acute cough assouciated with URTI MedDRA version: 20.0 Level: LLT Classification code 10066522 Term: Acute cough System Organ Class: 100000004855
Conditions
Interventions
Trade Name: lysopaine
Product Name: lysopaine
Product Code: NA
Pharmaceutical Form: Lozenge
INN or Proposed INN: ambroxol hydrochloride
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Be informed of the nature of the study and have provided written informed voluntary consent; 2 Be able to speak, read, and understand English; 3 Be males or females, of any race, between 18 and 80 years of age, inclusive; 4 Subject has an acute cough and other symptoms consistent with a common cold /acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator or qualified designee based on findings from medical history review, full physical examination and vital signs; 5 The onset of symptoms must be within 72 h of study enrolment; 6 Have a Cough Severity VAS = 40 mm at Screening; 7 Be in good general health (other than URTI) with no clinically relevant abnormalities based on the medical history, physical examination, and 12 lead electrocardiogram; 8 Cough at least twice to all cough challenge Agents-citric acid, Capsaicin, ATP and distilled water cough challenges at baseline. 9 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 the Follow Up Visit; or if a male, they and/or their partner of child-bearing potential agree to use 1 form of acceptable birth control from Screening through the Follow Up Visit; 10 Be able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 11 History of asthma or other respiratory related disease 12 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 13 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 systematic antibiotics 14 Evidence of a possible bacterial infection i.e. sinus pain, purulent nasal discharge or pleuritic pain. 15 Evidence of chest infection or pneumonia 16 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 17 Demonstrate more than two coughs to inhalation of the normal saline solution during baseline challenge 18 Current smoker or individuals who have given up smoking within the past 6 months or those with >20 pack-year smoking history; 19 Treatment with an ACE-inhibitor during the study or within 4 weeks prior to Screening 20 History of opioid use within 1 week prior to baseline; 21 Requiring concomitant therapy with prohibited medications (see Section 7.5) 22 History of known or suspected allergy or hypersensitivity reactions to ambroxol (e.g., asthma, urticaria or allergic type any of the non-medicinal ingredients contained in study investigational products. 23 Clinically significant abnormal electrocardiogram (ECG) at Screening; 24 Personal or family history of congenital long QT syndrome or family history of sudden death; 25 Pregnant or breastfeeding; 26 Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion; 27 Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine the effect of single dose of 20 mg ambroxol lozenge on cough severity VAS and urge-to-cough VAS in subjects with acute cough associated with URTI • To evaluate changes in cough reflex sensitivity during acute cough associated with URTI in relation to the healthy (post-recovery) state. • To assess the safety and tolerability of ambroxol ; Timepoint(s) of evaluation of this end point: Vas- at baseline, 30 min and 90 min post dose and between baseline and follow-up (approx 4 weeks). Cough refelx-baseline and followup (approx 4 weeks) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the effect of a single dose of 20 mg ambroxol lozenge on cough reflex sensitivity in patients with acute cough. Cough sensitivity will be measured using an artificially induced cough model, stimulating cough with four different types of challenge agents (citric acid,capsaicin,ATP and distilled water).; Secondary Objective: •To determine the effect of single dose of 20 mg ambroxol lozenge on cough severity VAS and urge-to-cough VAS in subjects with acute cough associated with URTI •To evaluate changes in cough reflex sensitivity during acute cough associated with URTI in relation to the healthy (post-recovery) state. •To assess the safety and tolerability of ambroxol ;Primary end point(s): •To assess the effect of single dose of 20 mg ambroxol lozenge on cough reflex sensitivity to four different types of challenge agents in acute cough associated with URTI.;Timepoint(s) of evaluation of this end point: 30 mibn and 90 min post dose | — |
Countries
United Kingdom
Contacts
Public ContactCaroline Wright
University of Hull
Outcome results
None listed