Detection of inhaled medication in exhaled breath condensate

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2017-003177-34-NL
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-06
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

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 <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.

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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
•Positive results for the HIV, HBV and HCV serology at screening.
•Excessive caffeine consumption, defined as > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified