refractory chronic cough
Conditions
Interventions
Trial Group:Fufang Keke granule was given 2 bags/time, 3 times/day for 7 days.
Placebo group:Fukang Keke granule placebo was given 2 bags/time, 3 times/day for 7 days.
Sponsors
the First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75; 2. A diagnosis of refractory chronic cough: (1) with cough as the main symptom and a course of =1 year, dry cough with no or little sputum, (2) with no significant abnormalities on chest anterolateral radiographs (or CT) within 6 months, (3) with persistent cough after recommended normative examinations (including upper airway examination or nasopharyngeal or sinus CT without abnormalities, bronchial provocation/relaxation test was negative, sputum eosinophils were normal, and either FeNO was normal, and negative allergy tests such as serum TIgE or specific IgE or allergen skin tests) and treatment (e.g. nasal glucocorticoid plus antihistamines for Upper Airway Cough Syndrome, ICS or ICS + LABA for Cough Variant Asthma or Eosinophilic Bronchitis, ICS + antihistamines for AC, and proton pump inhibitor + prokinetic agent for Gastroesophageal Reflux-related Cough) , the cause remains unknown, (4) with persistent chronic cough after known etiologies for chronic cough (e.g. nasal glucocorticoid plus antihistamines for Upper Airway Cough Syndrome, ICS or ICS + LABA for Cough Variant Asthma or Eosinophilic Bronchitis, ICS + antihistamines for AC, and proton pump inhibitor + prokinetic agent for Gastroesophageal Reflux-related Cough) , (5) some have evidence of chronic cough, but treatment is ineffective and cough persists. 3. cough VAS score >=40; 4. subjects voluntarily participated in the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of upper respiratory tract infection in recent 8 weeks; 2. Axillary temperature > 37 °C; 3. Have other respiratory diseases that may cause cough, such as chronic obstructive pulmonary disease (including chronic bronchitis), bronchiectasis, asthma, lung cancer, tuberculosis, pneumonia, lung abscess, bronchitis, interstitial lung disease, etc.; 4. Current smokers, ex-smokers who have smoked more than 10 pack-years and quit smoking less than half a year; 5. Impairment of liver or kidney function(alanine transaminase(ALT), aspartate transaminase(AST) and alkaline phosphatase (ALP) >=3.0 × ULN, serum creatinine (CR) > 2.0 × ULN, total bilirubin (TBIL) and urea nitrogen (BUN) > 2.0 × ULN; 6. Patients with severe primary diseases such as heart, liver, kidney, digestive and hematopoietic system, or mental diseases; 7. Persons who are allergic to the test drug; 8. Women during pregnancy, lactation and preparation for pregnancy; 9. Participants in clinical trials for other drugs within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of cough visual analogue scale (VAS) improvement >=30 points from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective evaluation of curative effect;Change from baseline in cough visual analogue scale (Vas);Change from baseline in cough evaluation score (CET);Changes from baseline in visual analogue scale (VAS) of pharyngeal symptoms such as pharyngeal itching/pharynx dryness/pharyngeal foreign body sensation;Time to onset of drug action; | — |
Countries
China
Contacts
Public ContactLai Kefang
the First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed