥30%, based on cumulative daily averages using the HYFE continuous cough monitor) from Day 1 to Day 20. [Срок оценки: From Day 1 to Day 20]
• Determine duration of response (≥30% reduction relative to baseline) from baseline (mean of Days -8 to -2) vs the Follow up period (mean of Days 22-28, 29-35, 36-42 and 43-49). [Срок оценки: Day -8 to Day 49]
• Change in number of cough bouts per 24-hour period, defined using inter-cough gap thresholds of 2.0s, from Day -14 to -2 and Day 1 to Day 21. [Срок оценки: From Day -14 to Day 21]
• Change in Leicester Cough questionnaire (LCQ) score on Day 0 vs Day 21. A 19-item, patient-completed health-related quality of life (HRQoL) for chronic cough. Each item is rated on a 7-point Likert scale (1-7), with higher score indicates better QoL. [Срок оценки: Day 0 to Day 21]
• Change in Cough Severity Visual Analogue Scale (CS-VAS) score (0-100mm line anchored with "no cough" at 0 mm and "worst cough imaginable" at 100 mm) from Day 0 and Day 21. [Срок оценки: Day 0 to Day 21]
• Change in Patient Global Impression of Severity 5-point score (PGI-S) score from Day 0 and Day 21. Response options typically range from "None" to "Severe", with higher scores indicating greater symptom severity. [Срок оценки: Day 0 to Day 21]
• Change in categorical Patient Global Impression of Change (PGI-C) score from Day 0 and Day 21 analyzed as the proportion of participants achieving improvement on the 7-point scale. Response options range from "Very much improved" to "Very much worse." [Срок оценки: Day 0 to Day 21]
• Change in Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ) score from Day 0 and Day 21. A 14-item tool measuring subjective laryngeal sensory symptoms. Items are rated on a 7-point Likert scale, with lower scores indicating greater severity. [Срок оценки: Day 0 to Day 21]
• Change in mean daily cough from Day -8 to -2 vs Day 13-19 in Daily Cough Numeric Rating Scale (CS-NRS), an 11-point PRO rating severity of their cough over the past 24 hours. The scale ranges from 0 ("no cough") to 10 ("worst possible cough"). [Срок оценки: Day -8 to Day 19]
• Report incidence of treatment-emergent adverse events (TEAEs). [Срок оценки: Day -14 to Day 49]
• Report the severity of TEAEs. [Срок оценки: Day -14 to Day 49]
• Change from in FEV₁ and FVC from Day -14 to Day 49 by treatment group. [Срок оценки: Day -14 to Day 49]

Критерии участия

Критерии включения

• Males and females between 18 and 80 years.
• Capable of giving signed informed consent.
• Diagnosed with RCC (including unexplained chronic cough) for at least 6 months.
• At least 8 coughs per hour, 24-hour cough frequency during the 14-day Run-In Period.
• Score ≥ 40 mm on cough severity VAS at Screening.
• Normal FEV1/FVC ratio of greater than 70% at Screening
• A negative test for COVID-19.
• Women of child-bearing potential and men must agree to use a highly effective contraception method during the study and for at least 14 days after the last dose.
• Willing to carry study-related equipment as required for the study (e.g. cough monitor, phone).

Критерии исключения

• Current smoker/vaper (all forms of smoking and inhaled substances, including cannabis/tobacco smoke and nicotine vapours) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history.
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis, uncontrolled asthma or other serious pulmonary disease.
• Respiratory tract infection within 4 weeks before screening.
• History of malignancy in the last 5 years, unless it is a non-serious skin cancer.
• History of moderate or severe alcohol or drug use disorder within the last 3 years.
• Opioid use with in the 7 days prior to screening.
• History of a positive serologic test for hepatitis B virus surface antigen, or hepatitis C virus.
• Previous participation in a clinical trial in the last 30 days or 6-half half-lives of test drug activity.
• Current participation in or completion of speech language therapy intervention therapy for chronic cough within 8 weeks prior to screening.
• Use of Prohibited medications within 4 weeks prior to screening and at any time during the study: anti-tussive therapy, systemic corticosteroids, ACE inhibitors, opioids.
• Gabapentin and pregabalin are prohibited unless they are being administered for treatment of a condition other than RCC and have been on a stable dose of that medication for at least 6 weeks prior to screening and plan to remain on that dose for the duration of the study.
• Tricyclic antidepressants are prohibited unless they are being administered for treatment of a condition other than RCC and have been on a stable dose of that medication for at least 12 weeks prior to screening and plan to remain on that dose for the duration of the study.
• Beta blockers are prohibited unless they are on a stable dose for at least 6 weeks prior to screening.
• Use of dietary supplements containing magnesium for the duration of the study.
• History of myocardial infarction or other cardiac disorders as follows:

• History of any of the following within 6 months prior to screening, myocardial infarction, stroke or transient ischemic attack, coronary revascularization (PCI or CABG), or heart failure.
• History of clinically significant arrhythmias, poorly controlled hypertension.
• Any condition that, in the opinion of the investigator, places the participant at high risk for an acute cardiovascular event including but not limited to: angina symptomatic peripheral arterial disease, severe valvular heart disease, planned cardiovascular intervention or surgery during the study period, baseline QTc interval >450 ms (men) or >470 ms (women), or any clinically significant ECG abnormality as determined by the Investigator.
• History of any clinically significant or psychiatric condition that, in the eyes of the Investigator or designee, would not be suitable for this study. Or if, in the eyes of the Investigator or designee may prove non-compliant to study procedures.
• Spouses or other family members with a chronic cough in the household.
• Living and working in an excessively loud workplace (e.g. building site).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 3 центра

• The Wellcome Trust-Wolfson Northern Ireland Clinical Research Facility U Floor, Belfast Ci — Belfast
• Kings College Hospital — London
• Royal Brompton Hospital — London

Идентификаторы

NCT: NCT07690059 · SC-RCC-UK002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗