A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough

NCT07690059 | Not Yet Recruiting Phase 2

• 1 other identifier: SC-RCC-UK002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized placebo-controlled, parallel-arm study to determine the safety and efficacy of SC0032 in participants with RCC

Conditions

Refractory Chronic Cough and Unexplained Chronic Cough

Keywords

RCC; UCC; Refractory Chronic Cough; Unexplained Chronic Cough; SC0032

Outcome Measures

Primary Outcomes (1)

• Difference in mean % change from baseline in 24-hour cough frequency using the mean of Days -8 to -2 for last 7 days of baseline vs the mean of Days 13-19 last 7 days of the treatment period, using the HYFE continuous cough monitor).

  Linear mixed model with log-transformed daily cough frequency as response variable, fixed effect for treatment, and random effects for participants; fitted model yields point estimate and 95% CI estimate of placebo-adjusted treatment effect

  Day -8 to Day 19.

Secondary Outcomes (19)

• Time to onset of response based on median time (in days) from start of treatment to first day when mean treatment effect ≥30%, based on cumulative daily averages using the HYFE continuous cough monitor) from Day 1 to Day 20.

  From Day 1 to Day 20

• Determine duration of response (≥30% reduction relative to baseline) from baseline (mean of Days -8 to -2) vs the Follow up period (mean of Days 22-28, 29-35, 36-42 and 43-49).

  Day -8 to Day 49

• Change in number of cough bouts per 24-hour period, defined using inter-cough gap thresholds of 2.0s, from Day -14 to -2 and Day 1 to Day 21.

  From Day -14 to Day 21

• Change in Leicester Cough questionnaire (LCQ) score on Day 0 vs Day 21. A 19-item, patient-completed health-related quality of life (HRQoL) for chronic cough. Each item is rated on a 7-point Likert scale (1-7), with higher score indicates better QoL.

  Day 0 to Day 21

• Change in Cough Severity Visual Analogue Scale (CS-VAS) score (0-100mm line anchored with "no cough" at 0 mm and "worst cough imaginable" at 100 mm) from Day 0 and Day 21.

  Day 0 to Day 21

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sodium Chloride

Device: Placebo

SC0032

EXPERIMENTAL

Magnesium Chloride

Combination Product: SC0032

Interventions

SC0032 COMBINATION_PRODUCT

Magnesium Chloride

SC0032

Placebo DEVICE

Sodium Chloride

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 and 80 years.
• Capable of giving signed informed consent.
• Diagnosed with RCC (including unexplained chronic cough) for at least 6 months.
• At least 8 coughs per hour, 24-hour cough frequency during the 14-day Run-In Period.
• Score ≥ 40 mm on cough severity VAS at Screening.
• Normal FEV1/FVC ratio of greater than 70% at Screening
• A negative test for COVID-19.
• Women of child-bearing potential and men must agree to use a highly effective contraception method during the study and for at least 14 days after the last dose.
• Willing to carry study-related equipment as required for the study (e.g. cough monitor, phone).

You may not qualify if:

• Current smoker/vaper (all forms of smoking and inhaled substances, including cannabis/tobacco smoke and nicotine vapours) 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, uncontrolled asthma or other serious pulmonary disease.
• Respiratory tract infection within 4 weeks before screening.
• History of malignancy in the last 5 years, unless it is a non-serious skin cancer.
• History of moderate or severe alcohol or drug use disorder within the last 3 years.
• Opioid use with in the 7 days prior to screening.
• History of a positive serologic test for hepatitis B virus surface antigen, or hepatitis C virus.
• Previous participation in a clinical trial in the last 30 days or 6-half half-lives of test drug activity.
• Current participation in or completion of speech language therapy intervention therapy for chronic cough within 8 weeks prior to screening.
• Use of Prohibited medications within 4 weeks prior to screening and at any time during the study: anti-tussive therapy, systemic corticosteroids, ACE inhibitors, opioids.
• Gabapentin and pregabalin are prohibited unless they are being administered for treatment of a condition other than RCC and have been on a stable dose of that medication for at least 6 weeks prior to screening and plan to remain on that dose for the duration of the study.
• Tricyclic antidepressants are prohibited unless they are being administered for treatment of a condition other than RCC and have been on a stable dose of that medication for at least 12 weeks prior to screening and plan to remain on that dose for the duration of the study.
• Beta blockers are prohibited unless they are on a stable dose for at least 6 weeks prior to screening.
• Use of dietary supplements containing magnesium for the duration of the study.
• History of myocardial infarction or other cardiac disorders as follows:

Sponsors & Collaborators

• Sensory Cloud, Inc.: lead

Study Sites (3)

The Wellcome Trust-Wolfson Northern Ireland Clinical Research Facility U Floor, Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

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: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Combination product SC0032 versus placebo.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: July 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

GB (3)