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Table 1 Schedule of study assessments

From: Use of low-dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

Assessment

Recruitment

2 weeks (phone)

Month 6 (face to face)

Month 12 (face to face)

Post-study GP records

Assessment of eligibility criteria

X

    

Written informed consent

X

    

Clinical history

X

    

Drug history

X

 

X

X

 

Smoking status

X

X

X

X

 

Height

X

    

Weight

X

 

X

X

 

Total number COPD exacerbations requiring oral corticosteroids/antibiotics

  

X

X

X

Hospital admissions

  

X

X

X

Health-related quality of life (EQ-5D)

X

 

X

X

 

Disease-related health status (CAT, MRC dyspnoea)

X

 

X

X

 

Post-bronchodilator lung function

X

 

X

X

 

Adverse events/drug reactions

 

X

X

X

 

Health-care utilisation

  

X

X

 

Patient compliance

  

X

X

 
  1. X boxes represent which aspect of the assessment is conducted. CAT COPD (Chronic Obstructive Pulmonary Disease) Assessment Test, COPD Chronic obstructive pulmonary disease, EQ-5D EuroQOL five-dimension questionnaire, GP General practitioner, MRC Medical Research Council
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Trials

ISSN: 1745-6215