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

Clinical Study on the Efficacy of Compound Sodium Chlorate and Aminophylline Tablets for Mild to Moderate Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD).

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04101500
Enrollment
200
Registered
2019-09-24
Start date
2019-04-01
Completion date
2024-12-30
Last updated
2019-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Brief summary

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

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.

Interventions

DRUGCompound Ipratropium Bromide Solution(C1) for Inhalation

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

DRUGCompound Sodium Chlolate and Aminophylline Tablets(C2)

Applied only to the experimental group.

DRUGPlacebo Tablets

Applied only to the control group.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
COPD assessment test(CAT) scoreThe above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.Observe the changes in the symptoms of dyspnea each time.The CAT score consists of eight items, each of which has options of 0, 1, 2, 3, 4, and 5. The lower the total score plus the score for the eight items, the lighter the symptoms of COPD.The first item, whether there is cough; the second item, sputum condition; the third item, whether there is chest tightness; the fourth item, when climbing a hill or climbing a layer of stairs, is there any breathlessness;the fifth item, whether chronic obstructive pulmonary disease affects housework; the sixth item, whether it affects going out; the seventh item, sleep situation; the eighth item, whether the energy is sufficient.
Potential of Hydrogen(PH),Partial pressure of oxygen(PO2),Partial pressure of carbon dioxide(PCO2)The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.Arterial blood gas values were monitored, the values measured at each examination were recorded, and changes between each time were observed.

Secondary

MeasureTime frameDescription
Forced Expiratory Volume in the first second (FEV1)/Forced Vital Capacity(FVC)The above test was given to the test group and the control group on the first and eighth days after the treatment.Observe the changes in lung function each time.

Countries

China

Contacts

Primary ContactYang Jin
whuhjy@126.com027-85726114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026