AsthmaPhase 4NCT00627731
Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients
A Phase 4 study testing methylprednisolone sodium succinate (mPSL) and prednisolone (PSL) in people with Asthma, run by Hamamatsu University at 1 site in Japan.
Trial summary
A comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. Oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- methylprednisolone sodium succinate (mPSL) and prednisolone (PSL)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2007to Oct 2009
- Phase
- Phase 4
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Asthma patients, who need hospitalized treatment, who do not respond with initial treatment including bronchodilator and IV methylprednisolone therapy
Who cannot join
- Need for incubation
- With severe complications
- Received systemic glucocorticosteroid therapy in the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients
A comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. Oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion.
- Conditions
- Asthma
- Being tested
- methylprednisolone sodium succinate (mPSL), prednisolone (PSL)
- Keywords
- Asthma Patients
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone sodium succinate (mPSL)Drug
Also called methlyprednisolone sodium succinate
mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days
prednisolone (PSL)Drug
Also called prednisolone
PSL 40 mg per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | mPSL 240 mg per day for 5 days Receives: Drug: methylprednisolone sodium succinate (mPSL) |
| 2 | Experimental | PSL 40mg per day for 10 days Receives: Drug: prednisolone (PSL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of oral prednisolone for the treatment of acute asthma
Measured: three-year
Secondary outcomes (1)
The safety of oral prednisolone for the treatment of acute asthma
Measured: three-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naoki Inui, Hamamatsu University
- Investigators
- Kingo Chida, MD,PhD, Study chair, Hamamatsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627731
- Sponsor's protocol ID
- Hamamatsu-18-68
- Other IDs
- Hamamatsu-1968
- Status last verified
- Oct 2009
- First submitted
- 22 Feb 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT00627731
- Acronym / sponsor ID
- Hamamatsu-18-68
- Conditions
- Asthma
- Keywords
- Asthma Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 3 Mar 2008 (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.
A comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. Oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: methylprednisolone sodium succinate (mPSL)mPSL 240 mg per day for 5 days |
| 2 | Experimental | Drug: prednisolone (PSL)PSL 40mg per day for 10 days |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Asthma patients, who need hospitalized treatment, who do not respond with initial treatment including bronchodilator and IV methylprednisolone therapy
Key exclusion criteria (3 listed)
- Need for incubation
- With severe complications
- Received systemic glucocorticosteroid therapy in the previous 4 weeks
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 |
|---|---|---|
| methylprednisolone sodium succinate (mPSL)Also: methlyprednisolone sodium succinatemPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days | Drug | 1 |
| prednisolone (PSL)Also: prednisolonePSL 40 mg per day for 10 days | Drug | 2 |
Primary outcome
Efficacy of oral prednisolone for the treatment of acute asthma
Time frame: three-year
1 secondary outcome
The safety of oral prednisolone for the treatment of acute asthma
Time frame: three-year
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 Sep 2011.
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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.
Kingo Chida, MD,PhD study chair
Hamamatsu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylprednisolone sodium succinate (mPSL) and prednisolone (PSL) in people with Asthma, run by Hamamatsu University at 1 site in Japan.
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 3 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 Sep 2011. 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 Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Efficacy of oral prednisolone for the treatment of acute asthma (time frame: three-year). 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 7 Sep 2011.