Chronic Cough
Conditions
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.
Interventions
DEVICEoral spray of MgCl2
Magnesium Salt Oral Spray Device
DEVICESaline
oral saline aerosol
Sponsors
Kholood Altassan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 24 hour cough frequency | From Baseline to Day 56 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From Baseline to Day 56 | — |
| Change in cough severity using a visual analogue scale (100 mm visual scale) | From Baseline to Day 56 | 100 mm is the worst outcome, 0 is the best outcome. |
| Patient Global Impression of Change (PGIC, 7-point scale) | 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. |
| Change in pulmonary lung function test (FEV1 and FVC) | From Baseline to Day 56 | — |
| Newcastle Laryngeal Hypersensitivity Questionnaire (LHQ) | From Baseline to Day 56 | Score range from 14 to 98. Lower score indicate greater severity. |
| 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) | 14 Days of Dosing | — |
Countries
Saudi Arabia
Outcome results
None listed