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Clinical Trials/NL-OMON23727
NL-OMON23727
Recruiting
Not Applicable

Temporal fluctuations of biomarkers in patients with asthma and controls: Proof of concept for predicting loss of control - BIOFLUC

Academic Medical Centre, Amsterdam0 sites24 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
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.
Sponsor
Academic Medical Centre, Amsterdam
Enrollment
24
Status
Recruiting
Last Updated
last year

Overview

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.

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.

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Academic Medical Centre, Amsterdam

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

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 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

Outcomes

Primary Outcomes

Not specified

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