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OpenTrials
Completed

NCT Number: NCT00784953

Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Changhua, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2008
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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