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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00784953
Enrollment
842
Registered
2008-11-04
Start date
2008-10-31
Completion date
2011-05-31
Last updated
2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Symbicort SMART, budesonide, formoterol, ICS/LABA, Asthma Control Questionnaire, Not optimally controlled asthma

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.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in ACQ score from baseline to the mean of all available data from the follow up visitswk 4±1; wk 12~16

Secondary

MeasureTime frame
Change in the individual asthma control status & pulmonary function from enrollmentwk 4±1; wk 12~16
Dose/usage of ICS/LABA and relievers & Patient compliancewk 4±1; wk 12~16
Medical resource utilizationwk 4±1; wk 12~16; 6 month; 12 month

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026