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NCT01647646 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 NCT01647646
Other study ID # 97083
Secondary ID
Status Completed
Phase Phase 4
First received July 19, 2012
Last updated July 23, 2012
Start date March 2009
Est. completion date March 2012

Study information
Verified date July 2012
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.

Description:

1. All not-well controlled asthma patients would include the study.

2. We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses

3. We will evaluate the efficacy/safety for these not-well controlled patients.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2012
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- asthma not well control

Exclusion Criteria:

- COPD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Seretide
Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary the percentage of asthma total and well control F/U clinical asthma control status and percentage of Acute exacerbation one year Yes
Secondary percentage of asthma acute exacerbation one year Yes
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