NCT00576316

Brief Summary

The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 29, 2009

Completed
Last Updated

December 16, 2010

Status Verified

November 1, 2010

First QC Date

December 17, 2007

Results QC Date

November 19, 2009

Last Update Submit

November 30, 2010

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART

    Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction

    6 months after each patient was initially treated with Symbicort SMART

Secondary Outcomes (1)

  • Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART

    6 months after each patient was initially treated with Symbicort SMART

Interventions

Symbicort Turbuhaler 160/4.5DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months.
  • Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines.

You may not qualify if:

  • Patients already on Symbicort SMART treatment.
  • Patients who has respiratory tract infection 30 days before study enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Akhmal Yusof, MD

    AstraZeneca

    STUDY DIRECTOR

  • Aziah Ahmad Mahayiddin, MD

    Kuala Lumpur Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 19, 2007

Study Start

January 1, 2008

Study Completion

November 1, 2008

Last Updated

December 16, 2010

Results First Posted

December 29, 2009

Record last verified: 2010-11

Locations

MY(1)