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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: budesonide/formoterol Turbuhaler 320/9µg; Drug: formoterol Turbuhaler 9µg; Other: Placebo

• Registration Number: NCT00489853
• Lead Sponsor: AstraZeneca

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 available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-21
• Study Start: 2007-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-06
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Results First Posted: 2012-08-30
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• >=40 years of age
• diagnosed COPD with symptoms >= 2 years
• pre-bronchodilatory FEV1 <=50% of PN

Read More

Exclusion Criteria

• Current respiratory tract disorder other than COPD
• history of asthma or rhinitis
• significant or unstable cardiovascular disorder

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Symbicort then Formoterol then Placebo	formoterol Turbuhaler 9µg	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
Formoterol then Symbicort then Placebo	formoterol Turbuhaler 9µg	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
Placebo then Formoterol then Symbicort	formoterol Turbuhaler 9µg	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
Symbicort then Formoterol then Placebo	budesonide/formoterol Turbuhaler 320/9µg	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
Symbicort then Formoterol then Placebo	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
Formoterol then Symbicort then Placebo	budesonide/formoterol Turbuhaler 320/9µg	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
Formoterol then Symbicort then Placebo	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
Placebo then Formoterol then Symbicort	budesonide/formoterol Turbuhaler 320/9µg	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
Placebo then Formoterol then Symbicort	Placebo	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

Primary Outcome Measures

Name	Time	Method
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose	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 Outcome Measures

Name	Time	Method
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose	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	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	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)	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	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	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	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	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	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	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	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	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	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	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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	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.

Trial Locations

Locations (1)

Research Site; 🇨🇭 Basel, Basel Stadt, Switzerland