Clinical Study on the Efficacy of Compound Sodium Chlorate and Aminophylline Tablets for Mild to Moderate Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD).
Sponsor study identifier
interventional
200
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
December 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)September 18, 2019
Actual (reported)September 24, 2019
Actual (reported)December 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
COPD assessment test(CAT) score
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.
The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.
Potential of Hydrogen(PH),Partial pressure of oxygen(PO2),Partial pressure of carbon dioxide(PCO2)
Arterial blood gas values were monitored, the values measured at each examination were recorded, and changes between each time were observed.
The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.
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.
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.
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.
The patient's condition and basic condition were the same in the experimental group and the control group.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Yang Jin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
First Submitted
September 18, 2019
First Posted
September 24, 2019
Study Start
April 1, 2019
Actual (reported)Primary Completion
December 30, 2020
Applied only to the experimental group.
Applied only to the control group.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 24, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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