A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough. (NCT03415269) | Clinical Trial Compass
CompletedPhase 2
A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.
United Kingdom14 participantsStarted 2018-02-15
Plain-language summary
To assess the effect of a single doses of 20 mg ambroxol hydrochloride on cough reflex sensitivity to citric acid, capsaicin, adenosine triphosphate (ATP) and distilled water in patients with acute cough related to upper respiratory tract infection
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Be informed of the nature of the study and have provided written informed voluntary consent;
✓. Be able to speak, read, and understand English;
✓. Be males or females, of any race, between 18 and 80 years of age, inclusive;
✓. Subject has an acute cough and other symptoms consistent with a common cold or an acute upper respiratory tract infection (URTI) diagnosis deemed by the investigator based on findings from medical history review, full physical examination and vital signs;
✓. The onset of symptoms must be within 72 h of study enrolment;
✓. Have a Cough Severity VAS ≥ 40 mm at Screening;
✓. Be in good general health (other than URTI) with no clinically relevant abnormalities based on the medical history, physical examination, and 12 lead electrocardiogram;
✓. Cough at least twice to all cough challenge Agents - citric acid, capsaicin, ATP and distilled water cough challenges at baseline.
Exclusion criteria
✕1. History of asthma or other respiratory related disease
✕2. Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (e.g., seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator
✕3. Clinical features of a complication of the common cold during the physical examination at screening (e.g., otitis media, sinusitis, or pneumonia) with or without the need for systemic antibiotics
What they're measuring
1
Cough reflex sensitivity
Timeframe: 8 hours
Trial details
NCT IDNCT03415269
SponsorHull University Teaching Hospitals NHS Trust
✕4. History of a severe cutaneous adverse reaction to any treatment;
✕5. Evidence of a possible bacterial infection i.e. sinus pain, purulent nasal discharge or pleuritic pain.
✕6. Evidence of chest infection or pneumonia
✕7. Fever greater than 39ºC (102ºF oral temperature) at the time of screening if, in the judgment of the investigator, the individual is too ill to participate in the study or the fever is due to reasons other than URTI
✕8. Demonstrate more than two coughs to inhalation of the normal saline solution during baseline challenge