A randomized, double-blind, placebo-controlled clinical study of gabapentin in the treatment of interstitial pulmonary disease associated refractory cough

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045202

Enrollment

Unknown

Registered

2021-04-08

Start date

2021-05-01

Completion date

Unknown

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

interstitial pulmonary disease associated refractory cough

Interventions

Experimental group:gabapentin

Control group:placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and <= 70 years; 2. Patients in line with ILD, including CTD-ILD, IPAF, IPF; 3. Upper airway cough syndrome, cough-variant asthma and eosinophilic bronchitis cannot be diagnosed according to the medical history and laboratory examination, or the cough cannot be relieved or only partially relieved by treatment for these causes; 4. No contraindication of gabapentin treatment; 5. Be able to read, understand and give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women or those who refuse to sign the informed consent; 2. Smoking or quitting smoking for no more than 2 years; 3. Patients who have used gabapentin within 2 months; 4. A history of respiratory infection within 8 weeks; 5. Patients with acute exacerbation of interstitial pneumonitis (AEIP); 6. Arterial blood gas analysis suggested respiratory failure; 7. With severe heart, liver, kidney and other important organs and blood and endocrine system lesions; 8. With active infection, glucocorticoid and immunosuppressive therapy can aggravate the disease; 9. Hepatitis B virus surface antigen positive or hepatitis C antibody positive; 10. Mentally ill or unable to cooperate with treatment for other reasons; 11. Patients with allergies or allergies to multiple drugs; 12. Other circumstances considered by the researcher to be unsuitable for study participation.

Design outcomes

Primary

Measure	Time frame
Cough symptom score;Leicester Cough Questionnaire;Capsaicin cough sensitivity;	—

Secondary

Measure	Time frame
Activity score of interstitial lung disease;	—

Countries

China

Contacts

Public ContactYu Li

Tongji Hospital, Tongji University School of Medicine

96778@tongji.edu.cn+86 13816699078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 31, 2026