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

NCT03319043 | Unknown Phase 1 DMC

• 1 other identifier: 20164Y0199
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough Variant Asthma

Keywords

Cough Variant Asthma; impedance; inflammation; Chanqin granules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cough severity

  2 week

• Exhaled nitric oxide

  2 week

Study Arms (2)

treatment group

EXPERIMENTAL

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

controlled group

PLACEBO COMPARATOR

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

Interventions

Chanqin granules DRUG

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.

Also known as: Budesonide + Formoterol Fumarate, Chanqin granules analogous

controlled group; treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

Related Publications (4)

• 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.

  PMID: 26770777 BACKGROUND

• 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.

  PMID: 23612495 BACKGROUND

• 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.

  PMID: 25180727 BACKGROUND

• 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.

  PMID: 16164444 RESULT

MeSH Terms

Conditions

Cough-Variant Asthma; Inflammation

Interventions

Budesonide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• XUAN CHEN, Master

  Shanghai University of T.C.M.

  STUDY DIRECTOR

Central Study Contacts

XUAN CHEN, Master

CONTACT

+86-13611899735; chen77xuan@aliyun.com

Wei ZHANG, Master

CONTACT

+86-13023153956; zhangw1190@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization sequences will be concealed in lightproof, sealed envelopes kept by a specified project manager and the sponsor, who are not involved in the recruitment, intervention, assessment, or statistical analysis. The treatment allocation will be blinded to the participants and investigators throughout the study, and the outcome assessors and statisticians will not be involved in the participants' screening and allocation. Each patient will receive a unique randomized number corresponding to the drug according to the group allocation. Furthermore, the intervention group type will be replaced by the letter A, B as blind codes of allocation. The blind codes will not be disclosed until the statistical analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: October 24, 2017
• Study Start: November 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: June 30, 2019
• Last Updated: October 24, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)