A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic Cough (RCC/UCC).

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.

About this trial

This is a randomized, multicenter, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HW091077 in Chinese adult subjects with refractory chronic cough or unexplained chronic cough (RCC/UCC).

Eligibility criteria

Qualifiers

Aged between 18 and 80 years;

Diagnosed with refractory chronic cough or unexplained chronic cough, with a cough lasting for ≥1 year;

Chest CT at screening shows no abnormalities that the investigator believes may lead to chronic cough;

Cough severity VAS score ≥40 mm ;

Disqualifiers

Currently smoking, or having quit smoking within 12 months prior to screening;

A smoking history of >20 pack-years;

Ongoing exposure to inhaled toxic substances within 12 months prior to screening or currently;

A history of drug abuse or alcoholism (weekly alcohol consumption of 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);

Trial design

Treatments tested in this trial

  • HW091077
  • HW091077
  • Matching placebo to HW091077

Treatment groups

180 Participants
are divided into 3 treatment groups

Locations

This trial has no locations