Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Seretide

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• asthma not well control

Exclusion Criteria:

• COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Symbicort; We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy	Drug: Seretide; Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety; Other Names: Symbicort compared with Seretide
Experimental: Seretide; In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year	Drug: Seretide; Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety; Other Names: Symbicort compared with Seretide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of asthma total and well control	F/U clinical asthma control status and percentage of Acute exacerbation	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
percentage of asthma acute exacerbation	one year

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 23, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: asthma; SMART; fixed dose
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Sympathomimetics; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: 97083