Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough (REACH)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Device: oral spray of MgCl2; Device: Saline

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Saud University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Device: Saline; oral saline aerosol
Experimental: oral spray of MgCl2	Device: oral spray of MgCl2; Magnesium Salt Oral Spray Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 24 hour cough frequency	From Baseline to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		From Baseline to Day 56
Change in cough severity using a visual analogue scale (100 mm visual scale)	100 mm is the worst outcome, 0 is the best outcome.	From Baseline to Day 56
Patient Global Impression of Change (PGIC, 7-point scale)	Maximum score is 7 and 1 is the minimum score. Higher scores indicate improvement, lower score indicate worsening in condition.	From Baseline to Day 56
Change in pulmonary lung function test (FEV1 and FVC)		From Baseline to Day 56
Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ)	Score range from 14 to 98. Lower score indicate greater severity.	From Baseline to Day 56
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)		14 Days of Dosing

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exhaled breath condensate (EBC) pH (using an EBC monitor) relative to baseline and placebo over 14 days		14 Days of Dosing
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.		From Baseline to Day 56
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.	100 mm is the worst outcome and 0 mm is the best outcome.	From Baseline to Day 56
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.		From Baseline to Day 56

Collaborators and Investigators

• Sponsor: Kholood Altassan

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 25, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough
• Other Study ID Numbers: SC-RCC- KSU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No