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. Identifier: NCT00784953
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : November 10, 2015
Information provided by (Responsible Party):

Brief 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.

Condition or disease

Study Type : Observational
Actual Enrollment : 842 participants
Time Perspective: Prospective
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 : October 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Asthma patients who were partly controlled or uncontrolled, need to step up, or adjust dose of the controller medications to ICS/LABA

Primary Outcome Measures :
  1. Change in ACQ score from baseline to the mean of all available data from the follow up visits [ Time Frame: wk 4±1; wk 12~16 ]

Secondary Outcome Measures :
  1. Change in the individual asthma control status & pulmonary function from enrollment [ Time Frame: wk 4±1; wk 12~16 ]
  2. Dose/usage of ICS/LABA and relievers & Patient compliance [ Time Frame: wk 4±1; wk 12~16 ]
  3. Medical resource utilization [ Time Frame: wk 4±1; wk 12~16; 6 month; 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Medical center

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784953

Research Site
Changhua, Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Keelung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
Study Director: Robin Meng, MD, PhD AstraZeneca Taiwan
Principal Investigator: Jia-Horng Wang, MD Taipei Veterans General Hospital, Taiwan

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00784953     History of Changes
Other Study ID Numbers: NIS-RTW-SYM-2008/1
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by AstraZeneca:
Symbicort SMART
Asthma Control Questionnaire
Not optimally controlled asthma

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
Anti-Asthmatic Agents
Respiratory System Agents