Clinical trial NCT07003347: Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough
Official title: A Randomized, Double-Blind, Placebo Controlled Cross- Over Study to Investigate the Efficacy and Safety of SC0023, a Magnesium Salt Oral Spray Device, in Adults With Refractory or Unexplained Chronic Cough
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Cough
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo controlled cross-over study to investigate the efficacy and safety of SC0023 (an oral spray of magnesium based alkaline hypertonic divalent salt) in adults with refractory or unexplained chronic cough over 14 days.

Approximately 20 participants being enrolled and randomized into the study.


Eligibility criteria: Inclusion Criteria:

* Males and females between 18-80 years
* Capable of giving signed informed consent
* Diagnosed with RCC (including unexplained chronic cough) for at least 6 months and at least 4 coughs per hour on average during awake hours at Screening.
* Score ≥ 40 mm on cough severity VAS at screening.
* Normal FEV/FVC
* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose.

Exclusion Criteria:

* Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) 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 or uncontrolled asthma.
* Respiratory tract infection within 4 weeks before screening.
* History of malignancy in the last 5 years.
* History of alcohol or drug abuse within the last 3 years.
* Opioid use in last 7 days of screening.
* History of a positive serologic test for, hepatitis B virus surface antigen, or hepatitis C virus.
* Previous participation in clinical trial in last 30 days or 6-half lives of test drug activity.
* Use of prohibited medications anti-tussive therapy, gabapentin, pregabalin, baclofen, tricyclics, systemic corticosteroids, ACE inhibitors, beta blockers.
* Use of dietary supplements containing magnesium for the duration of the study.
* History of myocardial infarction or other cardiac disorders.
* 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 noncompliant to study procedures.
* Spouses or other family members with a chronic cough in household or
* Living and working in an excessively loud workplace (e.g. building site)

Primary outcomes:
measure: Change from baseline in 24 hour cough frequency
timeFrame: From Baseline to Day 56
Secondary outcomes:
measure: Percentage of participants with a reduction from baseline in the 24-hour cough frequency by ≥ 30%, 50% and 70% compared with placebo. Assessed using HYFE digital cough monitor.
timeFrame: From Baseline to Day 56
measure: Change in cough severity using a visual analogue scale (100 mm visual scale)
timeFrame: From Baseline to Day 56
measure: Patient Global Impression of Change (PGIC, 7-point scale)
timeFrame: From Baseline to Day 56
measure: Change in pulmonary lung function test (FEV1 and FVC)
timeFrame: From Baseline to Day 56
measure: Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ)
timeFrame: From Baseline to Day 56
measure: Safety and Tolerability over 14 days of dosing: a. Incidence (% of subjects) of treatment-emergent adverse events (TEAEs) b. Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)
timeFrame: 14 Days of Dosing
Other outcomes:
measure: Change in exhaled breath condensate (EBC) pH (using an EBC monitor) relative to baseline and placebo over 14 days
timeFrame: 14 Days of Dosing
measure: This study will characterize cough counts over the duration of the study and explore the effect of air quality (where adopted) on cough count and the impact of SC0023 on this parameters.
timeFrame: From Baseline to Day 56
measure: This study will characterize cough counts over the duration of the study and explore the effect of air quality (where adopted) on visual analogue scale (100 mm visual scale) and the impact of SC0023 on this parameters.
timeFrame: From Baseline to Day 56
measure: This study will characterize cough counts over the duration of the study and explore the effect of air quality (where adopted) on lung function and the impact of SC0023 on this parameters.
timeFrame: From Baseline to Day 56
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University Hospital
Study officials:
References: