NCT00611520

Brief Summary

Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64,730

participants targeted

Target at P75+ 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

September 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

January 29, 2008

Last Update Submit

January 27, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

treatment of COPDrelated to the budesonide/formoterole therapy in patients with COPD.

Outcome Measures

Secondary Outcomes (1)

  • to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population

Study Arms (1)

1

Patients with COPD treated with budesonide/formoterol

Eligibility Criteria

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

patients

You may qualify if:

  • Patients with COPD treated with budesonide/formoterol

You may not qualify if:

  • limitations; possible risks; warnings; contraindications mentioned in the SPC.

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

  • Kai Richter, MD

    Medical Department AstraZeneca Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 11, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2005

Last Updated

January 28, 2011

Record last verified: 2011-01