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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101500
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yang Jin, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation Drug: Compound Sodium Chlolate and Aminophylline Tablets(C2) Drug: Placebo Tablets Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study on the Efficacy of Compound Sodium Chlorate and Aminophylline Tablets for Mild to Moderate Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD).
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Placebo Comparator: 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.
Drug: 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.
Other Name: CIBS(C1)

Drug: Placebo Tablets
Applied only to the control group.
Other Name: PT

Experimental: 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.
Drug: 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.
Other Name: CIBS(C1)

Drug: Compound Sodium Chlolate and Aminophylline Tablets(C2)
Applied only to the experimental group.
Other Name: CSCAT(C2)




Primary Outcome Measures :
  1. COPD assessment test(CAT) score [ Time Frame: The 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.

  2. Potential of Hydrogen(PH),Partial pressure of oxygen(PO2),Partial pressure of carbon dioxide(PCO2) [ Time Frame: 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 Outcome Measures :
  1. Forced Expiratory Volume in the first second (FEV1)/Forced Vital Capacity(FVC) [ Time Frame: 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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101500


Contacts
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Contact: Yang Jin 027-85726114 whuhjy@126.com

Locations
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China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430000
Contact: Yang Jin, MD         
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Principal Investigator: Yang Jin Wuhan Union Hospital, China

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Responsible Party: Yang Jin, Department of Respiratory and Critical Care Medicine, NHC Key Laboratory of Pulmonary Diseases, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04101500    
Other Study ID Numbers: 2018S446-1
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Aminophylline
Bromides
Ipratropium
Pharmaceutical Solutions
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Protective Agents