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Clinical Study of Crisugabalin for the Relief of Cough Symptoms in Patients with Cough-Variant Asthma

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Crisugabalin for Rapid Relief of Cough Symptoms in Patients with Cough-Variant Asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129394
Enrollment
Unknown
Registered
2026-08-04
Start date
2026-08-07
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Cough-variant asthma

Interventions

Treatment group:Inhaled glucocorticoids combined with long-acting ß2 receptor agonists (ICS+LABA) were administered for 8 weeks, specifically budesonide formoterol 160 µ g/4.5 µ g, 1 inhalation each t
Control group:Inhaled glucocorticoids combined with long-acting ß2 receptor agonists (ICS+LABA) were administered for 8 weeks, specifically budesonide formoterol 160 µ g/4.5 µ g, 1 inhalation each tim

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70; 2. According to the "Guidelines for the Diagnosis and Treatment of Cough (2021)" issued by the Asthma Group of the Chinese Thoracic Society of the Chinese Medical Association, the diagnostic criteria for cough variant asthma (CVA) are met: cough is the main or sole symptom, often accompanied by obvious nocturnal irritating cough, and the course of the disease is more than 8 weeks. Positive bronchial provocation test, or the average diurnal variation rate of peak expiratory flow rate during the day is greater than 10%, or positive bronchial dilation test; The anti-asthma treatment is effective. 3. Visual Analogue Scale (VAS) for cough >=40mm; 4. Sign the informed consent form and indicate the date.

Exclusion criteria

Exclusion criteria: 1. Those who are currently smoking or have quit smoking for less than two years; 2. Those who have a history of respiratory tract infection in the 8 weeks prior to the assessment; 3. Those with liver or kidney diseases that affect drug metabolism; 4. Those who need to use angiotensin-converting enzyme inhibitors (ACEI) for a long time; 5. Those who have started the treatment of cough with macrolide antibiotics or proton pump inhibitors within 12 weeks before the first administration; 6. Those with hypertension or other cardiovascular system diseases; 7. Those who have contraindications or allergies to the investigational drugs; 8. Those with concurrent mental disorders or drug dependence; 9. Pregnant or lactating women; 10. The researcher determines that there are any other circumstances that make one unsuitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
24-hour cough frequency;

Secondary

MeasureTime frame
daytime and nocturnal cough symptom scores;Cough visual analogue scale (VAS) score;Hull Airway Reflux Questionnaire (HARQ) score;capsaicin cough sensitivity;Leicester Cough Questionnaire (LCQ);Newcastle Laryngeal Hypersensitivity Questionnaire;Depression Screening Scale (PHQ-9);Depression Screening Scale (PHQ-9);Security Index;

Countries

China

Contacts

Public ContactXu Xianghuai

Tongji Hospital of Tongji University

05849@tongji.edu.cn+86 21 66111064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026