Efficacy and Safety of Yukmijihwang-tang in the Treatment of Cough-Variant Asthma: Study Protocol for a Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

Not Applicable

• Conditions: Diseases of the respiratory system

• Registration Number: KCT0006994
• Lead Sponsor: Daejeon Korean Medicine Hospital of Daejeon University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Men and women aged 19 ~ 65 years
2. Those diagnosed with cough-variant asthma (CVA) by satisfying the following criteria
- chronic cough for more than 8 weeks
- no history of wheezing or dyspnea
- normal FEV1 and FVC (higher than 80% predicted, each)
- airway hyperresponsiveness with a positive bronchial provocation test (Methacholine PC20 <8mg or Mannitol PC15 <635mg)
- no abnormal chest radiographic findings that could be responsible for the cough
3. Those who voluntarily agreed to participate in this clinical study in written form

Exclusion Criteria

1. Those with other causes of chronic cough (ex. chronic sinusitis, allergic rhinitis, gastroesophageal reflux disease, and drug-induced cough)
2. Those who have taken the following medications
- Immunosuppressants or immunomodulators
- within 2 weeks of screening: theophylline
- within 4 weeks of screening: systemic (oral or injection) and topical (inhaled or nasal spray) corticosteroids, leukotriene receptor antagonists, antihistamines, other anti-allergic drugs
- within 12 weeks of screening: anti-IgE antibody, allergen immunotherapy
3. Current smokers (or stop smoking for less than 6 months from screening date)
4. Those who used an asthma treatment other than concomitant medication(Ciclesonide 80µg) and rescue medication(salbutamol sulphate)
5. One or more of the following typical asthma exacerbations during the run-in period
- requires prescription of systemic corticosteroids for at least 3 days
- requires hospitalization for systemic corticosteroid administration due to asthma exacerbation
- requires emergency room visit for systemic corticosteroid administration due to asthma exacerbation
6. Respiratory infection (upper and lower respiratory tract) at a level that requires a change of the asthma treatment stage during the run-in period
7. Those with severe respiratory disease other than asthma (chronic obstructive pulmonary disease, cystic fibrosis, pneumonia, interstitial lung disease, tuberculosis and latent tuberculosis, lung cancer, laryngeal cancer, nasopharyngeal cancer, asthma other than cough-type asthma, etc)
8. Those with clinically significant disorders of the liver, kidney, cardiovascular system, respiratory system, endocrine system, and central nervous system on physical examination and clinical examination or with history of malignant tumors or psychiatric system(However, possible if there is no recurrence for more than 5 years after surgery)
9. Abnormal liver or renal function (ALT, AST, ALP, creatinine values = 2 times the upper limit of normal)
10. Hepatitis A (active) or hepatitis B (active) or hepatitis C
11. History of hypersensitivity reaction to the investigational product
12. Genetic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
13. History of excessive alcohol use or drug addiction
14. Pregnant or lactating women
15. Those who do not use a medically acceptable contraceptive method during the clinical trial period and after 30 days for women and 100 days for men after the last administration of the investigational drug
? Medically acceptable contraceptive method
- use of an intrauterine device with a proven rate of pregnancy failure in the spouse (or partner)
- simultaneous use of barrier contraceptive methods (for men or women) and spermicide
- surgery of yourself or your partner (vasectomy, tubectomy/tubal ligation, hysterectomy)
16. Experience of participating in a different clinical study within 30 days prior to participation in this clinical study
17. Those who were determined to be ineligible to participate in this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the mean Cough Symptom Score(CSS) by week compared to baseline

Secondary Outcome Measures

Name	Time	Method
Changes in the LCQ-K for visit 4 and visit 5 compared to visit 3;Changes in the Eosinophil for visit 5 compared to visit 3;Changes in the ECP(Eosinophil Cationic Protein) for visit 5 compared to visit 3;Changes in the PEFR for visit 5 compared to visit 3;Changes in the FEV1 for visit 5 compared to visit 3;Number of rescue medication use for visit 4 and visit 5 compared to visit 3;IMOS and IMPSS at visit 5(week 6)