Dates galore
What is the LABA/LAMA washout period?
2 weeks
How many participants are needed for the entire study?
60
Who determines eligibility?
The PI
What is the latest protocol and amendment?
V2.1
When is the interim analysis data pull?
July 28th
When should all spirometry reports be uploaded to TechEd?
Within 24 hrs
Which PI and site enrolled the first participant?
Dr. Fogarty and the team at Spartenburg
Is BMI automatically calculated in the EDC?
Yes after height and weight are entered into EDC
How often should BioQCs be submitted to Tech Ed?
Monthly
How long does the subject need to be on a medium-dose ICS before screening?
At least 6 weeks
Who should be contacted whenever there is a challenge with the study device, Empatica or Koneksa Platform?
The Help Desk
Can participants travel internationally while on the study?
Yes, but the Help desk must be contacted with specific country information and will assist with planning with the device
How often should syringe linearity be submitted to TechEd?
Biweekly
What percentage of screening tests does the participant need to pass the screening?
The participant needs to complete 75% of the screening testing completed
Who is doing the mobile spirometer overreading?
ArtiQ
What is kh008@techedconsultants.com?
The portal for all spirometry, BioQCs, syringe linearity and calibration reports