Refractory Chronic Cough and Unexplained Chronic Cough study: SC0032
Official title A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
ClinicalTrials.gov ID: NCT07690059
What this study is testing
What is SC0032?
an investigational combination product being studied for refractory chronic cough and unexplained chronic cough
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new mouth spray helps with coughs. It also checks if the spray is safe to use.
- Who it's for
- You may be able to join if you are an adult with a long-lasting cough.
- What's involved
- You would use a small spray in your mouth. You might get the real spray or a pretend one with no medicine.
- Time commitment
- The study lasts for a set time with visits to check on your health.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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.
You likely can't join if
- Current smoker/vaper (all forms of smoking and inhaled substances, including cannabis/tobacco smoke and nicotine vapours) or individuals who have...
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis, uncontrolled asthma or other serious...
- 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.
See the full eligibility criteria
- 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).
- 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...
- 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...
- 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...
- 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 any of the following within 6 months prior to screening, myocardial infarction, stroke or transient ischemic attack, coronary revascularization (PCI or CABG), or heart failure.
- History of clinically significant arrhythmias, poorly controlled hypertension.
- Any condition that, in the opinion of the investigator, places the participant at high risk for an acute cardiovascular event including but not limited to: angina symptomatic peripheral arterial disease, severe valvular...
- History of any clinically significant or psychiatric condition that, in the eyes of the Investigator or designee, would not be suitable for this study.
- Spouses or other family members with a chronic cough in the household.
- Living and working in an excessively loud workplace (e.g. building site).
The study team makes the final eligibility decision.
Where it is enrolling
- Belfast, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Belfast, United Kingdom; London, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.