NCT00573222

Brief Summary

This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

Geographic Reach
1 country

13 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

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

December 13, 2007

Last Update Submit

November 30, 2010

Conditions

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • To evaluate & describe asthma control in adult patients w/moderate to severe asthma treated w/Symbicort SMART following the frequency, type & severity of symptoms through the Asthma Control Questionnaire.

Secondary Outcomes (1)

  • to evaluate the safety of Symbicort SMART treatment through the number and type of reported adverse events 2. assessment of patient's satisfaction with the treatment 3.assessment of physician's satisfaction with the treatment

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pulmonology clinics

You may qualify if:

  • Patients with moderate and severe asthma on Symbicort SMART treatment

You may not qualify if:

  • Under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Čakovec, Croatia

Location

Research Site

Dubrovnik, Croatia

Location

Research Site

Osijek, Croatia

Location

Research Site

Požega, Croatia

Location

Research Site

Pula, Croatia

Location

Research Site

Rijeka, Croatia

Location

Research Site

Senj, Croatia

Location

Research Site

Slavonskibrod, Croatia

Location

Research Site

Šibenik, Croatia

Location

Research Site

Vinkovci, Croatia

Location

Research Site

Vukovar, Croatia

Location

Croatia

Zadar, Croatia

Location

Research Site

Zagreb, Croatia

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Anan Marija Gjurovic

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations