Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Ventolin® Solution for Intravenous Infusion 5mg in 5ml (1mg/ml)
Product Name: Ventolin® Solution for Intravenous Infusion 5mg in 5ml (1mg/ml).
Pharmaceutical Form: Solution for infusion
IN
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: General inclusion criteria for all study subjects • Healthy male subjects, 18 to 45 years of age, inclusive. • Non-smokers or ex-smokers (stopped for at least 6 months before screening, and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General exclusion criteria for all study subjects • Known hypersensitivity to any excipients of the drug formulations; history of anaphylaxis or severe allergy for food or medication. • Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year. • History or clinical evidence of any disease and/or existence of a surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug. • Clinically relevant history or evidence of cardiovascular disease (including angina pectoris and arrhythmias), hypertension, hyperthyroidism, renal disease, diabetes mellitus or glucose intolerance. • Clinically relevant history of chronic or malignant diseases (except for basal cell carcinoma or squamous cell carcinoma of the skin). • Clinically significant findings on physical examination. • Clinically relevant abnormalities in 12-lead ECG. • Any clinically significant abnormalities in blood (chemistry, hematology) or urine results. • Renal clearance (MDRD formula) 8 cups/per day at screening – unable to discontinue caffeine consumption for at least 8 hours before and during the testing. • History or clinical evidence of alcoholism within the 3-year period prior to screening (i.e. regular use of more than 21 units of alcohol/week). • Positive results for urine drug and cotinine at screening. • Recent respiratory tract infections (in 3 weeks before screening). • Clinically meaningful blood loss (including blood donation), or a transfusion of any blood product within 12 week before screening. Specific exclusion criteria for healthy volunteers • A (family) history of hearing problems, clinical significant tinnitus or vestibular problems. • History of hypersensitivity for sulphite or aminoglycosides. • Clinically relevant pulmonary abnormalities. Specific exclusion criteria for asthmatic subjects • Clinically significant findings on physical examination other than allergy and mild to moderate persistent asthma. • Controller therapy with anti-IgE (omalizumab) in the 6 months before screening. • Systemic, inhaled or intranasal medication use of the following: corticosteroids in 4 weeks before screening (8 weeks for systemic use), leukotriene receptor antagonists (LTRA), cromones, theophyllines, long actin beta agonists (LABA) in the 2 weeks before screening. • Desensitization therapy in the past. • Severe exacerbation requiring hospital evaluation and/or admission in the past 2 years. • Clinically relevant pulmonary comorbidity, other than asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: • To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin. • To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and salbutamol concentrations can be better described by concentrations in the EBC compared to plasma. ;Secondary Objective: Secondary objectives: • To determine intra- and inter-subject variability of salbutamol and tobramycin concentrations in EBC after i.v. and inhaled administration. • To determine the relationship between salbutamol and tobramycin concentrations in the EBC and plasma after i.v. and inhaled administration. • Compare plasma/lung ratios between healthy volunteers and mild-moderate asthmatics with regard to the area under the curve (0-7h). ;Primary end point(s): Pharmacokinetic endpoints After study drug administration, PK in blood and EBC will be assessed by taking multiple paired blood and EBC samples at pre-specified time points. Pharmacodynamic endpoints Pulmonary function tests (Spirometry) will be performed only in asthma patients. Tolerability / safety endpoints Serious adverse events ((S)AEs) will be collected throughout the study. ;Timepoint(s) of evaluation of this end point: Healty volunteers: study day 1, 2, 3 and 4 Asthma patients: study day 1 and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N.A.;Timepoint(s) of evaluation of this end point: N.A. | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Centre for Human Drug Research
Outcome results
None listed