NCT03662269

Indomethacin for Refractory Chronic Cough

Indomethacin for Refractory Chronic Cough: a Randomized, Double-blind, Placebo-controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Chronic cough is a common complain of patients in respiratory clinic and its global prevalence was up to 9.6%. Persistent cough of unexplained origin is a significant health issue that occurs in up to 5% to 10% of patients seeking medical assistance for a chronic cough and from 0% to 46% of patients referred to specialty cough clinics. Previous studies showed that sputum prostaglandin D2( PGD2) and prostaglandin E2 (PGE2) concentrations were significantly higher in chronic cough. And some research showed that Inhaled PGE2 /PGF2α /PGD2 / PGI2/ 6-oxo-PGF1a could induced cough. And PGE2 /PGF2α/PGI2/thromboxane A2 (TXA2) also increased the sensitivity of the cough reflex. All these five primary prostaglandins were synthesized though the metabolism of arachidonic acid via the cyclooxygenase pathway. Indomethacin is a strong inhibitor of cyclooxygenase , which decrease the level of prostaglandins in airway. The investigator's preliminary study showed that indomethacin could relieve cough and improve cough sensitivity of some patients with refractory cough. Therefore this randomized, double-blind, placebo-controlled trial were designed to investigate whether indomethacin can relive cough in patients with refractory cough and to explore the possible mechanism of indomethacin in improving cough in patients with refractory cough.

Conditions

• Refractory Chronic Cough

Interventions

Type	Name	Description
DRUG	indomethacin	indomethacin (75mg, bid, po, 14days)
DRUG	Placebo	placebo (75mg, bid, po, 14days)
DRUG	Omeprazole	placebo (20mg, qd, po, 14days)

Timeline

• Start date: 2018-10-22
• Primary completion: 2020-08-15
• Completion: 2020-12-30
• First posted: 2018-09-07
• Last updated: 2018-11-26

Locations

1 site across 1 country: China