We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01647646
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
Shih-Lung Cheng, Far Eastern Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Seretide Phase 4

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
Study Start Date : March 2009
Primary Completion Date : February 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 Name: 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 Name: Symbicort compared with Seretide

Primary Outcome Measures :
  1. the percentage of asthma total and well control [ Time Frame: one year ]
    F/U clinical asthma control status and percentage of Acute exacerbation

Secondary Outcome Measures :
  1. percentage of asthma acute exacerbation [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • asthma not well control

Exclusion Criteria:

  • COPD

Responsible Party: Shih-Lung Cheng, Chief, Division of Pulmonary Medicine, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01647646     History of Changes
Other Study ID Numbers: 97083
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Shih-Lung Cheng, Far Eastern Memorial Hospital:
fixed dose

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists