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

NCT04101500 | Unknown Phase 4

• 1 other identifier: 2018S446-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

AECOPD(P+C1)

PLACEBO COMPARATOR

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; Drug: Placebo Tablets

AECOPD(C1+C2)

EXPERIMENTAL

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; Drug: Compound Sodium Chlolate and Aminophylline Tablets(C2)

Interventions

Compound Ipratropium Bromide Solution(C1) for Inhalation DRUG

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

Also known as: CIBS(C1)

AECOPD(C1+C2); AECOPD(P+C1)

Compound Sodium Chlolate and Aminophylline Tablets(C2) DRUG

Applied only to the experimental group.

Also known as: CSCAT(C2)

AECOPD(C1+C2)

Placebo Tablets DRUG

Applied only to the control group.

Also known as: PT

AECOPD(P+C1)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

Study Officials

• Yang Jin

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Jin

CONTACT

027-85726114; whuhjy@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Respiratory and Critical Care Medicine, NHC Key Laboratory of Pulmonary Diseases

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: April 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2024
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

CN (1)