Gabapentin vs. Benzonatate vs. Standard of Care for Cough in ILD

NCT07859839 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Phase 4

Started

2026-10-07

Last updated

2026-10-08

Condition(s) studied

Interstitial Lung Disease

Investigational drug(s) / intervention(s)

Gabapentin →Benzonatate 200 mgStandard of care treatment for ILD

Gabapentin: Gabapentin 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: Benzonatate 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: Standard Therapy including immunosuppressive and/or anti-fibrotic agent/s and symptomatic therapy for cough (as needed dextromethorphan lozenges)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Established diagnosis of ILD as defined by above 2. Chronic cough (\>= 8 weeks) with NRS ≥ 4/10 3. On stable treatment for ≥ 8 weeks at screening 5\. No contraindication to Gabapentin or Benzonatate Therapy Exclusion Criteria: 1. Acute respiratory infection or ILD exacerbation leading to hospitalization within past 8 weeks of screening. 2. Exposure to Gabapentin/Benzonatate within past 4 weeks 3. Gastroesophageal reflux disease 4. Upper airway cough syndrome 5. Pregnant or Lactating women 6. Decompensated Heart Failure (New York Heart Association (NYHA) Class III/IV) 7. Renal Impairment (eGFR \< 30ml/min/1.73m2) 8. Chronic liver disease (Child-Pugh class B or C) 9. Known hypersensitivity to Gabapentin or Benzonatate 10. Co-morbid bronchial asthma or chronic obstructive pulmonary disease (COPD) 11. Long term oxygen therapy (LTOT)

Primary outcome measure(s)

Cough intensity in Gabapentin group — 8 weeks
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 — 8 weeks
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.

Trial sites (1)

Facility	City	Region	Status
Postgraduate Institute of Medical Education and Research	Chandigarh	Chandigarh

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