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CompletedNCT00784953Updated Nov 10, 2015

Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

An observational study in Asthma, sponsored by AstraZeneca. Completed at 6 sites in Taiwan. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
842
Sex
All
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Study 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.

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Conditions studied

  • Asthma

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Keywords

  • Symbicort SMART
  • budesonide
  • formoterol
  • ICS/LABA
  • Asthma Control Questionnaire
  • Not optimally controlled asthma
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 842 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
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Study design

Time perspective
Prospective
Enrollment
842 participants (actual)

Groups and cohorts

  • 1

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

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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

6 sites
  • Research Site
    Changhua, Taiwan
  • Research Site
    Kaohsiung, Taiwan
  • Research Site
    Keelung, Taiwan
  • Research Site
    Taichung, Taiwan
  • Research Site
    Tainan, Taiwan
  • Research Site
    Taipei, Taiwan
08

References and documents

Publications

  • 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. Erratum In: Drug Des Devel Ther. 2021 Feb 12;15:515-516. doi: 10.2147/DDDT.S300704. PubMed 33324041 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00784953
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Nov 4, 2008
Start date
Oct 2008
Primary completion
May 2011
Completion
May 2011
Last update
Nov 10, 2015

Study contacts

Robin Meng, MD, PhD
study director · AstraZeneca Taiwan
Jia-Horng Wang, MD
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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