Fluctuaties over de tijd van biomarkers bij patiënten met astma en gezonde controles; proof of concept voor het voorspellen van verlies van astma controle.
- Conditions
- The health condition studied will be asthma, the participants will be monitored during stable episodes and will subsequently undergo nasal inoculation with Rhinovirus for inducing loss of control/mild exacerbation.
- Registration Number
- NL-OMON23727
- Lead Sponsor
- Academic Medical Centre, Amsterdam
- Brief Summary
Muskulus M, Slats AM, Sterk PJ, Verduyn-Lunel S. Fluctuations and determinism of respiratory impedance in asthma and chronic obstructive pulmonary disease. J Appl Physiol (1985) 2010; 109:1582-91.<br><br> Frey U, Brodbeck T, Majumdar A, Taylor DR, Town GI, Silverman M, et al. Risk of severe asthma episodes predicted from fluctuation analysis of airway function. Nature 2005; 438:667-70.<br><br> Sinha A, Yadav AK, Chakraborty S, Kabra SK, Lodha R, Kumar M, et al. Exosome-enclosed microRNAs in exhaled breath hold potential for biomarker discovery in patients with pulmonary diseases. J Allergy Clin Immunol 2013; 132:219-22.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Asthma patients will be selected using the following inclusion criteria:
• Age 18-50 years
• History of episodic chest tightness and wheezing
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 Rhinovirus inoculation visit
• 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.
• Positive for any virus in nasal lavage at Rhinovirus inoculation day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method