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

NCT07003347 | Completed

• 1 other identifier: SC-RCC- KSU001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24 hour cough frequency

  From Baseline to Day 56

Secondary Outcomes (6)

• 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)

  From Baseline to Day 56

• Patient Global Impression of Change (PGIC, 7-point scale)

  From Baseline to Day 56

• Change in pulmonary lung function test (FEV1 and FVC)

  From Baseline to Day 56

• Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ)

  From Baseline to Day 56

Other Outcomes (4)

• 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.

  From Baseline to Day 56

Study Arms (2)

oral spray of MgCl2

EXPERIMENTAL

Device: oral spray of MgCl2

Placebo

PLACEBO COMPARATOR

Device: Saline

Interventions

oral spray of MgCl2 DEVICE

Magnesium Salt Oral Spray Device

oral spray of MgCl2

Saline DEVICE

oral saline aerosol

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kholood Altassan: lead

Study Sites (1)

King Saud University Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor at Department of Family and Community Medicine

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 4, 2025
• Study Start: December 19, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)