Acute Exacerbation of Chronic Obstructive Pulmonary DiseasePhase 4NCT04101500
Effect of Compound Sodium Chlorate and Aminophylline Tablets on Chronic Obstructive Pulmonary Disease(COPD).
A Phase 4 study testing Compound Ipratropium Bromide Solution(C1) for Inhalation and Compound Sodium Chlolate and Aminophylline Tablets(C2) in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Compound Ipratropium Bromide Solution(C1) for Inhalation and Compound Sodium Chlolate and Aminophylline Tablets(C2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yang Jin, MD
About this study
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).
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.
Read the 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.
- Being tested
- Compound Ipratropium Bromide Solution(C1) for Inhalation, Compound Sodium Chlolate and Aminophylline Tablets(C2), Placebo Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Ipratropium Bromide Solution(C1) for InhalationDrug
Also called CIBS(C1)
The patient's condition and basic condition were the same in the experimental group and the control group.
Compound Sodium Chlolate and Aminophylline Tablets(C2)Drug
Also called CSCAT(C2)
Applied only to the experimental group.
Placebo TabletsDrug
Also called PT
Applied only to the control group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation; Drug: Compound Sodium Chlolate and Aminophylline Tablets(C2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Observe the changes in lung function each time.
Measured: The above test was given to the test group and the control group on the first and eighth days after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Apr 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Yang Jin, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101500
- Sponsor's protocol ID
- 2018S446-1
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04101500
- Acronym / sponsor ID
- 2018S446-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AECOPD(P+C1) | Placebo comparator | Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation, Drug: Placebo TabletsPlacebo 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. |
| AECOPD(C1+C2) | Experimental | Drug: Compound Ipratropium Bromide Solution(C1) for Inhalation, Drug: Compound Sodium Chlolate and Aminophylline Tablets(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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Ipratropium Bromide Solution(C1) for InhalationAlso: CIBS(C1)The patient's condition and basic condition were the same in the experimental group and the control group. | Drug | AECOPD(C1+C2), AECOPD(P+C1) |
| Compound Sodium Chlolate and Aminophylline Tablets(C2)Also: CSCAT(C2)Applied only to the experimental group. | Drug | AECOPD(C1+C2) |
| Placebo TabletsAlso: PTApplied only to the control group. | Drug | AECOPD(P+C1) |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Jin principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Ipratropium Bromide Solution(C1) for Inhalation and Compound Sodium Chlolate and Aminophylline Tablets(C2) in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Jin (027-85726114, whuhjy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.