Chronic Obstructive Pulmonary DiseaseNCT01215825
The Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
It is well established that steroid use is a benefit in the treatment of chronic obstructive pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the regimen and dosage of steroid use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 164 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Jul 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)
Who may be able to join
- From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Therapeutic Impact of Various Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
It is well established that steroid use is a benefit in the treatment of chronic obstructive pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the regimen and dosage of steroid use. From this retrospective review of medical charts, the researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.
Read the detailed description
Data collection from medical charts was conducted at Far Eastern Memorial Hospital, a tertiary-care hospital with around 900 beds. Patients who were admitted from January 2008 to December 2008 and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21) were included in this study. The study was approved by the Institutional Review Board of the Far Eastern Memorial Hospital (FEMH:098097-3).
Demographic data, medical histories and medicine prescriptions at outpatient clinics, emergency and inpatient departments were collected. The initial presentations of acute exacerbation and laboratory data were also summarized from the records of the emergency department. The reports of pulmonary function tests within 6 months before or after the exacerbations were included while reviewing the charts. The probability of concomitant pneumonia (pAECOPD) was determined by attending physicians and reviewed by the investigator according to the radiologic findings. If there were incoherent opinions about the probability of pneumonia between the physicians and the investigator, it was determined by another independent pulmonologist. The highest daily doses and total doses of systemic steroids were calculated and recorded as the equivalent doses of prednisolone (1 mg methylprednisolone is equal to 1.25 mg prednisolone; 1 mg hydrocortisone is equal to 0.25 mg prednisolone). The subjects were divided into 3 groups according to the highest daily dose of steroids as follows: patients receiving more than 60 mg/day were designated to the HD group; those receiving less than or equal to 60 mg/day to the LD group; and those who did not receive any steroids during admission to the NIL group. The length of stay (LOS) was defined as the duration from admission to the emergency department to discharge. Hyperglycemia, psychosis, nosocomial infections and active peptic ulcer diseases were regarded as acute side effects of systemic steroids. Hyperglycemia was defined as a new blood sugar level of more than 200 mg/dl in patients without a history of diabetic mellitus, or an increment in diabetes medications. The relapse rate within 30 days was assessed by outpatient follow-up records.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, systemic steroid
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HD, LD, NIL | HD: the highest daily dose of steroids receiving more than 60 mg/day LD: the highest daily dose of steroids receiving less or equal to 60 mg/day NIL: no steroid use |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-huai Wang, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215825
- Sponsor's protocol ID
- 098097-3
- Status last verified
- Jan 2010
- First submitted
- 5 Oct 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Impact of Various Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01215825
- Acronym / sponsor ID
- 098097-3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, systemic steroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Oct 2010 (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.
It is well established that steroid use is a benefit in the treatment of chronic obstructive pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the regimen and dosage of steroid use. From this retrospective review of medical charts, the researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.
Detailed description
Data collection from medical charts was conducted at Far Eastern Memorial Hospital, a tertiary-care hospital with around 900 beds. Patients who were admitted from January 2008 to December 2008 and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21) were included in this study. The study was approved by the Institutional Review Board of the Far Eastern Memorial Hospital (FEMH:098097-3).
Demographic data, medical histories and medicine prescriptions at outpatient clinics, emergency and inpatient departments were collected. The initial presentations of acute exacerbation and laboratory data were also summarized from the records of the emergency department. The reports of pulmonary function tests within 6 months before or after the exacerbations were included while reviewing the charts. The probability of concomitant pneumonia (pAECOPD) was determined by attending physicians and reviewed by the investigator according to the radiologic findings. If there were incoherent opinions about the probability of pneumonia between the physicians and the investigator, it was determined by another independent pulmonologist. The highest daily doses and total doses of systemic steroids were calculated and recorded as the equivalent doses of prednisolone (1 mg methylprednisolone is equal to 1.25 mg prednisolone; 1 mg hydrocortisone is equal to 0.25 mg prednisolone). The subjects were divided into 3 groups according to the highest daily dose of steroids as follows: patients receiving more than 60 mg/day were designated to the HD group; those receiving less than or equal to 60 mg/day to the LD group; and those who did not receive any steroids during admission to the NIL group. The length of stay (LOS) was defined as the duration from admission to the emergency department to discharge. Hyperglycemia, psychosis, nosocomial infections and active peptic ulcer diseases were regarded as acute side effects of systemic steroids. Hyperglycemia was defined as a new blood sugar level of more than 200 mg/dl in patients without a history of diabetic mellitus, or an increment in diabetes medications. The relapse rate within 30 days was assessed by outpatient follow-up records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD, LD, NIL | – | –HD: the highest daily dose of steroids receiving more than 60 mg/day LD: the highest daily dose of steroids receiving less or equal to 60 mg/day NIL: no steroid use |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)
Key inclusion criteria (1 listed)
- From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)
Key exclusion criteria (1 listed)
- -
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.
2 secondary outcomes
side effects
Time frame: 2009
30-day relapse rates
Time frame: 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Ping-huai Wang, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 7 Oct 2010. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 7 Oct 2010.