Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

NCT00784953 | Completed

• 1 other identifier: NIS-RTW-SYM-2008/1
• Study Type: observational
• Target: 842
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in ACQ score from baseline to the mean of all available data from the follow up visits

  wk 4±1; wk 12~16

Secondary Outcomes (3)

• Change in the individual asthma control status & pulmonary function from enrollment

  wk 4±1; wk 12~16

• Dose/usage of ICS/LABA and relievers & Patient compliance

  wk 4±1; wk 12~16

• Medical resource utilization

  wk 4±1; wk 12~16; 6 month; 12 month

Study Arms (1)

1

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Medical center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Changhua, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

Keelung, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33324041 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robin Meng, MD, PhD

  AstraZeneca Taiwan

  STUDY DIRECTOR

• Jia-Horng Wang, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 4, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

TW (6)