The role of Gabapentin in the treatment of refractory chronic dry cough.

Phase 3

Completed

• Conditions: chronic cough; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12608000248369
• Lead Sponsor: Hunter New England Area Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Persistent non-productive cough of more than 8 weeks duration,
Male or female between ages of 18 and 80 years,
Non-smoker or ex-smoker with less than 10 pack years,
To have been well during the 4 weeks prior to study entry,
Informed consent obtained.

Exclusion Criteria

Productive cough,
Current smoker,
Smoking history >10 pack years,
Pregnancy/breast feeding,
Other respiratory disease, eg: bronchiectasis, COPD.
Inability to attend study visits
Respiratory tract infection during month prior to randomisation
Impaired liver function at Visit 1 as shown by Aspartate aminotransferase (AST), an enzyme normally present in liver and heart cells and alanine aminotransferase (ALT). If the liver is injured, the liver cells spill the enzymes into blood, raising the enzyme levels in the blood and signaling liver damage.
Therefore, an AST, ALT, alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal will exclude a participant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in cough quality of life by Leicester Cough Questionnaire (LCQ)[baseline, during treatment visit (week 8) end of treatment visit (week 12) and post treatment visit (week 16).]

Secondary Outcome Measures

Name	Time	Method
Decrease in cough reflex senstivity[baseline, during treatment visit (week 8), end of treatment visit (week 12) and post treatment visit (week 16).];Decrease in cough frequency by cough monitor recording[baseline, during treatment visit (week 8), end of treatment visit (week 12) and post treatment visit (week 16).];Improvement in cough severity by Cough visual analogue scale (vas)[baseline, during treatment visit (week 8), end of treatment visit (week 12) and post treatment visit (week 16).]