Absence of a clear standard of care and approved drug for chronic cough, the commonest symptom in ILD, calls for further research in this area. In this study, the investigators aim to compare gabapentin and benzonatate treatment with the standard of care for treating chronic cough in ILD. The investigators hypothesize that both gabapentin and benzonatate will be more effective than standard of care in treating chronic cough in ILD.
Established diagnosis of ILD as defined by above
Chronic cough (>= 8 weeks) with NRS ≥ 4/10
On stable treatment for ≥ 8 weeks at screening
Acute respiratory infection or ILD exacerbation leading to hospitalization within past 8 weeks of screening.
Exposure to Gabapentin/Benzonatate within past 4 weeks
Gastroesophageal reflux disease
Upper airway cough syndrome
Parallel
Gabapentin
DrugGabapentin at starting dose of 100 mg per dose, thrice daily and up titrated by 100 mg per dose every 3 days till 300 mg per dose, thrice daily or maximum tolerated dose
Benzonatate 200 mg
DrugBenzonatate at starting dose of 100 mg per dose thrice daily and up titrated to 200 mg per dose thrice daily after 3 days
Standard of care treatment for ILD
Other interventionStandard Therapy including immunosuppressive and/or anti-fibrotic agent/s and symptomatic therapy for cough (as needed dextromethorphan lozenges)
Cough intensity in Gabapentin group
Difference in change in numerical rating scale (NRS 0-10) for cough from baseline to 8 weeks between the gabapentin and the standard of care groups.The cough numerical rating scale (NRS) is a simple, self-reported tool used to measure chronic cough severity, frequency, or the urge to cough on an 11-point scale from 0 to 10. 0: No cough (or no symptoms at all). 10: The most severe or worst possible cough imaginable. Higher scores: Indicate worse symptoms and greater severity.
Cough intensity in benzonatate arm
Difference in change in numerical rating scale (NRS 0-10) for cough from baseline to 8 weeks between the benzonatate and the standard of care groups. The cough numerical rating scale (NRS) is a simple, self-reported tool used to measure chronic cough severity, frequency, or the urge to cough on an 11-point scale from 0 to 10. 0: No cough (or no symptoms at all). 10: The most severe or worst possible cough imaginable. Higher scores: Indicate worse symptoms and greater severity.
Cough VAS in gabapentin group
Difference in the change in the visual analog scale (VAS) score for cough at 8 weeks between gabapentin and standard of care groups. The cough severity visual analog scale (VAS) is a 100-millimeter linear line that lets patients rate their cough intensity from \[0 mm ("no cough")\] to \[100 mm ("worst imaginable cough")\]. Format: A straight horizontal or vertical line measuring exactly 100 mm long. Anchors: The bottom or left end is marked 0 ("No cough"), and the top or right end is marked 100 ("Worst cough"). Scoring: The patient makes a mark on the line matching their symptom severity, and the distance in millimeters from zero to the mark is measured. Higher scores indicate worse cough.
Cough VAS in benzonatate arm
Difference in the change in the visual analog scale (VAS) score for cough at 8 weeks between benzonatate and standard of care groups. The cough severity visual analog scale (VAS) is a 100-millimeter linear line that lets patients rate their cough intensity from \[0 mm ("no cough")\] to \[100 mm ("worst imaginable cough")\]. Format: A straight horizontal or vertical line measuring exactly 100 mm long. Anchors: The bottom or left end is marked 0 ("No cough"), and the top or right end is marked 100 ("Worst cough"). Scoring: The patient makes a mark on the line matching their symptom severity, and the distance in millimeters from zero to the mark is measured. Higher scores indicate worse cough.
Leicester Cough questionnaire (LCQ) score in gabapentin arm
Difference in the change in leicester cough questionnaire (LCQ) total score at 8 weeks between gabapentin and standard of care groups.The Leicester Cough Questionnaire (LCQ) is a brief, 19-item self-administered tool used to measure the impact of a chronic cough on an adult's quality of life over the previous two weeks. The questionnaire splits the 19 items into three specific areas of health: Physical (8 items): Evaluates chest or stomach pains, phlegm, hoarseness, sleep disruption, energy levels, and coughing bouts. Psychological (7 items): Measures tiredness, feelings of control, embarrassment, anxiety, frustration, and worry about serious illness. Social (4 items): Assesses interference with jobs, daily enjoyment, conversations, and relationships. Scoring and Interpretation: Scale: Each item is rated on a 7-point Likert scale (ranging from 1 to 7). Total Score Range: From 3 to 21. Higher scores indicate a better quality of life and less impact from the cough
Leicester Cough questionnaire score in the benzonatate arm
Difference in the change in leicester cough questionnaire (LCQ) total score at 8 weeks between benzonatate and standard of care groups.The Leicester Cough Questionnaire (LCQ) is a brief, 19-item self-administered tool used to measure the impact of a chronic cough on an adult's quality of life over the previous two weeks. The questionnaire splits the 19 items into three specific areas of health: Physical (8 items): Evaluates chest or stomach pains, phlegm, hoarseness, sleep disruption, energy levels, and coughing bouts. Psychological (7 items): Measures tiredness, feelings of control, embarrassment, anxiety, frustration, and worry about serious illness. Social (4 items): Assesses interference with jobs, daily enjoyment, conversations, and relationships. Scoring and Interpretation: Scale: Each item is rated on a 7-point Likert scale (ranging from 1 to 7). Total Score Range: From 3 to 21. Higher scores indicate a better quality of life and less impact from the cough
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