AsthmaNCT00524641
Asthma Control-A "Patient Follow up Programme" Maintenance and Reliever Therapy in a Single Inhaler
An observational study of Asthma, run by AstraZeneca at 2 sites in Vietnam.
Trial summary
To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 1,254 participants
- Where
- 2 sitesVietnam
- Study dates
- Jul 2007to Apr 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital out-patient departments and private clinics in all areas of Vietnam
Who may be able to join
- Asthma patients from both sexes, age 18 or older
- Have already been on Symbicort SMART treatment
- Willing to give written informed consents to participate in the program.
Who cannot join
- Patients who are not willing to give written informed consent
- Patients in emergency care for asthma at ICUs or COPD patients are excluded from the program.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Patient Follow-up Program to Assess Asthma Control in Patients Using Symbicort® as Maintenance and Relief Therapy in a Single Inhaler (Symbicort® SMART: Budesonide/Formoterol 160/4.5 Mcg, 1 or 2 Inhalations x 2 Times Plus Additional Inhalations as Needed)
To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort, NIS
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionApr 2008
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
- Time perspective
- Prospective
- Enrolment
- 1,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dinh Ngoc SY, MD, Study chair, TB and Lung Disease Hospital, HanoiTran Van Ngoc, MD, PhD, Study chair, Cho Ray HospitalNguyen Hong Duc, Study chair, Pharm Ngoc Thach HospitalDo Van Dung, MD, PhD, Study chair, Ho Chi Minh City Univ of Medicine and Pharmacist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524641
- Sponsor's protocol ID
- NIS-RVN-SYM-2007/1
- Other IDs
- NIS-R84-AST-2007/3
- Status last verified
- Jul 2009
- First submitted
- 30 Aug 2007
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Follow-up Program to Assess Asthma Control in Patients Using Symbicort® as Maintenance and Relief Therapy in a Single Inhaler (Symbicort® SMART: Budesonide/Formoterol 160/4.5 Mcg, 1 or 2 Inhalations x 2 Times Plus Additional Inhalations as Needed)
- ClinicalTrials.gov ID
- NCT00524641
- Acronym / sponsor ID
- NIS-RVN-SYM-2007/1
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort, NIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,254 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Sep 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.
To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital out-patient departments and private clinics in all areas of Vietnam
Key inclusion criteria (3 listed)
- Asthma patients from both sexes, age 18 or older
- Have already been on Symbicort SMART treatment
- Willing to give written informed consents to participate in the program.
Key exclusion criteria (2 listed)
- Patients who are not willing to give written informed consent
- Patients in emergency care for asthma at ICUs or COPD patients are excluded from the program.
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.
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 9 Jul 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.
Dinh Ngoc SY, MD study chair
TB and Lung Disease Hospital, Hanoi
Tran Van Ngoc, MD, PhD study chair
Cho Ray Hospital
Nguyen Hong Duc study chair
Pharm Ngoc Thach Hospital
2 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 2 sites in Vietnam.
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 3 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 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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 9 Jul 2009.