Sponsor study identifier
interventional
177
1 country
1
Study Start
October 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2026
Actual (reported)October 6, 2026
Actual (reported)October 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
8 weeks
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.
8 weeks
Cough VAS in gabapentin group
8 weeks
Cough VAS in benzonatate arm
8 weeks
Leicester Cough questionnaire (LCQ) score in gabapentin arm
8 weeks
Leicester Cough questionnaire score in the benzonatate arm
8 weeks
ILD-related quality of life assess using the King's brief interstitial lung disease score in gabapantin arm
8 weeks
Participants will be treated with 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. Standard Therapy including anti-fibrotic agent/s, immunosuppression therapy and symptomatic therapy for cough as per departmental treatment protocol (as needed dextromethorphan lozenges) shall be continued.
Participants will be treated with 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 Therapy including anti-fibrotic agent/s, immunosuppression therapy and symptomatic therapy for cough as per departmental treatment protocol (as needed dextromethorphan lozenges) shall be continued.
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 at starting dose of 100 mg per dose thrice daily and up titrated to 200 mg per dose thrice daily after 3 days
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012, India
Sahajal Dhooria, MD, DM
Postgraduate Institute of Medical Education and Research, Chandigarh, India
First Submitted
September 30, 2026
First Posted
October 6, 2026
Study Start
October 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of the Reproducibility of the Automated Measurement of the Extent of ILD on Chest CT
Standard Therapy including immunosuppressive and/or anti-fibrotic agent/s and symptomatic therapy for cough (as needed dextromethorphan lozenges)
Standard Therapy including immunosuppressive and/or anti-fibrotic agent/s and symptomatic therapy for cough (as needed dextromethorphan lozenges)
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Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
Deidentified data related to study's primary and secondary outcomes
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Source: ClinicalTrials.gov.
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