NCT00837629

Brief Summary

This non-interventional study is to analyse the therapeutic effectiveness in patients with severe COPD following a generally accepted 12-week treatment period with Symbicort Turbuhaler, which could anyhow be shortened or extended at physician's discretion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Shorter than P25 for all trials

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

February 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

7 months

First QC Date

February 4, 2009

Last Update Submit

January 21, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary diseaseCOPDSymbicort Turbuhaler

Outcome Measures

Primary Outcomes (1)

  • Reduction in overall Clinical COPD Questionnaire (CCQ) score

    12 weeks

Secondary Outcomes (3)

  • Patient satisfaction

    12 weeks

  • Physicians' global clinical impression of the treatment

    12 weeks

  • Evaluation of smoking habits

    12 weeks

Eligibility Criteria

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

patients (outpatient or hospitalised) in whom Symbicort Turbuhaler is indicated according to the current Summary of product characteristics (SPC)

You may qualify if:

  • non pregnant female
  • COPD with persistent symptoms in spite of regular bronchodilator therapy
  • Naive or fixed combination treated patients including patients already on Symbicort Turbuhaler

You may not qualify if:

  • Hypersensitivity to budesonide, formoterol or inhaled lactose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matjaz Flezar, MD

    Golnik Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

February 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 24, 2011

Record last verified: 2011-01