Effect of Compound Sodium Chlorate and Aminophylline Tablets on Chronic Obstructive Pulmonary Disease(COPD).

NCT ID: NCT04101500

Last Updated: 2019-09-24

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-12-30

Brief Summary

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Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an important event in the management of chronic obstructive pulmonary disease. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis.

Detailed Description

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Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an unignorable event in the management of chronic obstructive pulmonary disease. It is crucial to seek for effective management strategy. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis. Compared with the local bronchodilator recommended by the guidelines, it has the advantages of convenient use and good patient compliance. For the purpose of optimize the management of acute exacerbation of chronic obstructive pulmonary disease and provide more convenient options, we compared the efficacy of combined compound sodium chlolate and aminophylline tablets with nebulized ipratropium bromide inhalation plus systemic glucocorticoids in the treatment of chronic obstructive pulmonary disease ranging from moderate degree to severe degree. We hope this research would benefit patients with chronic obstructive pulmonary, especially those in the grassroots.

Conditions

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Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AECOPD(P+C1)

Placebo Tablets(P) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.

Group Type PLACEBO_COMPARATOR

Compound Ipratropium Bromide Solution(C1) for Inhalation

Intervention Type DRUG

The patient's condition and basic condition were the same in the experimental group and the control group.

Placebo Tablets

Intervention Type DRUG

Applied only to the control group.

AECOPD(C1+C2)

Compound Sodium Chlolate and Aminophylline Tablets(C2) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.

Group Type EXPERIMENTAL

Compound Ipratropium Bromide Solution(C1) for Inhalation

Intervention Type DRUG

The patient's condition and basic condition were the same in the experimental group and the control group.

Compound Sodium Chlolate and Aminophylline Tablets(C2)

Intervention Type DRUG

Applied only to the experimental group.

Interventions

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Compound Ipratropium Bromide Solution(C1) for Inhalation

The patient's condition and basic condition were the same in the experimental group and the control group.

Intervention Type DRUG

Compound Sodium Chlolate and Aminophylline Tablets(C2)

Applied only to the experimental group.

Intervention Type DRUG

Placebo Tablets

Applied only to the control group.

Intervention Type DRUG

Other Intervention Names

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CIBS(C1) CSCAT(C2) PT

Eligibility Criteria

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Inclusion Criteria

\- (1)All subjects must sign an informed consent form before participating in the clinical trial.

(2)Clinical diagnosis of AECOPD. (3)Must be able to swallow tablets.

Exclusion Criteria

* (1)Heart disease. (2)Insulin dependent diabetes. (3)Tumor disease. (4)Thyroid disease. (5)Infectious diseases such as hepatitis B, active tuberculosis, etc. (6)Active peptic ulcer. (7)Allergic to related treatments. (8)Participate in other clinical trials within three months. (9)Women who are breast-feeding, pregnant or preparing for pregnancy.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yang Jin

Department of Respiratory and Critical Care Medicine, NHC Key Laboratory of Pulmonary Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Jin

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Jin

Role: CONTACT

027-85726114

Facility Contacts

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Yang Jin, MD

Role: primary

Other Identifiers

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2018S446-1

Identifier Type: -

Identifier Source: org_study_id

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