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

Shanghai University of Traditional Chinese Medicine1 site in 1 country120 target enrollmentNovember 1, 2017

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2017

End Date

June 30, 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai University of Traditional Chinese Medicine

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Arms & Interventions

treatment group

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.

Intervention: Chanqin granules

controlled group

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.

Intervention: Chanqin granules

Outcomes

Primary Outcomes

Impulse Oscillometry

Time Frame: 2 week

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.