Chronic CoughREACHNCT07003347
Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough
A study testing oral spray of MgCl2 and Saline in people with Chronic Cough, run by Kholood Altassan at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Cough
- What is being tested?
- oral spray of MgCl2 and Saline
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 19 Dec 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- oral spray of MgCl2, Saline
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral spray of MgCl2Device
Magnesium Salt Oral Spray Device
SalineDevice
oral saline aerosol
| Study group | Role | What they receive |
|---|---|---|
| oral spray of MgCl2 | Experimental | Not described Receives: Device: oral spray of MgCl2 |
| Placebo | Placebo comparator | Not described Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24 hour cough frequency
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to Day 56
Change in pulmonary lung function test (FEV1 and FVC)
Measured: From Baseline to Day 56
Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ)
Score range from 14 to 98. Lower score indicate greater severity.
Measured: 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)
Measured: 14 Days of Dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start19 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kholood Altassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kholood Altassan, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003347
- Sponsor's protocol ID
- SC-RCC- KSU001
- Acronym
- REACH
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07003347
- Acronym / sponsor ID
- REACH / SC-RCC- KSU001
- Conditions
- Chronic Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Kholood AltassanUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral spray of MgCl2 | Experimental | Device: oral spray of MgCl2 |
| Placebo | Placebo comparator | Device: Saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral spray of MgCl2Magnesium Salt Oral Spray Device | Device | oral spray of MgCl2 |
| Salineoral saline aerosol | Device | Placebo |
Primary outcome
Change from baseline in 24 hour cough frequency
Time frame: From Baseline to Day 56
6 secondary outcomes
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
Change in cough severity using a visual analogue scale (100 mm visual scale)
Time frame: From Baseline to Day 56
Patient Global Impression of Change (PGIC, 7-point scale)
Time frame: From Baseline to Day 56
Change in pulmonary lung function test (FEV1 and FVC)
Time frame: From Baseline to Day 56
Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ)
Time frame: 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)
Time frame: 14 Days of Dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral spray of MgCl2 and Saline in people with Chronic Cough, run by Kholood Altassan at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24 hour cough frequency (time frame: From Baseline to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.