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Enrolling by invitationNCT06189586Updated Jan 3, 2024

Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD

An interventional study of aerosol inhalation of glucocorticoids and intravenous injection of glucocorticoids in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, sponsored by Dong Yang. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Dong Yang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 2 years 2 months after the study started (first participant enrolled Oct 2021, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

  • severe AECOPD
  • aerosol inhalation and intravenous glucocorticoid
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In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Dong Yang is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

(1) 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.

Exclusion criteria

Exclusion Criteria:

  1. Combined with tuberculosis.
  2. Combined bronchiectasis.
  3. complicated with definite infectious diseases.
  4. PCT≥0.5ng/ml or CRP≥30mg/L.
  5. Serious injury combined with other organ functions
  6. Contraindications to other glucocorticoid use.
  7. Concomitant bronchial asthma or positive bronchodilation test
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Nebulized inhalation group

    2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.

    Drug: aerosol inhalation of glucocorticoids

  • Active comparator
    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.

    Drug: intravenous injection of glucocorticoids

Interventions

  • Drugaerosol inhalation of glucocorticoids

    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

  • Drugintravenous injection of glucocorticoids

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: The day of admission, day one, day two, day three, day five, day seven, day ten

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Study locations

1 site
  • The First Hospital of Jilin University
    Changchun, Ji Lin 130021, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06189586
Lead sponsor
Dong Yang
Collaborators
Jilin University
Responsible party
Dong Yang (Assisted Investigator, Jilin University) — Sponsor-investigator
First posted
Jan 3, 2024
Start date
Oct 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Jan 3, 2024

Study contacts

Dan Li, Doctor
study director · The First Hospital of Jilin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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