NL-OMON46822
Completed
Not Applicable
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 - Detection of medication concentrations in exhaled breath condensate
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General inclusion criteria for all study subjects
- •\- Healthy male subjects, 18 to 65 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 35 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 \* 2\-agonists on an \*as needed\* basis only.
- •\- Clinically stable asthma, i.e. stable use of an \*as needed\* short\-acting \*2 agonist
- •\- Post\-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.
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) \< 60 ml/min.
Outcomes
Primary Outcomes
Not specified
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