Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD (CODEX)
July 27, 2012 updated by: AstraZeneca
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).
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- Research Site
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Erfurt, Germany
- Research Site
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Fulda, Germany
- Research Site
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Furth, Germany
- Research Site
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Geesthacht, Germany
- Research Site
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Grobhansdorf, Germany
- Research Site
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Leipzig, Germany
- Research Site
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Neuruppin, Germany
- Research Site
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Basel Stadt
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Basel, Basel Stadt, Switzerland
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- >=40 years of age
- diagnosed COPD with symptoms >= 2 years
- pre-bronchodilatory FEV1 <=50% of PN
Exclusion Criteria:
- Current respiratory tract disorder other than COPD
- history of asthma or rhinitis
- significant or unstable cardiovascular disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Symbicort then Formoterol then Placebo
Symbicort (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
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Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
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Experimental: Formoterol then Symbicort then Placebo
Formoterol 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
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Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
|
|
Placebo Comparator: Placebo then Formoterol then Symbicort
Placebo, 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
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Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
Time Frame: Single measurement taken1 hour post-dose at the end of each 1-week treatment period
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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.
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Single measurement taken1 hour post-dose at the end of each 1-week treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
Time Frame: Single measurement taken 6 hours post-dose at the end of each 1-week treatment period
|
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 taken 6 hours post-dose at the end of each 1-week treatment period
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Forced Expiratory Flow (FEV1) Pre-dose
Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
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The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
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Pre-dose at the start of treatment and pre-dose after one week of treatment
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Forced Vital Capacity (FVC) Pre-dose
Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
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The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
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Pre-dose at the start of treatment and pre-dose after one week of treatment
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Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
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The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
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Pre-dose at the start of treatment and pre-dose after one week of treatment
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Peak Expiratory Flow (PEF) Before Morning Dose
Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.
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Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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Sleep Score
Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).
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Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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Breathlessness Score
Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing).
All patients with data from both periods are included.
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Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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Chest Tightness Score
Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).
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Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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Cough Score
Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).
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Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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Number of Inhalations of Reliever Medication
Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.
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Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose
Time Frame: Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness.
Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).
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Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose
Time Frame: Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
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Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose
Time Frame: Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
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Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Time Frame: Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
All patients with data are included.
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Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose
Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
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Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
|
Treatment means from individual participant data.
|
Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
|
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Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
|
Treatment means from individual participant data.
|
Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
|
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Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
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Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET
Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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Treatment means from individual participant data.
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Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score
Time Frame: Single measurement taken at the end of each 1-week treatment period
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Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state).
Includes all patients with data.
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Single measurement taken at the end of each 1-week treatment period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tomas Andersson, MD, AstraZeneca
- Principal Investigator: Heinrich Worth, MD, Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
June 19, 2007
First Submitted That Met QC Criteria
June 19, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Estimate)
August 30, 2012
Last Update Submitted That Met QC Criteria
July 27, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
Other Study ID Numbers
- D5892C00014
- Eudract No: 2006-006519-60
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