Clinical trial NCT03319043: Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules.
Official title: Observation of the Respiratory Impedance and Inflammation in Cough Variant Asthma Patients Treated in Combination of Chanqin Granules.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cough Variant Asthma
Keywords: Cough Variant Asthma
impedance
inflammation
Chanqin granules
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of cough variant asthma according to Western medicine
2. Diagnosis of cough with pathogenic wind syndrome according to TCM
3. Aged between 18 to 70 years, regardless of gender, race or educational and economic status
4. The cough symptom should last for at least 8 weeks

4. Willingness to participate and to sign the informed consent form

Exclusion Criteria:

1. Patients with history of smoking (or quite smoking for less than 6 months)
2. Systemic use of corticosteroids in the past 4 weeks
3. Upper or lower respiratory tract infection in the past 4 weeks
4. Incapable of corporation with spirometry and FeNO test
5. Other chronic respiratory disease eg: COPD, pulmonary cirrhosis
6. Women who are pregnant or preparing to become pregnant or breast feeding women

Primary outcomes:
measure: Impulse Oscillometry
timeFrame: 2 week
Secondary outcomes:
measure: Cough severity
timeFrame: 2 week
measure: Exhaled nitric oxide
timeFrame: 2 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of T.C.M.
name: XUAN CHEN, Master
role: STUDY_DIRECTOR
References:
citation: Saadeh C, Saadeh C, Cross B, Gaylor M, Griffith M. Advantage of impulse oscillometry over spirometry to diagnose chronic obstructive pulmonary disease and monitor pulmonary responses to bronchodilators: An observational study. SAGE Open Med. 2015 Apr 6;3:2050312115578957. doi: 10.1177/2050312115578957. eCollection 2015.
citation: Shimoda T, Obase Y, Kishikawa R, Iwanaga T, Miyatake A, Kasayama S. The fractional exhaled nitric oxide and serum high sensitivity C-reactive protein levels in cough variant asthma and typical bronchial asthma. Allergol Int. 2013 Jun;62(2):251-7. doi: 10.2332/allergolint.12-OA-0515. Epub 2013 Apr 25.
citation: Bickel S, Popler J, Lesnick B, Eid N. Impulse oscillometry: interpretation and practical applications. Chest. 2014 Sep;146(3):841-847. doi: 10.1378/chest.13-1875.
citation: Berry MA, Shaw DE, Green RH, Brightling CE, Wardlaw AJ, Pavord ID. The use of exhaled nitric oxide concentration to identify eosinophilic airway inflammation: an observational study in adults with asthma. Clin Exp Allergy. 2005 Sep;35(9):1175-9. doi: 10.1111/j.1365-2222.2005.02314.x.