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Completed

NCT Number: NCT07003347

Study to Investigate the Efficacy and Safety of SC0023, 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University Hospital

Riyadh, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

oral spray of MgCl2

Device

Magnesium Salt Oral Spray Device

Saline

Device

oral saline aerosol

Primary outcomes

  1. Change from baseline in 24 hour cough frequency

    Time frame: From Baseline to Day 56

Secondary outcomes

  1. 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.

    Time frame: From Baseline to Day 56

  2. Change in cough severity using a visual analogue scale (100 mm visual scale)

    Time frame: From Baseline to Day 56

    100 mm is the worst outcome, 0 is the best outcome.

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

    Time frame: From Baseline to Day 56

    Maximum score is 7 and 1 is the minimum score. Higher scores indicate improvement, lower score indicate worsening in condition.

  4. Change in pulmonary lung function test (FEV1 and FVC)

    Time frame: From Baseline to Day 56

  5. Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ)

    Time frame: From Baseline to Day 56

    Score range from 14 to 98. Lower score indicate greater severity.

  6. 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)

    Time frame: 14 Days of Dosing

Other outcomes

  1. Change in exhaled breath condensate (EBC) pH (using an EBC monitor) relative to baseline and placebo over 14 days

    Time frame: 14 Days of Dosing

  2. 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.

    Time frame: From Baseline to Day 56

  3. 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.

    Time frame: From Baseline to Day 56

    100 mm is the worst outcome and 0 mm is the best outcome.

  4. 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.

    Time frame: From Baseline to Day 56

Sponsors and collaborators

Lead sponsor

Kholood Altassan

Other

Registry information

Official study 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

Acronym: REACH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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