Clinical trial NCT00489853: Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 137
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
timeFrame: Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Secondary outcomes:
measure: Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
timeFrame: Single measurement taken 6 hours post-dose at the end of each 1-week treatment period
measure: Forced Expiratory Flow (FEV1) Pre-dose
timeFrame: Pre-dose at the start of treatment and pre-dose after one week of treatment
measure: Forced Vital Capacity (FVC) Pre-dose
timeFrame: Pre-dose at the start of treatment and pre-dose after one week of treatment
measure: Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
timeFrame: Pre-dose at the start of treatment and pre-dose after one week of treatment
measure: Peak Expiratory Flow (PEF) Before Morning Dose
timeFrame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
measure: Sleep Score
timeFrame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
measure: Breathlessness Score
timeFrame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
measure: Chest Tightness Score
timeFrame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
measure: Cough Score
timeFrame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
measure: Number of Inhalations of Reliever Medication
timeFrame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
measure: Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose
timeFrame: Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose
timeFrame: Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose
timeFrame: Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose
timeFrame: Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose
timeFrame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose
timeFrame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
measure: Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
measure: Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
measure: Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
timeFrame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET
timeFrame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
measure: SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score
timeFrame: Single measurement taken at the end of each 1-week treatment period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Furth
country: Germany
facility: Research Site
city: Geesthacht
country: Germany
facility: Research Site
city: Grobhansdorf
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Neuruppin
country: Germany
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
state: Basel Stadt
Study officials:
affiliation: AstraZeneca
name: Tomas Andersson, MD
role: STUDY_DIRECTOR
affiliation: Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
name: Heinrich Worth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worth H, Forster K, Eriksson G, Nihlen 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.