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Run-In Period
Wash Out Period
Treatment Period
Patient Taking fluticasone
No steroids or LABA
Patient Taking Randomization Drug
If Exacerbation or Infection
If Exacerbation or Infection
If Exacerbation or Infection
Discontinue Study Treatment
Blood drawn if possible during
Exacerbation/Infection
Blood drawn if possible during
Exacerbation/Infection
Exacerbation
Treatment
Exacerbation
Treatment
Continue with regular medications
for 2 weeks post-treatment of
exacerbation or infection
Continue with regular medications for
2 weeks post-treatment of
exacerbation or infection
Blood drawn if possible during
Exacerbation/Infection
Exacerbation
Treatment
Continue with regular medications
for 2 weeks post-treatment of
exacerbation or infection
Return to week 1(visit)
Return to week 1(visit
Return to Week 7
Restart Run-In Phase
Restart Run-In Phase
Restart Treatment Phase
Exacerbation/Infection Flow Sheet
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