Patients with chronic cough MedDRA version: 16.1 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Levotuss Tosse 60 mg/ml gocce orali, soluzione
Product Name: Levotuss Tosse 60 mg/ml gocce orali, soluzione
Pharmaceutical Form: Oral drops, solution
CAS Number: 99291-25-5
Other descripti
Sponsors
Azienda Ospedaliero Universitaria Careggi, Firenze
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Normal subjects and/or outpatients of both sexes, aged between 20 and 70 years. 2. Patients with a clinical diagnosis of chronic cough, defined as a cough lasting for longer than 8 weeks who failed to present any significant improvement following treatment of the most commonly recognised causes of chronic cough. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Females of childbearing potential: pregnant or breast-feeding women, or lack of efficient contraception. 2. Clinically significant or unstable concurrent disease, such as: cardiovascular diseases (e.g. recent myocardial infarction, unstable coronary artery disease, heart failure NYHA class III-IV); significant pulmonary disease (e.g. tuberculosis, bronchiectasis, cystic fibrosis, lung cancer); cerebrovascular disease; significant hepatic and renal impairment; gastrointestinal disease (e.g. active peptic ulcer); recent surgical sutures; thoracic trauma or others. 3. Known or suspected hypersensitivity/intolerance to any of the study drugs. 4. Participation in another clinical study in the 60 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: .;Main Objective: To assess the actions of levodropropizine on respiratory centre output in normal subjects and in patients with chronic cough.;Secondary Objective: To compare the central action of levodropropizine with that of codeine, an effective, centrally acting anti-tussive agent with a recognised depressant activity on the respiratory neurones. ;Primary end point(s): Changes in inspiratory drive as assessed by comparing changes in the mean inspiratory flow, the pressure during airway occlusion, minute ventilation and inspiratory muscle activity during CO2 rebreathing challenges in control conditions and following administration of each study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in patient’s subjective perception of cough frequency and severity as assessed by means of standard scoring scales (Visual Analog Scale, VAS).;Timepoint(s) of evaluation of this end point: . | — |
Countries
Italy
Contacts
Public ContactDipartimento di Medicina Sperimenta
Azienda Ospedaliero Universitaria Careggi, Firenze
Outcome results
None listed