NCT00800241

Brief Summary

The purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,020

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

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 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

First QC Date

December 1, 2008

Last Update Submit

December 2, 2010

Conditions

Keywords

AsthmaSymbicort SMARTThai patient eligibilityPersistent asthma

Outcome Measures

Primary Outcomes (1)

  • Number of budesonide/formoterol use per patient

    On the survey date

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged 12 years or older who established persistent asthma and currently treated with Symbicort SMART for 3 months or longer.

You may qualify if:

  • Established persistent asthma
  • Currently treated with Symbicort SMART for 3 months or longer

You may not qualify if:

  • currently participating or have participated in a study with an investigational compound within the last 30 days
  • current diagnosis of chronic obstructive pulmonary disease (COPD)
  • smoked more than 10 pack-year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Buriram, Thailand

Location

Research Site

Chanthaburi, Thailand

Location

Research Site

Chiang Mai, Thailand

Location

Research Site

Mahasarakham, Thailand

Location

Research Site

Nakhon Phanom, Thailand

Location

Research Site

Nakhon Srithammarat, Thailand

Location

Research Site

Nakhonpathom, Thailand

Location

Research Site

Phatthalung, Thailand

Location

Research Site

Phitsanulok, Thailand

Location

Research Site

Rayong, Thailand

Location

Research Site

Roi Et, Thailand

Location

Research Site

Samutsakhon, Thailand

Location

Research Site

Surat Thani, Thailand

Location

Research Site

Trang, Thailand

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bandit Thinkhamrop, PhD.

    Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University

    PRINCIPAL INVESTIGATOR
  • Watchara Boonsawat, MD, PhD

    Department of Medicine, Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 1, 2008

First Posted

December 2, 2008

Study Start

May 1, 2009

Study Completion

November 1, 2009

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations