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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • Berlin, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Fulda, Germany
        • Research Site
      • Furth, Germany
        • Research Site
      • Geesthacht, Germany
        • Research Site
      • Grobhansdorf, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Neuruppin, Germany
        • Research Site
  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: budesonide/formoterol Turbuhaler 320/9µg
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Drug: formoterol Turbuhaler 9µg
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Other: Placebo
Placebo, 1 inhalation twice daily
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
Drug: budesonide/formoterol Turbuhaler 320/9µg
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Drug: formoterol Turbuhaler 9µg
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Other: Placebo
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
Drug: budesonide/formoterol Turbuhaler 320/9µg
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
Drug: formoterol Turbuhaler 9µg
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Other: Placebo
Placebo, 1 inhalation twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Forced Expiratory Flow (FEV1) Pre-dose
Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
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.
Pre-dose at the start of treatment and pre-dose after one week of treatment
Forced Vital Capacity (FVC) Pre-dose
Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
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.
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)
Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
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.
Pre-dose at the start of treatment and pre-dose after one week of treatment
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
The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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
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).
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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
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.
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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
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).
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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
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).
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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
The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.
Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
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
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).
Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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
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.
Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
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
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
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
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
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
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
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
Treatment means from individual participant data.
Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
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
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
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
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
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
Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.
Single measurement taken at the end of each 1-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5892C00014
  • Eudract No: 2006-006519-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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