COPD Acute ExacerbationNCT00274222
The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD
An observational study of COPD Acute Exacerbation, run by Inonu University.
Trial summary
This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD Acute Exacerbation
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Oct 2005
- Phase
- Observational
- 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
- COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study
Who cannot join
- COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.
About this study
This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).
Read the detailed description
Patients, hospitalized with AECOPD, were randomized into three groups. Group I received only bronchodilator treatment (BDT), Group II received SC (40 mg prednisolon) plus BDT, and Group III received nebulized budesonide (NB)(1500 mcg qid) plus BDT. Improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.
- Conditions
- COPD Acute Exacerbation
- Keywords
- COPD, nebulized budesonide, systemic corticosteroids
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJan 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Acute ExacerbationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Observational
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Investigators
- HAKAN GUNEN, MD, Study chair, INONU UNIVERSITY PULMONARY MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274222
- Sponsor's protocol ID
- 2006-3
- Status last verified
- Jan 2006
- First submitted
- 9 Jan 2006
- Last updated
- 10 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT00274222
- Acronym / sponsor ID
- 2006-3
- Conditions
- COPD Acute Exacerbation
- Keywords
- COPD, nebulized budesonide, systemic corticosteroids
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Oct 2005
- First posted
- 10 Jan 2006 (estimated)
- 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.
This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).
Detailed description
Patients, hospitalized with AECOPD, were randomized into three groups. Group I received only bronchodilator treatment (BDT), Group II received SC (40 mg prednisolon) plus BDT, and Group III received nebulized budesonide (NB)(1500 mcg qid) plus BDT. Improvement rates in multiple parameters during 10-day hospitalization, and acute exacerbation and re-hospitalization rates within one-month after discharge were compared between the groups.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study
Key exclusion criteria (1 listed)
- COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2006.
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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.
HAKAN GUNEN, MD study chair
INONU UNIVERSITY PULMONARY MEDICINE
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Acute Exacerbation, run by Inonu University.
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 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: stopped early, as of the sponsor's last update on 10 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. 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.
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 10 Jan 2006.