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

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 4

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatments: Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation; Drug: Compound Sodium Chlolate and Aminophylline Tablets(C2); Drug: Placebo Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04101500

2018S446-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

AECOPD(P+C1)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Tablets

Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation

AECOPD(C1+C2)

Experimental group

Description:

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.

Treatment:

Drug: Compound Sodium Chlolate and Aminophylline Tablets(C2)

Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation