Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough

Kholood Altassan7 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Cough

Interventions

oral spray of MgCl2DEVICE

Magnesium Salt Oral Spray Device

SalineDEVICE

oral saline aerosol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

King Saud University Hospital

Riyadh, Saudi Arabia