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

NCT ID: NCT07003347

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oral spray of MgCl2

Group Type: EXPERIMENTAL

oral spray of MgCl2

Intervention Type: DEVICE

Magnesium Salt Oral Spray Device

Placebo

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

oral saline aerosol

Interventions

oral spray of MgCl2

Magnesium Salt Oral Spray Device

Intervention Type: DEVICE

Saline

oral saline aerosol

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kholood Altassan

OTHER

Sponsor Role: lead

Responsible Party

Kholood Altassan

Assistant Professor at Department of Family and Community Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

King Saud University Hospital

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Kholood Altassan

Role: CONTACT

akholood@ksu.edu.sa

+966539703589

Bashyer Alotaibi

Role: CONTACT

+966552455066

Facility Contacts

Kholood Altassan

Role: primary

akholood@ksu.edu.sa

+966539703589

Other Identifiers

SC-RCC- KSU001

Identifier Type: -

Identifier Source: org_study_id