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

Chronic Obstructive Pulmonary Disease Clinical Trial

— CODEX  

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489853
• Other study ID #: D5892C00014
• Secondary ID: Eudract No: 2006
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2007
• Last updated: July 27, 2012
• Start date: July 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• budesonide/formoterol Turbuhaler 320/9µg
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
• formoterol Turbuhaler 9µg
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

Other:
• Placebo
Placebo, 1 inhalation twice daily

Locations

Country	Name	City	State
Germany	Research Site	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
Switzerland	Research Site	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose	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	No
Secondary	Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose	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	No
Secondary	Forced Expiratory Flow (FEV1) Pre-dose	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	No
Secondary	Forced Vital Capacity (FVC) Pre-dose	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	No
Secondary	Vital Capacity (VC) Pre-dose (Change From Pre-treatment to 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	No
Secondary	Peak Expiratory Flow (PEF) Before Morning Dose	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	No
Secondary	Sleep Score	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	No
Secondary	Breathlessness Score	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	No
Secondary	Chest Tightness Score	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	No
Secondary	Cough Score	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	No
Secondary	Number of Inhalations of Reliever Medication	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	No
Secondary	Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose	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	No
Secondary	Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose	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	No
Secondary	Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose	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	No
Secondary	Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose	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	No
Secondary	Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose	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	No
Secondary	Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose	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	No
Secondary	Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)	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	No
Secondary	Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)	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	No
Secondary	Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)	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	No
Secondary	Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)	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	No
Secondary	Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET	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	No
Secondary	SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score	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	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US