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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00489853
First received: June 19, 2007
Last updated: July 27, 2012
Last verified: July 2012

June 19, 2007
July 27, 2012
July 2007
August 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
The primary outcome variable is Exercise Endurance Time (EET) measured at 75% of peak work capacity with cycle ergometry. [ Time Frame: 1 hour post dose ]
Complete list of historical versions of study NCT00489853 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Forced Expiratory Flow (FEV1) Pre-dose [ Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment ] [ Designated as safety issue: No ]
    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.
  • Forced Vital Capacity (FVC) Pre-dose [ Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    The change in average value for the run-in or wash-out period to the average value of the subsequent 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
  • 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 ] [ Designated as safety issue: No ]
    The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Treatment means from individual participant data.
  • 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 ] [ Designated as safety issue: No ]
    Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.
  • Exercise Endurance Test [ Time Frame: 6 hours post dose ]
  • Dyspnea Score [ Time Frame: each clinical visit ]
  • Lung Function [ Time Frame: each clinical visit ]
  • Symptoms and Health Status questionnaire [ Time Frame: each clinical visit ]
  • Reliever Medication Use [ Time Frame: Daily ]
  • Peak Expiratory Flow [ Time Frame: Daily ]
Not Provided
Not Provided
 
Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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: 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
    Interventions:
    • Drug: budesonide/formoterol Turbuhaler 320/9µg
    • Drug: formoterol Turbuhaler 9µg
    • Other: Placebo
  • 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
    Interventions:
    • Drug: budesonide/formoterol Turbuhaler 320/9µg
    • Drug: formoterol Turbuhaler 9µg
    • Other: Placebo
  • 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
    Interventions:
    • Drug: budesonide/formoterol Turbuhaler 320/9µg
    • Drug: formoterol Turbuhaler 9µg
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00489853
D5892C00014, Eudract No: 2006-006519-60
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tomas Andersson, MD AstraZeneca
Principal Investigator: Heinrich Worth, MD Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
AstraZeneca
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP