A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.

NCT03415269 | Completed Phase 2

• 1 other identifier: IIT15419
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cough

Keywords

acute

Outcome Measures

Primary Outcomes (1)

• Cough reflex sensitivity

  To assess the effect of single dose of 20 mg ambroxol lozenge on cough reflex sensitivity (quatified by recording the concenteration of cough stimulant evoking 2 (C2) and 5 (C5 ) coughs) to four different types of challenge agents in acute cough associated with URTI.

  8 hours

Secondary Outcomes (3)

• Severity of cough Visual analogue scale (VAS)

  90 min post dose

• Urge to cough Visual analogue scale (VAS)

  90 min post dose

• Change in cough reflex sensitivity from during acute cough to post symptom recovery

  up tp 1 month

Study Arms (1)

20 mg ambroxol

EXPERIMENTAL

20 mg ambroxol lozenge delivered once on one day

Drug: Ambroxol Hydrochloride

Interventions

Ambroxol Hydrochloride DRUG

single lozenge of 20mg ambroxol

Also known as: Lysopain Ambr Mint™

20 mg ambroxol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use 2 forms of acceptable birth control from Screening through to the Follow Up Visit; or if a male, they and/or their partner of child-bearing potential agree to use 2 forms of acceptable birth control from Screening through the Follow Up Visit;
• Be able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.

You may not qualify if:

• History of asthma or other respiratory related disease
• 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
• 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
• History of a severe cutaneous adverse reaction to any treatment;
• Evidence of a possible bacterial infection i.e. sinus pain, purulent nasal discharge or pleuritic pain.
• Evidence of chest infection or pneumonia
• 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
• Demonstrate more than two coughs to inhalation of the normal saline solution during baseline challenge
• Current smoker or individuals who have given up smoking within the past 6 months or those with \>20 pack-year smoking history;
• Treatment with an ACE-inhibitor during the study or within 4 weeks prior to Screening
• History of opioid use within 1 week prior to baseline;
• Requiring concomitant therapy with prohibited medications
• History of known or suspected allergy or hypersensitivity reactions to ambroxol (e.g., asthma, urticaria or allergic type) or any of the non-medicinal ingredients contained in the study investigational product.
• Clinically significant abnormal electrocardiogram (ECG) at Screening;
• Personal or family history of congenital long QT syndrome or family history of sudden death;

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• Sanofi: collaborator

Study Sites (1)

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alyn H Morice

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: February 15, 2018
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: June 20, 2019

Record last verified: 2018-01

Locations

GB (1)