Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia - Full Text View

Purpose

The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.

Condition	Intervention	Phase
Asthma	Drug: Symbicort (Budesonide/Formoterol)	Phase 4

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Secondary Outcome Measures:

Change in ACQ(5) Score From Baseline at Country Level (China) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Change in Overall ACQ(5) Score From Baseline at Country Level (India) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)
Change in AQLQ (S) Domain (Symptom) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)
Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)
Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.
Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day

Enrollment:	862
Study Start Date:	July 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Symbicort Turbuhaler 160/4.5 µg delivered dose	Drug: Symbicort (Budesonide/Formoterol) Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms Other Name: Symbicort

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of signed informed consent
Asthma diagnosis at least 6 months before visit 1 of study
Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study

Exclusion Criteria:

Known or suspected allergy to active ingredients of study medication or excipients
Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
Smoking, current or previous with a smoking history of ≥ 10 pack years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939341

Show 35 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Guy Yeoman, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00939341 History of Changes
Other Study ID Numbers:	D5890L00035
Study First Received:	July 13, 2009
Results First Received:	August 11, 2011
Last Updated:	January 12, 2012
Health Authority:	China: Ethics Committee India: Ministry of Health Indonesia: Departement Kesehatan (Department of Health) Taiwan: Institutional Review Board Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Symbicort SMART

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia (SMARTASIA)