Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
CODEX
A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
2 other identifiers
interventional
137
2 countries
9
Brief Summary
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 chronic-obstructive-pulmonary-disease
Started Jul 2007
Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease
9 active sites
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
June 19, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
August 30, 2012
CompletedAugust 30, 2012
July 1, 2012
1.1 years
June 19, 2007
August 6, 2009
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Secondary Outcomes (29)
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
Single measurement taken 6 hours post-dose at the end of each 1-week treatment period
Forced Expiratory Flow (FEV1) Pre-dose
Pre-dose at the start of treatment and pre-dose after one week of treatment
Forced Vital Capacity (FVC) Pre-dose
Pre-dose at the start of treatment and pre-dose after one week of treatment
Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
Pre-dose at the start of treatment and pre-dose after one week of treatment
Peak Expiratory Flow (PEF) Before Morning Dose
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
- +24 more secondary outcomes
Study Arms (3)
Symbicort then Formoterol then Placebo
EXPERIMENTALSymbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
Formoterol then Symbicort then Placebo
EXPERIMENTALFormoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
Placebo then Formoterol then Symbicort
PLACEBO COMPARATORPlacebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Interventions
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Eligibility Criteria
You may qualify if:
- \>=40 years of age
- diagnosed COPD with symptoms \>= 2 years
- pre-bronchodilatory FEV1 \<=50% of PN
You may not qualify if:
- Current respiratory tract disorder other than COPD
- history of asthma or rhinitis
- significant or unstable cardiovascular disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (9)
Research Site
Berlin, Germany
Research Site
Erfurt, Germany
Research Site
Fulda, Germany
Research Site
Fürth, Germany
Research Site
Geesthacht, Germany
Research Site
Grobhansdorf, Germany
Research Site
Leipzig, Germany
Research Site
Neuruppin, Germany
Research Site
Basel, Canton of Basel-City, Switzerland
Related Publications (1)
Worth H, Forster K, Eriksson G, Nihlen U, Peterson S, Magnussen H. Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD. Respir Med. 2010 Oct;104(10):1450-9. doi: 10.1016/j.rmed.2010.07.006. Epub 2010 Aug 7.
PMID: 20692140DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tomas Andersson, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Heinrich Worth, MD
Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2007
First Posted
June 21, 2007
Study Start
July 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 30, 2012
Results First Posted
August 30, 2012
Record last verified: 2012-07