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Treatment Outcomes of Nebulized High-Dose Inhaled Corticosteroid as Add-on Therapy in Chronic Obstructive Pulmonary Disease Exacerbation at Emergency Department: A Multicenter Randomized Controlled Trial

Treatment Outcomes of Nebulized High-Dose Inhaled Corticosteroid as Add-on Therapy in Chronic Obstructive Pulmonary Disease Exacerbation at Emergency Department: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250306003
Enrollment
600
Registered
2025-03-06
Start date
2025-03-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation Chronic Obstructive Pulmonary Disease Exacerbation Nebulized High-Dose Inhaled Corticosteroid Emergency department ICS Nebulization

Interventions

Budesonide 2000 mcg (1000 mcg/2 ml, 2 respules) and 1.25 mg fenoterol and 0.5 mg ipratropium bromide q 20 minutes x 3 doses,Normal saline 4 ml and 1.25 mg of fenoterol and 0.5 mg of ipratropium bromid
Experimental Drug,Placebo Comparator Drug

Sponsors

Thai College of Emergency Physicians (TCEP)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Volunteers aged 40 years or older who have been diagnosed with chronic obstructive pulmonary disease (COPD), as evidenced in medical records or the hospital's database system. 2. Having symptoms and signs of exacerbation of chronic obstructive pulmonary disease (COPD), including shortness of breath, rapid breathing, breathing difficulties, chest tightness, coughing, and wheezing.

Exclusion criteria

Exclusion criteria: 1. Presence of respiratory failure with indications for endotracheal intubation in any of the following cases: - Altered of consciousness or restlessness - Air hunger - Cyanosis - Cardiopulmonary arrest 2. Indications for the use of non-invasive ventilation (NIV) in any of the following cases: - Respiratory acidosis, defined as PaCO2 is greater than or equal to 45 mmHg and pH is less than or equal to 7.35 - Severe fatigue with signs of respiratory muscle exhaustion, such as the use of respiratory accessory muscles, respiratory paradox, or intercostal retraction - Persistent hypoxemia despite oxygen therapy 3. Indications for the use of high-flow nasal cannula (HFNC) from the initial presentation when any of the following criteria are met: - Pulse oximetry (SpO2) less than 92% when breathing room air - PaO2/FiO2 (PF) ratio of less than 300 mmHg on any mode of oxygen support - SpO2/FiO2 ratio of less than 315 on any mode of oxygen support 4. History of an allergy to corticosteroids** 5. Suspected or diagnosed infection meeting the criteria for investigation of the 2019 coronavirus disease (COVID-19) 6. Suspected or diagnosed disseminated pulmonary tuberculosis infection 7. Inability to cooperate in pulmonary function testing (e.g., spirometry or peak expiratory flow) 8. Presence of other emergency conditions, such as heart failure, acute myocardial infarction, or shock 9. Use of systemic steroids or an increase in the dosage of inhaled corticosteroids (ICS) within the past 7 days 10. Volunteers diagnosed with asthma-COPD overlap syndrome or bronchiectasis, as documented in medical records

Design outcomes

Primary

MeasureTime frame
Length of hospital stays On the day of hospital discharge Number of days

Secondary

MeasureTime frame
Pulmonary function test (%predicted PEF) At the initial presentation and 1 hour after nebulization for total of 4 hours Spirometry ,Brog dyspnea score At the initial presentation and 1 hour after nebulization for total of 4 hours Brog dyspnea scale

Countries

Thailand

Contacts

Public ContactKumpol Kornthatchapong

Department of Emergency medicine, Faculty of medicine, Thammasat university

kump29@gmail.com029269316

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026