Microglia Activation in Asthma — MAIA  

Asthma Clinical Trial

Official title: Microglia Activation in Asthma

Status Recruiting

Clinical Trial Summary

The primary purpose of this study is to provide preliminary data to determine if an acute increase in airway inflammation, provoked by an inhaled allergen challenge, is associated with an increase in microglial activation and may inform whether individuals with asthma, in the long-term, are at increased risk for neurodegeneration, cognitive decline, and forms of dementia. Though in the long-term airway inflammation may be associated with neurodegenerative processes, these changes reflect the accumulation over a lifetime of allergen exposures and disease-related changes. This relationship between peripheral inflammation and microglial activation is analogous to the impact of sleep loss. No single night of poor sleep will lead to long-term change in brain structure, function, or cognitive function, but the accumulation of frequent and repeated sleep loss over a lifetime has been shown to have a major impact. These data will be used for a larger scale study to determine if asthma is a risk factor for neurodegeneration, and will inform brain health issues in asthma more broadly.

Clinical Trial Description

First schedule version:

Screening Visit 0: Consent/Eligibility, Pregnancy Test, Vital Signs, Medical History, Concomitant Meds, Allergy Skin Test, Spirometry, Physical Exam, Blood Draw, MRI Simulation, Fraction of exhaled nitric oxide (FeNO)

Screening Visit 0a: Pregnancy Test, Vital Signs, Adverse Events, Concomitant Meds, Spirometry, WLAC, Fraction of exhaled nitric oxide (FeNO)

Visit 1: Pregnancy Test, Vital Signs, Adverse Events, Concomitant Meds, Spirometry, Blood Draw, Sputum Induction, Fraction of exhaled nitric oxide (FeNO), Cognitive Tests, PET/MRI Scan, Questionnaires

Visit 2: Vital Signs, Adverse Events, Concomitant Meds, Spirometry, Physical Exam, WLAC, Blood Draw, Fraction of exhaled nitric oxide (FeNO)

Visit 3: Pregnancy Test, Vital Signs, Adverse Events, Concomitant Meds, Spirometry, Blood Draw, Sputum Induction, Fraction of exhaled nitric oxide (FeNO), Cognitive Tests, PET/MRI Scan, Questionnaires

Visit 4: Adverse Events, Spirometry, Fraction of exhaled nitric oxide (FeNO)

Second schedule version:

Screening Visit 0: Consent/Eligibility, Pregnancy Test, Vital Signs, Medical History, Concomitant Meds, Allergy Skin Test, Spirometry, Physical Exam, Blood Draw, MRI Simulation

Screening Visit 0a: Pregnancy Test, Vital Signs, Adverse Events, Concomitant Meds, Spirometry, WLAC

Visit 1: Pregnancy Test, Vital Signs, Adverse Events, Concomitant Meds, Spirometry, Blood Draw, Sputum Induction, Fraction of exhaled nitric oxide (FeNO), Cognitive Tests, PET/MRI Scan, Questionnaires

Visit 2: Vital Signs, Adverse Events, Concomitant Meds, Spirometry, Physical Exam, WLAC, Blood Draw, Fraction of exhaled nitric oxide (FeNO), Cognitive Tests, PET/MRI Scan, Questionnaires

Visit 3: Vital Signs, Adverse Events, Concomitant Meds, Spirometry, Blood Draw, Sputum Induction, Fraction of exhaled nitric oxide (FeNO)

Visit 4: Adverse Events, Spirometry, Fraction of exhaled nitric oxide (FeNO) ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT04307667
• Study type: Observational
• Source: University of Wisconsin, Madison
• Contact: Jane Sachs
• Phone: 6088902980
• Email: jfsachs@wisc.edu
• Status: Recruiting
• Start date: December 17, 2019
• Completion date: December 1, 2028