- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524641
Asthma Control-A "Patient Follow up Programme" Maintenance and Reliever Therapy in a Single Inhaler
July 8, 2009 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1254
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hanoi, Vietnam
- Research Site
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Ho Chi Minh City, Vietnam
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Hospital out-patient departments and private clinics in all areas of Vietnam
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dinh Ngoc SY, MD, TB and Lung Disease Hospital, Hanoi
- Study Chair: Tran Van Ngoc, MD, PhD, Cho Ray Hospital
- Study Chair: Nguyen Hong Duc, Pharm Ngoc Thach Hospital
- Study Chair: Do Van Dung, MD, PhD, Ho Chi Minh City Univ of Medicine and Pharmacist
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
August 30, 2007
First Submitted That Met QC Criteria
August 31, 2007
First Posted (Estimate)
September 3, 2007
Study Record Updates
Last Update Posted (Estimate)
July 9, 2009
Last Update Submitted That Met QC Criteria
July 8, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-RVN-SYM-2007/1
- NIS-R84-AST-2007/3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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