Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT06189586
Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD
A study testing aerosol inhalation of glucocorticoids and intravenous injection of glucocorticoids in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Dong Yang at 1 site in China.
Trial summary
Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- aerosol inhalation of glucocorticoids and intravenous injection of glucocorticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Jul 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AECOPD requiring hospitalization or emergency treatment (COPD acute attacks combined with respiratory failure were eligible). (2) 18 years of age ≤80 years of age (3) Patients and their families are willing to participate in clinical research and sign informed consent.
Who cannot join
- Combined with tuberculosis.
- Combined bronchiectasis.
- complicated with definite infectious diseases.
- PCT≥0.5ng/ml or CRP≥30mg/L.
- Serious injury combined with other organ functions
- Contraindications to other glucocorticoid use.
- Concomitant bronchial asthma or positive bronchodilation test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD-------Multicenter, Prospective, Randomized, Controlled Clinical Study
Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study
Read the detailed description
This study aims to compare the efficacy and comprehensive benefits of aerosol inhalation and intravenous injection of glucocorticoids in severe AECOPD patients.
- Being tested
- aerosol inhalation of glucocorticoids, intravenous injection of glucocorticoids
- Keywords
- severe AECOPD, aerosol inhalation and intravenous glucocorticoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosol inhalation of glucocorticoidsDrug
Patients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation
intravenous injection of glucocorticoidsDrug
Patients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation
| Study group | Role | What they receive |
|---|---|---|
| Nebulized inhalation group | Active comparator | 2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days. Receives: Drug: aerosol inhalation of glucocorticoids |
| Intravenous hormone group | Active comparator | 40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days. Receives: Drug: intravenous injection of glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevant indexes after treatment
Changes in blood gas indexes (oxygenation index, arterial partial pressure of carbon dioxide, pH value) of patients with respiratory rate, blood pressure, heart rate changes
Measured: The day of admission, day one, day two, day three, day five, day seven, day ten
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Description for medicine or protocol of treatment in detail: Dosing regimen: 1. Intravenous hormone group: 40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days. 2. Nebulized inhalation group: 2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin University
- Responsible party
- Sponsor-investigator, Dong Yang, Jilin University
- Investigators
- Dan Li, Doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189586
- Sponsor's protocol ID
- 130064
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD-------Multicenter, Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06189586
- Acronym / sponsor ID
- 130064
- Keywords
- severe AECOPD, aerosol inhalation and intravenous glucocorticoid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dong YangUniversity, hospital or other
- Collaborators
- Jilin University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 Jan 2024 (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.
Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study
Detailed description
This study aims to compare the efficacy and comprehensive benefits of aerosol inhalation and intravenous injection of glucocorticoids in severe AECOPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Description for medicine or protocol of treatment in detail: Dosing regimen: 1. Intravenous hormone group: 40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days. 2. Nebulized inhalation group: 2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Nebulized inhalation group | Active comparator | Drug: aerosol inhalation of glucocorticoids2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days. |
| Intravenous hormone group | Active comparator | Drug: intravenous injection of glucocorticoids40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with AECOPD requiring hospitalization or emergency treatment (COPD acute attacks combined with respiratory failure were eligible). (2) 18 years of age ≤80 years of age (3) Patients and their families are willing to participate in clinical research and sign informed consent.
Key exclusion criteria (7 listed)
- Combined with tuberculosis.
- Combined bronchiectasis.
- complicated with definite infectious diseases.
- PCT≥0.5ng/ml or CRP≥30mg/L.
- Serious injury combined with other organ functions
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 |
|---|---|---|
| aerosol inhalation of glucocorticoidsPatients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation | Drug | Nebulized inhalation group |
| intravenous injection of glucocorticoidsPatients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation | Drug | Intravenous hormone group |
Primary outcome
Relevant indexes after treatment
Time frame: The day of admission, day one, day two, day three, day five, day seven, day ten
Changes in blood gas indexes (oxygenation index, arterial partial pressure of carbon dioxide, pH value) of patients with respiratory rate, blood pressure, heart rate changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Dan Li, Doctor study director
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerosol inhalation of glucocorticoids and intravenous injection of glucocorticoids in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Dong Yang 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 1 inclusion and 7 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 3 Jan 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevant indexes after treatment (time frame: The day of admission, day one, day two, day three, day five, day seven, day ten). 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 3 Jan 2024.