Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules.

Study Overview
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Brief Summary
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This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. Clinical observation of the Respiratory Impedance and Inflammation in Cough Variant Asthma adults reated in Combination of Chanqin Granules.

Detailed Description
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This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. All patients enrolled are treated with Budesonide + Formoterol Fumarate dry power (160/4.5ug bid) for inhalation. The treatment group are given additional Chanqin granulate (10g bid) and placebo granulate for controlled group. Investigators hypothesis that Chanqin granules may reduce day & night cough score as well as the respiratory impedance, inflammation statues, and improve T.C.M. syndrome after 8 weeks of treatment.

Official Title
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Observation of the Respiratory Impedance and Inflammation in Cough Variant Asthma Patients Treated in Combination of Chanqin Granules.

Conditions
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Cough Variant Asthma

Intervention / Treatment
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* Drug: Chanqin granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cough variant asthma according to Western medicine Diagnosis of cough with pathogenic wind syndrome according to TCM Aged between 18 to 70 years, regardless of gender, race or educational and economic status The cough symptom should last for at least 8 weeks 4. Willingness to participate and to sign the informed consent form Exclusion Criteria: Patients with history of smoking (or quite smoking for less than 6 months) Systemic use of corticosteroids in the past 4 weeks Upper or lower respiratory tract infection in the past 4 weeks Incapable of corporation with spirometry and FeNO test Other chronic respiratory disease eg: COPD, pulmonary cirrhosis Women who are pregnant or preparing to become pregnant or breast feeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 120 eligible participants will be randomly allocated to the placebo group and treatment group in a 1:1 ratio. Randomized sequences of each center and every packed drug were generated by an independent professor at the Drug Clinical Research Center of Shanghai University of TCM, using a stratified block randomization method with 30 blocks of block size 8 based on the PROC PLAN function of the SAS 9.2 software analysis system (SAS Institute, Cary, NC, USA).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>patients are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation and additional Chanqin granules 10g three times a day. All granules will be taken orally with 200 ml warm water. | Drug: Chanqin granules<br>* All patients enrolled in the research are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation. Patients in treatment group are given additional Chanqin granules 10g three times a day; and analogous for the controlled group.<br>* Other names: Chanqin granules analogous;|
| Placebo Comparator: controlled group<br>patients enrolled in the research are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation and Chanqin analogous granules. All granules will be taken orally with 200 ml warm water. | Drug: Chanqin granules<br>* All patients enrolled in the research are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation. Patients in treatment group are given additional Chanqin granules 10g three times a day; and analogous for the controlled group.<br>* Other names: Chanqin granules analogous;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impulse Oscillometry | The patients will be seated comfortably in a nonswivel chair. Nose clips were applied and a special mouthpiece will be used. For Impulse Oscillometry measurements (MasterScreen, CareFusion, San Diego, California) are performed according to the protocols of the European Respiratory Society. Patients will be advised to cradle their cheeks with their hands. Patients are allowed to breathe normally while the loudspeaker delivere intermittent multi-frequency impulses over a minimum of a 30-s period. A trained technician will guide and assist the patient during the procedure, which involved three to five sinusoidal readings, depending on the incidence of cough, swallowing, and holding of breath. The recordings with the best coherence at frequencies from 5 to 30 Hz will be chosen. The technician is also trained to capture subclinical leaks through the mouthpiece, and leaky recordings will be discarded. The Impulse Oscillometry parameters measured are Zrs、R5、R20、X5. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough severity | Cough severity is measured by a validated verbal category-descriptive (VCD) scores which patients reported. =The scale has 6 discrete values: 0=no cough; 1=one short period of mild cough without hardship; 2=some short periods of cough without much hardship; 3=frequent coughing that does not affect normal daily life or sleep; 4=serious coughing that is very frequent and interferes with normal daily life or sleep; 5=distressing continuous coughing that did not stop for 24 h. | 2 week | 
| Exhaled nitric oxide | Exhaled nitric oxide is measured using a portable analyzer, the NIOX MINO (Aerocrine AB, Solna, Sweden). Participants performe a 10 seconds slow steady exhalation. Three successive recordings at 1-minute intervals, expressed as parts per billion (ppb), are made. | 2 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cough Variant Asthma, impedance, inflammation, Chanqin granules