Eosinophilic PneumoniaPhase 4NCT00632554
The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
A Phase 4 study testing prednisolone 0.5 mg/kg/day for three months and prednisolone 0.5 mg/kg/day for six months in people with Eosinophilic Pneumonia and Chronic Disease, run by Hamamatsu University at 1 site in Japan.
Trial summary
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Eosinophilic Pneumonia, Chronic Disease
- What is being tested?
- prednisolone 0.5 mg/kg/day for three months and prednisolone 0.5 mg/kg/day for six months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2008to Mar 2010
- 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
- Biopsy-proven chronic eosinophilic pneumonia
Who cannot join
- Patients who received oral glucocorticosteroid (more than 10 mg)
- Immunosuppressive drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.
- Conditions
- Eosinophilic Pneumonia, Chronic Disease
- Being tested
- prednisolone 0.5 mg/kg/day for three months, prednisolone 0.5 mg/kg/day for six months
- Medical subject headings
- Pulmonary Eosinophilia, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisolone 0.5 mg/kg/day for three monthsDrug
Also called prednisolone
period of treatment
prednisolone 0.5 mg/kg/day for six monthsDrug
Also called prednisolone
period of therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | prednisolone therapy for three months Receives: Drug: prednisolone 0.5 mg/kg/day for three months |
| 2 | Active comparator | prednisolone therapy for six months Receives: Drug: prednisolone 0.5 mg/kg/day for six months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Measured: Three years
Secondary outcomes (1)
Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic PneumoniaStudies 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 (estimated)
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
- NCT00632554
- Sponsor's protocol ID
- Hamamatsu-18-67
- Status last verified
- Sep 2014
- First submitted
- 28 Feb 2008
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oyama Y, Fujisawa T, Hashimoto D, Enomoto N, Nakamura Y, Inui N, Kuroishi S, Yokomura K, Toyoshima M, Yamada T, Shirai T, Masuda M, Yasuda K, Hayakawa H, Chida K, Suda T. Efficacy of short-term prednisolone treatment in patients with chronic eosinophilic pneumonia. Eur Respir J. 2015 Jun;45(6):1624-31. doi: 10.1183/09031936.00199614. Epub 2015 Jan 22.
PubMed 25614171
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia
- ClinicalTrials.gov ID
- NCT00632554
- Acronym / sponsor ID
- Hamamatsu-18-67
- Conditions
- Eosinophilic Pneumonia, Chronic Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 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 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: prednisolone 0.5 mg/kg/day for three monthsprednisolone therapy for three months |
| 2 | Active comparator | Drug: prednisolone 0.5 mg/kg/day for six monthsprednisolone therapy for six months |
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)
- Biopsy-proven chronic eosinophilic pneumonia
Key exclusion criteria (2 listed)
- Patients who received oral glucocorticosteroid (more than 10 mg)
- Immunosuppressive drug
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 |
|---|---|---|
| prednisolone 0.5 mg/kg/day for three monthsAlso: prednisoloneperiod of treatment | Drug | 1 |
| prednisolone 0.5 mg/kg/day for six monthsAlso: prednisoloneperiod of therapy | Drug | 2 |
Primary outcome
Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Time frame: Three years
1 secondary outcome
Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Time frame: Three years
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 19 Sep 2014.
- Derived from this study: PubMed 25614171Oyama Y, Fujisawa T, Hashimoto D, Enomoto N, Nakamura Y, Inui N, Kuroishi S, Yokomura K, Toyoshima M, Yamada T, Shirai T, Masuda M, Yasuda K, Hayakawa H, Chida K, Suda T. Efficacy of short-term prednisolone treatment in patients with chronic eosinophilic pneumonia. Eur Respir J. 2015 Jun;45(6):1624-31. doi: 10.1183/09031936.00199614. Epub 2015 Jan 22.
Related trials for Eosinophilic Pneumonia
RecruitingObservational study
Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils
Eosinophilic Asthma, EGPA - Eosinophilic Granulomatosis With Polyangiitis
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 prednisolone 0.5 mg/kg/day for three months and prednisolone 0.5 mg/kg/day for six months in people with Eosinophilic Pneumonia and Chronic Disease, 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 2 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 19 Sep 2014. 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 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632554, which also lists 1 linked publication.
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 19 Sep 2014.