A clinical study to assess the feasibility of measuring inhaled medication concentrations in exhaled breath condensate obtained from healthy volunteers and asthma patients and to assess the relationship with clinical endpoints

Centre for Human Drug Research0 sites24 target enrollmentDecember 6, 2017

Overview

No summary available.

Registry

who.int

Start Date

December 6, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•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 \<10 pack\-years).
•Body mass index (BMI) between 18 and 30 kg/m2\.
•Able to participate and willing to give written informed consent and to comply with the study restrictions.
•Specific inclusion criteria for asthmatic subjects
•History of mild to moderate persistent asthma, first diagnosed at least 6 months prior to the screening visit and currently controlled by ß2\-agonists on an as needed” basis only.
•Clinically stable asthma, i.e. stable use of an as needed” short\-acting ß2\-agonist.
•Pre\-bronchodilator FEV1 \= 70% of predicted.
•Demonstrate an increase in FEV1 of \= 12 % and 200 mL within 30 minutes after administration of 400 microgram inhaled salbutamol at screening.

•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) \< 60 ml/min.