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

Cough Variant Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03319043
• Other study ID #: 20164Y0199
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 20, 2017
• Last updated: October 21, 2017
• Start date: November 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2016
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: XUAN CHEN, Master
• Phone: +86-13611899735
• Email: chen77xuan[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Cough
• Cough Variant Asthma

Intervention

Drug:
• Chanqin granules
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.

Locations

Country	Name	City	State
China	Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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