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

NCT ID: NCT03319043

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Cough Variant Asthma

Keywords

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Cough Variant Asthma impedance inflammation Chanqin granules

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Chanqin granules

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Chanqin granules

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Budesonide + Formoterol Fumarate Chanqin granules analogous

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XUAN CHEN, Master

Role: STUDY_DIRECTOR

Shanghai University of T.C.M.

Locations

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Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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XUAN CHEN, Master

Role: CONTACT

Phone: +86-13611899735

Email: [email protected]

Wei ZHANG, Master

Role: CONTACT

Phone: +86-13023153956

Email: [email protected]

Facility Contacts

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XUAN XUAN, Master

Role: primary

Wei Zhang, Master

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26770777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23612495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25180727 (View on PubMed)

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.

Reference Type RESULT
PMID: 16164444 (View on PubMed)

Other Identifiers

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20164Y0199

Identifier Type: -

Identifier Source: org_study_id