Clinical trial NCT00784953: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma
Official title: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Symbicort SMART
budesonide
formoterol
ICS/LABA
Asthma Control Questionnaire
Not optimally controlled asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 842
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical center

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.


Eligibility 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

Primary outcomes:
measure: Change in ACQ score from baseline to the mean of all available data from the follow up visits
timeFrame: wk 4±1; wk 12~16
Secondary outcomes:
measure: Change in the individual asthma control status & pulmonary function from enrollment
timeFrame: wk 4±1; wk 12~16
measure: Dose/usage of ICS/LABA and relievers & Patient compliance
timeFrame: wk 4±1; wk 12~16
measure: Medical resource utilization
timeFrame: wk 4±1; wk 12~16; 6 month; 12 month
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Keelung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca Taiwan
name: Robin Meng, MD, PhD
role: STUDY_DIRECTOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Jia-Horng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng SL, Ho ML, Lai YF, Wang HC, Hsu JY, Liu SF, Huang MS, Lee CH, Lin CH, Hang LW, Liu YC, Yang KY, Wang JH. Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus As-Needed, Short-Acting beta2 Agonist: Real-World Effectiveness in pAtients without Optimally Controlled asThma (REACT) Study. Drug Des Devel Ther. 2020 Dec 8;14:5441-5450. doi: 10.2147/DDDT.S266177. eCollection 2020.