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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
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.
Time frame: 2 week
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.
Time frame: 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.
Time frame: 2 week
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