Real Life Effectiveness in Patients With Not Optimally Controlled Asthma - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00784953

Purpose

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
Asthma

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Symbicort

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the individual asthma control status & pulmonary function from enrollment [ Time Frame: wk 4±1; wk 12~16 ] [ Designated as safety issue: No ]
Dose/usage of ICS/LABA and relievers & Patient compliance [ Time Frame: wk 4±1; wk 12~16 ] [ Designated as safety issue: No ]
Medical resource utilization [ Time Frame: wk 4±1; wk 12~16; 6 month; 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	1100
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Medical center

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784953

Locations

Taiwan
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

AstraZeneca

Investigators

Study Director:	Robin Meng, MD, PhD	AstraZeneca Taiwan
Principal Investigator:	Jia-Horng Wang, MD	Taipei Veterans General Hospital,Taiwan

More Information

No publications provided

Responsible Party:	Robin Meng, MD, PhD; Medical Director, AstraZeneca Taiwan
ClinicalTrials.gov Identifier:	NCT00784953 History of Changes
Other Study ID Numbers:	NIS-RTW-SYM-2008/1
Study First Received:	November 3, 2008
Last Updated:	March 24, 2011
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by AstraZeneca:

Symbicort SMART
budesonide
formoterol

ICS/LABA
Asthma Control Questionnaire
Not optimally controlled asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012