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Table 1 Outline of the planned visit

From: The efficacy of gabapentin for the treatment of refractory cough associated with interstitial lung disease: study protocol for a randomized, double-blind and placebo-controlled clinical trial

 

Study period

 

Screening visit

Randomize

Treatment visits

Post-treatment follow-up

Timepoint**

−7~0

 

Visit 1

Day 0

Visit 2

Week 4

Visit 3

Week 8

Visit 4

Week 10

Visit 5

Week 14

Eligibility screen

X

      

Informed consent

X

      

Adverse event check

  

X

X

X

X

X

Study drug

  

X

X

X

X

 

Concomitant medication

  

X

X

X

X

X

Assessments

       

 Physical exam

X

      

 Cough symptom score

X

 

X

X

X

X

X

 LCQ

X

 

X

X

X

X

X

 Gerd Q

X

 

X

X

X

X

X

 HARQ

X

 

X

X

X

X

X

 Capsaicin cough sensitivity

X

 

X

X

X

X

X

 Induced sputum analysis

X

 

X

X

X

X

X

 Pulmonary function

X

 

X

   

X

 Chest CT

X

 

X

   

X

  1. LCQ, Leicester Quality of Life Questionnaire, Gerd Q, Gastroesophageal Reflux Disease Questionnaire, HARQ, Hull Airway Reflux Questionnaire, Chest CT, chest computer tomography
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Trials

ISSN: 1745-6215