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Completed

NCT Number: NCT00489853

Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol Turbuhaler 320/9µg

Drug

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms

formoterol Turbuhaler 9µg

Drug

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

Placebo

Other

Placebo, 1 inhalation twice daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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).

  9. 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).

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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).

Acronym: CODEX

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 21, 2007
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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