NL-OMON44025
Completed
Not Applicable
Temporal fluctuations of biomarkers in patients with asthma and controls: Proof of concept for predicting loss of control. - BIOFLUC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Asthma patients will be selected using the following inclusion criteria:
- •Age 18\-50 years
- •History of episodic chest tightness and wheezing
- •Intermittent or mild to moderate persistent asthma according to the criteria by the Global
- •Initiative for Asthma (Global Initiative of Asthma. www.ginasthma.org)
- •Non\-smoking or stopped smoking more than 12 months ago and 5 pack years or less
- •Clinically stable, no exacerbations within last six weeks prior to study
- •Steroid\-naïve or those participants who are currently not on corticosteroids and have not taken any corticosteroids by any dosing\-routes within 6 weeks prior to the study or only using on\-demand reliever therapy
- •Baseline pre\-bronchodilator FEV1 \>\= 70% of predicted
- •Airway hyperresponsiveness, indicated by a positive methacholine bromide (MeBr) challenge test with PC20\<\= 9\.8 mg/ml
Exclusion Criteria
- •Potential subjects who meet any of the following criteria will be excluded from participation in the study:
- •Women who are pregnant, lactating or have a positive urine pregnancy test at baseline visit
- •Participation in any clinical investigational drug treatment protocol within the preceding 5 half\-lives of the drug (or 12 weeks if the half life is unknown) before the screening visit
- •Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient;Furthermore the following additional exclusion criteria will be used in part 2 of the study:
- •RV16 titre \> 1:8 in serum, measured at screening (visit 1\) and also at visit 24
- •History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light\-headedness
- •History of an asthma exacerbation within the last 6 weeks prior to the study
- •Has had any acute illness, including a common cold, within 4 weeks prior to visit 1
- •Close contact with young children or with any immunosuppressed patients
- •Has donated blood or has had a blood loss of more than 450 mL within 60 days prior to screening visit 1 or plans to donate blood during the study.
Outcomes
Primary Outcomes
Not specified
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