AsthmaPreludeNCT01370577
The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly
An observational study of Asthma, run by AstraZeneca at 5 sites in South Korea.
Trial summary
The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Asthma
- How many people
- 297 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jul 2011to Nov 2012
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged over 60 years, articulate in Korean, and diagnosed with asthma at least 1 year in duration
Who may be able to join
- Patients aged 60 years or more, articulate in Korean
- Patients diagnosed with asthma, at least 1 year in duration.
Who cannot join
- Patients being followed-up for asthma treatment less than 1 year before baseline
- Patients taking immune therapy
- Patients previously enrolled/randomized in the present clinical trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Research Site
Anyang-si, Gyeonggi-do
Research Site
Busan, Gyeonsangnam-do
Research Site
Changwon, Gyeonsangnam-do
Research Site
Suwon, Gyeonggi-do
Research Site
Wŏnju, Gangwon-do
About this study
The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly
- Conditions
- Asthma
- Keywords
- Predictors for asthma control, Asthma Exacerbation rate, Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence
- Medical subject headings
- Asthma
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 |
|---|---|---|
| 1 | Total 300 subjects who was diagnosed with asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics related to asthma control in the elderly
Measured: 6 months
Asthma exacerbation rate of the elderly during guideline-based stepwise treatments
Measured: 6 months
Secondary outcomes (3)
1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea
Measured: 6 months
2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma
Measured: 6 months
Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence in elderly asthma for the last 1 year before study enrollment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2012
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.
- More trials run by AstraZenecaThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hye Won Koo, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370577
- Sponsor's protocol ID
- NIS-RKR-XXX-2011/1
- Acronym
- Prelude
- Status last verified
- Jan 2013
- First submitted
- 1 Jun 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictors for Asthma Control by Stepwise Treatment During 6 Months in Korean Elderly
- ClinicalTrials.gov ID
- NCT01370577
- Acronym / sponsor ID
- Prelude / NIS-RKR-XXX-2011/1
- Conditions
- Asthma
- Keywords
- Predictors for asthma control, Asthma Exacerbation rate, Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jun 2011 (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.
The Predictors for asthma control by stepwise treatment during 6 months in Korean elderly
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Total 300 subjects who was diagnosed with asthma |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged over 60 years, articulate in Korean, and diagnosed with asthma at least 1 year in duration
Key inclusion criteria (2 listed)
- Patients aged 60 years or more, articulate in Korean
- Patients diagnosed with asthma, at least 1 year in duration.
Key exclusion criteria (3 listed)
- Patients being followed-up for asthma treatment less than 1 year before baseline
- Patients taking immune therapy
- Patients previously enrolled/randomized in the present clinical trial
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
Baseline characteristics related to asthma control in the elderly
Time frame: 6 months
Asthma exacerbation rate of the elderly during guideline-based stepwise treatments
Time frame: 6 months
3 secondary outcomes
1. Proportion of controlled, partially controlled, and controlled patients among the elderly patients with asthma in Korea
Time frame: 6 months
2. Baseline characteristics related to asthma specific QOL in the elderly patients with asthma
Time frame: 6 months
Mean frequency of PFT, sputum assessments, refill adherence(%), prescription persistence in elderly asthma for the last 1 year before study enrollment
Time frame: 6 months
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 14 Jan 2013.
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Asthma
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.
Hye Won Koo study director
AstraZeneca Korea
5 sites 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 AstraZeneca at 5 sites in South Korea.
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 2 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 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Baseline characteristics related to asthma control in the elderly (time frame: 6 months). The study lists 2 primary outcomes in all. 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 14 Jan 2013.