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NCT00784953 Clinical Trial

Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

Asthma Clinical Trial

Official title:
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00784953
Other study ID # NIS-RTW-SYM-2008/1
Secondary ID
Status Completed
Phase N/A
First received November 3, 2008
Last updated November 9, 2015
Start date October 2008
Est. completion date May 2011

Study information
Verified date November 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

A non-interventional study to explore actual asthma control status in real-life environment and to observe the efficacy after stepped-up to Symbicort SMART or various identical regimens.

The study will be implemented by screening asthmatic patients from respiratory clinics to identify those not optimally controlled and required stepping up the controllers to initiate, or to titrate dose of, ICS/LABA including Symbicort.

Recruitment information / eligibility
Status Completed
Enrollment 842
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Asthma patient who was partly controlled or uncontrolled by previous controllers of ICS only, or low dose ICS plus either LABA, leukotriene modifier or theophylline; or ICS- naïve with severe and persist symptom based on physician's judgment

- According to GINA guideline, who need to step up the controller medications, and ICS/LABA to be prescribed based on physician's discretion

Exclusion Criteria:

- Patients aged not within limitation refer to label information of various product prescribed

- Patients who have taken oral corticosteroids within 4 weeks prior to enrollment

- Patients with contraindications to prescribed medication

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Research Site Changhua
Taiwan Research Site Kaohsiung
Taiwan Research Site Keelung
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Taipei

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in ACQ score from baseline to the mean of all available data from the follow up visits wk 4±1; wk 12~16 No
Secondary Change in the individual asthma control status & pulmonary function from enrollment wk 4±1; wk 12~16 No
Secondary Dose/usage of ICS/LABA and relievers & Patient compliance wk 4±1; wk 12~16 No
Secondary Medical resource utilization wk 4±1; wk 12~16; 6 month; 12 month No
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