AsthmaNCT00559689
Study of Inhaled Glucocorticosteroid Administration in Asthma Patients
An observational study of Asthma, run by Hamamatsu University at 1 site in Japan.
Trial summary
Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide,hydrofluoroalkane-beclomethasone dipropionate and Budesonide,hydrofluoroalkane-beclomethasone
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2005to Mar 2007
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University Hospital
Who may be able to join
- Receive ICS for one year or more, with no change in dose within the previous 8 weeks
Who cannot join
- Two or more courses of oral corticosteroid in the previous 12 months
- Admission to hospital due to asthma in the previous 6 months
- Admission to the intensive care unit due to asthma at any time in the past
- Current cigarette smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients
Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients.
- Conditions
- Asthma
- Being tested
- Budesonide,hydrofluoroalkane-beclomethasone dipropionate, Budesonide,hydrofluoroalkane-beclomethasone
- Keywords
- asthma patients, well-controlled
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide,hydrofluoroalkane-beclomethasone dipropionateDrug
receive twice-daily administration
Budesonide,hydrofluoroalkane-beclomethasoneDrug
once-daily administration at bedtime
| Study group | Role | What they receive |
|---|---|---|
| 1 | receive once-daily administration of inhaled glucocorticosteroids at bedtime Receives: Drug: Budesonide,hydrofluoroalkane-beclomethasone | |
| 2 | receive twice-daily administration of inhaled glucocorticosteroids Receives: Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
once-daily administration of inhaled glucocorticosteroids can control airway inflammation
Measured: two-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2005
- Study completionMar 2007
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Investigators
- Kingo Chida, MD,PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559689
- Sponsor's protocol ID
- Hamamatsu-17-43
- Other IDs
- H-17-43
- Status last verified
- Mar 2009
- First submitted
- 15 Nov 2007
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients
- ClinicalTrials.gov ID
- NCT00559689
- Acronym / sponsor ID
- Hamamatsu-17-43
- Conditions
- Asthma
- Keywords
- asthma patients, well-controlled
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Nov 2007 (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.
Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Budesonide,hydrofluoroalkane-beclomethasonereceive once-daily administration of inhaled glucocorticosteroids at bedtime |
| 2 | – | Drug: Budesonide,hydrofluoroalkane-beclomethasone dipropionatereceive twice-daily administration of inhaled glucocorticosteroids |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University Hospital
Key inclusion criteria (1 listed)
- Receive ICS for one year or more, with no change in dose within the previous 8 weeks
Key exclusion criteria (4 listed)
- Two or more courses of oral corticosteroid in the previous 12 months
- Admission to hospital due to asthma in the previous 6 months
- Admission to the intensive care unit due to asthma at any time in the past
- Current cigarette smoker.
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 |
|---|---|---|
| Budesonide,hydrofluoroalkane-beclomethasone dipropionatereceive twice-daily administration | Drug | 2 |
| Budesonide,hydrofluoroalkane-beclomethasoneonce-daily administration at bedtime | Drug | 1 |
Primary outcome
once-daily administration of inhaled glucocorticosteroids can control airway inflammation
Time frame: two-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 16 Mar 2009.
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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
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 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 4 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 16 Mar 2009. 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.
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?
once-daily administration of inhaled glucocorticosteroids can control airway inflammation (time frame: two-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 16 Mar 2009.