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Table 2 Study procedures

From: Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial

 

Genotype screening visit 0a

Enrollment visit 1b

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7/end-of-trial

Monthly phone calls

Follow-up/end-of-trial phone call

Early end of study visit

Month

  

4

8

12

16

20

24

 

EOT + 6 wks

 

Targeted Day

 

1

120

240

360

480

600

720

   

Visit Window (days)

 

− 28 to 1c

 ± 7

 ± 7

 ± 7

 ± 7

 ± 7

 ± 7

 ± 4

 ± 4

 

Informed consent

X

Xd

         

Demographics

X

Xd

         

Medical history

 

X

         

Eligibility Review

X

X

         

Randomization

 

X

         

Complete Physical exam

 

X

         

Brief Physical exame

  

X

X

X

X

X

X

  

X

Vital signs

 

X

X

X

X

X

X

X

  

X

Study Site Spirometryf

 

X

X

X

X

X

X

X

  

X

Home spirometry tutorial and spirometer provided

 

Xg

         

DLCOf

 

X

X

X

X

X

X

X

  

X

QOL questionnairesh

 

X

  

X

  

X

  

X

COVID-19 Questionnaire

 

X

X

X

X

X

X

X

  

X

Home Spirometry Surveyi

   

X

 

X

 

Xj

  

Xj

Complete blood count (CBC)

 

X

     

X

  

X

Chemistries and liver function tests

 

X

X

X

X

X

X

X

  

X

Pregnancy Testk

 

X

 

X

 

X

 

X

  

X

Blood for genotype

Xl

          

Biomarkers and gene expression (plasma, serum, RNA, cells, buccal, fecal)

 

X

X

X

X

X

X

X

  

X

Hospitalization Assessment

  

X

X

X

X

X

X

X

X

X

AE review and evaluation

 

X

X

X

X

X

X

X

X

Xm

X

Conmed review

 

X

X

X

X

X

X

X

X

X

X

Administer study drug

 

X

X

X

X

X

X

    

Distribute Drug Diary

 

X

X

X

X

X

X

    

Collect and Review Drug Diary

  

X

X

X

X

X

X

  

X

Study drug accountability

  

X

X

X

X

X

X

  

X

  1. EOT End of treatment
  2. Genotype Screen Participants: Participants recruited for the study without a prior confirmed TT TOLLIP genotype
  3. Genotype Confirmed Participants: Participants that have a confirmed TT TOLLIP genotype prior to recruitment for PRECISIONS, through participation in the Pulmonary Fibrosis Foundation Registry and Biorepository or other Biorepository. Genotype has been confirmed by the Clinical Coordinating Center (CCC) and communicated to the site prior to the site contacting the participant
  4. aVisit 0 (Genotype Screening Visit) will be performed for genotype screen participants only. Visit 1 may be performed only after the site reviews the genotype results to confirm eligibility. Genotype results are expected to be available to report to sites within 14 days
  5. bAll assessments at Visit 1 must be performed before administration of the study drug
  6. cVisit 1 procedures may be completed over a 4 week time period. If a participant is found ineligible at Visit 1, but later meets criteria, they may return to the study site to complete any outstanding Visit 1 procedures within 4 weeks. If a participant does not complete all Visit 1 procedures or does not meet the eligibility criteria within 4 weeks of Visit 1, they must be scheduled for a re-screen visit. Please refer to Sect. 8.1.1 for further information
  7. dInformed consent and Demographics do not have to be repeated at Visit 1 if they were completed at Visit 0 (Genotype Screening Visit)
  8. eA brief physical exam will be conducted at visits 2 through 7. Brief physical exams will include assessment of general appearance, respiratory, cardiovascular, dermatologic, and abdominal system
  9. fPFTs for routine clinical care done within 28 days of Visit 1 at the study site’s PFT lab may be used for baseline, only if the participant has been clinically stable over that time period. If the participant has not been stable, PFTs should be done prior to randomization in order to assess eligibility criteria
  10. gParticipants will be provided with a home spirometer and training. Participants will perform home spirometry during Visit 1. This procedure should not be performed if the participant opted out of home spirometry in the informed consent
  11. hLeicester cough questionnaire, EuroQOL EQ-5D, UCSD-Shortness of Breath Questionnaire, K-BILD, SGRQ, R-Scale-PF
  12. iHome Spirometry Survey will only be given to participants who opted in to home spirometry
  13. jThe Home Spirometry Exit Survey should be give at Visit 7/Early End of Study Visit
  14. kPregnancy urine dipstick testing will be done for women of childbearing potential only
  15. lGenotype screen participants will have their blood drawn for genotype testing at Visit 0, only after signing the PRECISIONS study consent. Genotype results are expected to be available to report to sites within 14 days
  16. mStudy staff will record all new reportable events with start dates occurring any time after informed consent is obtained until Visit 7 (for non-serious AEs) or 30 days (for SAEs) after the last study visit, End of Treatment Visit (EOT) or Visit 7
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BMC Pulmonary Medicine

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