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Table 2 Study visits and participant timeline

From: Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations

 

Enrolment

Week 0

Week 4

Week 8

Week 12

Week 16

Week 20

Week 24

Week 28

Week 32

Week 36

Week 40

Week 44

Week 48

Follow-up

Written informed consent

X

              

Demography

X

X

             

Eligibility verification

X

X

             

Allocation

 

X

             

Complete physical exam

X

              

Vital signs including Sp02

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Height

X

              

Weight

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Urine pregnancy test1

X

              

Pulmonary function test or spirometry

X

Xa

X

 

X

  

X

  

X

  

X

 

Target physical exam

  

X

 

X

  

X

  

X

  

X

 

Immunoglobulin profiles and other hematological and biochemical tests2

X

 

Xb

 

Xb

  

Xb

  

Xb

  

Xb

 

CT chest, chest X-ray, sinus X-ray3

X

X

             

ECG, nasopharyngeal swab, sputum culture4

X

X

             

Medical history

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Adverse event assessment

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Concomitant medications

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Infusion of Ig or normal saline

 

X

X

X

X

X

X

X

X

X

X

X

X

X

 

EQ-5D-5L questionnaire

 

X

X

 

X

  

X

  

X

  

X

 

SGRQ questionnaire5

 

X

X

 

X

  

X

  

X

  

X

 

COST Questionnaire

  

X

 

X

  

X

  

X

  

X

 

CAT Questionnaire

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Hunch survey

   

X

         

X

X

  1. All laboratory tests will be performed at the hospital
  2. 1Only women of child-bearing potential will have a pregnancy test conducted at the screening visit
  3. 2α1-antitrypsin will be measured once at time of enrolment or allocation or at week 4 visit if this has not been performed or documented in the participant’s medical record in the past
  4. 3CT of chest (within the last 1 year) and chest X-ray (during this admission) data will be collected and recorded. If patient has not had CT of chest within the past year or chest X-ray during this admission, it will be requested and ordered by PI or Co-PI. If sinus X-ray results are available within the last year they will be recorded. If participant has not had sinus X-ray completed within the last year it will not be requested or ordered unless participant is symptomatic or suspected to have acute or chronic sinusitis
  5. 4ECG results will be recorded on CRF if available within the last year. If ECG has not been performed within the last year, an ECG will be ordered and conducted by the CIU nurses. Nasopharyngeal swabs and sputum culture data will be recorded if available within the last year. Microbiological studies of respiratory samples (nasopharyngeal swab for viral testing and sputum culture) will not be performed if not already available at time of screening unless clinically indicated
  6. 5SGRQ 4 weeks will be used at allocation and week 4 visit while SGRQ 3 months will be used at week 12, week 24, week 36, and week 48
  7. aResults of PFT in the past 12 months. If not available, conduct a bedside spirometry testing
  8. bExcluding IgG subclass testing
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Pilot and Feasibility Studies

ISSN: 2055-5784