Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00489853
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 19, 2007
First Posted Date  ICMJE June 21, 2007
Results First Submitted Date  ICMJE August 6, 2009
Results First Posted Date  ICMJE August 30, 2012
Last Update Posted Date August 30, 2012
Study Start Date  ICMJE July 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2007)
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 ]
Change History Complete list of historical versions of study NCT00489853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2007)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
Official Title  ICMJE 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).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Worth H, Förster K, Eriksson G, Nihlén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2008)
137
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2007)
100
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00489853
Other Study ID Numbers  ICMJE D5892C00014
Eudract No: 2006-006519-60
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tomas Andersson, MD AstraZeneca
Principal Investigator: Heinrich Worth, MD Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
PRS Account AstraZeneca
Verification Date July 2012

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