Back to resultsObservation of Cough Variant Asthma Treated in Combination of Chanqin Granules.
Primary Purpose
Cough Variant Asthma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chanqin granules
Sponsored by
About this trial
This is an interventional treatment trial for Cough Variant Asthma focused on measuring Cough Variant Asthma, impedance, inflammation, Chanqin granules
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
4. 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
Sites / Locations
- Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
treatment group
controlled group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03319043
First Posted
August 20, 2017
Last Updated
October 21, 2017
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03319043
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough Variant Asthma
Keywords
Cough Variant Asthma, impedance, inflammation, Chanqin granules
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
controlled group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Chanqin granules
Other Intervention Name(s)
Budesonide + Formoterol Fumarate, Chanqin granules analogous
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impulse Oscillometry
Description
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
Secondary Outcome Measure Information:
Title
Cough severity
Description
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
Title
Exhaled nitric oxide
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
4. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XUAN CHEN, Master
Phone
+86-13611899735
Email
chen77xuan@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei ZHANG, Master
Phone
+86-13023153956
Email
zhangw1190@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XUAN CHEN, Master
Organizational Affiliation
Shanghai University of T.C.M.
Official's Role
Study Director
Facility Information:
Facility Name
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XUAN XUAN, Master
Phone
+86-13611899735
Email
chen77xuan@aliyun.com
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Master
Phone
+86-13023153956
Email
zhangw1190@sina.com
First Name & Middle Initial & Last Name & Degree
Qi CHEN, Master
First Name & Middle Initial & Last Name & Degree
GuiHua XU, Master
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to these data and associated recommendations generated under the project will be available for educational, research and non-profit purposes.
Citations:
PubMed Identifier
26770777
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.
Results Reference
background
PubMed Identifier
23612495
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.
Results Reference
background
PubMed Identifier
25180727
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.
Results Reference
background
PubMed Identifier
16164444
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.
Results Reference
result
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Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules.
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