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Table 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figures for SYGMA1 (A) and SYGMA2 (B)

From: The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials

 

Enrolment

Run-in

Randomisation

Treatment

Follow-up

A

Week

 

−2 to −4

0

4

16

28

40

52

54

Visit

1

2

3

4

5

6

7

8

Phone

 Informed consent

X

        

 Allocation of enrolment code (IVRS/IWRS)

X

        

 Demography (date of birth, gender, race)

X

        

 Inclusion/exclusion criteria

X

X

X

      

 Medical, surgical history

X

        

 Asthma history (including history of severe asthma exacerbations)

X

        

 Smoking history

X

        

 Patient training in eDiary, Turbuhaler® (inhalation technique), TUM and PEF meter use

 

X

       

 ACQ-5 and AQLQ(S) at study site

 

X

X

Only ACQ-5

X

X

X

X

 

 SAEs (from visit 1)/AEs (from visit 2)

X

X

X

X

X

X

X

X

X

 Weight and height (height only for adolescents at visit 8)

 

X

     

X

 

 Physical examination

 

X

     

X

 

 Pulse and blood pressure

 

X

     

X

 

 Pregnancy test

 

X

       

 Adjustment of current asthma medication

 

X

       

 Randomisation

  

X

      

 Bricanyl® for run-in dispense [d]/return [r]

 

d

r

      

 Lung function (FEV1, FVC pre and post Bricanyl® administration)

 

X

X

X

X

X

X

X

 

 Reversibility test (calculated at visit 2 and if needed, calculated at visit 3 as well)

 

X

X

      

 Concomitant medication

 

X

X

X

X

X

X

X

 

 Investigational product (dispense [d]/return [r]/check [c])

  

d

d/r/c

d/r/c

d/r/c

d/r/c

r/c

 

 Intake of maintenance treatment morning dose

  

X

X

X

X

X

  

 Review of PEF, asthma symptoms, night-time awakenings, maintenance and ‘as needed’ IP intake and Turbuhaler® user technique; re-training of patient if needed

  

X

X

X

X

X

X

 

 Review of patient’s compliance with eDiary

  

X

X

X

X

X

X

 

 Informed consent (qualitative substudy)a

   

Xa

Xa

Xa

Xa

  

B

Week

 

−2 to −4

0

8

17

25

34

42

52b

54

Visit

1

2

3

Phone

 

Phone

 

Phone

  

 Written informed consent

X

         

 Allocation of enrolment code

X

         

 Demography

X

         

 Inclusion/exclusion criteria

X

X

X

       

 Medical/surgical history

X

         

 Asthma history (including exacerbation history)

X

         

 Smoking history

X

         

 ACQ-5, AQLQ(S)

 

X

X

 

X

 

X

 

X

 

 Health Care resource utilisation questionnaire, EQ-5D-5L

  

X

 

X

 

X

 

X

 

 SAE/AEsc

Xc

Xc

X

 

X

 

X

 

X

X

 Weight and height

 

X

      

Xd

 

 Physical examination

 

X

      

X

 

 Vital signs (pulse and blood pressure)

 

X

      

X

 

 Pregnancy test (if applicable)

 

X

        

 Adjustment of current asthma medication

 

X

        

 Patient training in how to use Turbuhaler® (inhalation technique) and TUM

 

X

        

 Bricanyl® for run- in (dispense [d]/return [r])

 

d

r

       

 Randomisation

  

X

       

 Lung function (FEV1, FVC pre and post Bricanyl® administration)

 

X

X

 

X

 

X

 

X

 

 Reversibility teste

 

X

Xe

       

 Collection of severe asthma exacerbations

   

Xf

Xf

Xf

Xf

Xf

Xf

 

 Concomitant medications

 

X

X

 

X

 

X

 

X

 

 Investigational product (dispense [d]/return [r]/check [c])

  

d

 

d/r/c

 

d/r/c

 

r/c

 
  1. Notes:
  2. ACQ-5, Asthma Control Questionnaire 5 questions; AE, adverse event; AQLQ(S), Standardised Asthma Quality of Life Questionnaire; EQ-5D-5L, EuroQol 5-dimensions 5-level; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; IP, investigational product; IWRS/IVRS, Interactive Web and Voice Response System; PEF, morning peak expiratory flow; SAE, serious adverse event; TUM, Turbuhaler® Usage Monitor, recording use of each blinded study inhalers
  3. aObtaining informed consent of patients into the qualitative substudy is only applicable to the subset of sites selected to participate. Informed consent into the substudy is to be obtained before any interview-related activities. Informed consent can occur at any time at visit 4 (week 4) or later; however, the qualitative patient interview conducted with the patient will occur between week 12 and week 50 for each patient who has elected to participate. The exact time point of the interview will be determined by the contract research organisation
  4. bAfter discontinuation of an investigational drug (ie before visit 6) patients will be followed up according to the original visit schedule including site visits and phone contacts. Only severe asthma exacerbations, AEs and concomitant medications will be collected. If it is not possible for the patient to visit the study site, the visit(s) may be performed via phone
  5. cSerious adverse events will be collected from the time of signing informed consent. Adverse events will be collected from visit 2
  6. dHeight only for adolescents
  7. eReversibility test will be performed at visit 2. The test can be repeated at visit 3 in case the patients fail to meet the inclusion criterion at visit 2
  8. fSevere asthma exacerbations will be collected from visit 3 through the entire study
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