--- title: Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD nct_id: NCT00489853 overall_status: COMPLETED phase: PHASE4 sponsor: AstraZeneca study_type: INTERVENTIONAL primary_condition: Chronic Obstructive Pulmonary Disease countries: Germany, Switzerland canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00489853.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00489853" ct_last_update_post_date: 2012-08-30 last_seen_at: "2026-05-12T07:11:16.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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). **NCT ID:** [NCT00489853](https://clinicaltrials.gov/study/NCT00489853) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 137 - **Lead Sponsor:** AstraZeneca - **Conditions:** Chronic Obstructive Pulmonary Disease - **Start Date:** 2007-07 - **Completion Date:** 2008-08 - **CT.gov Last Update:** 2012-08-30 ## 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 - **Minimum age:** 40 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Symbicort then Formoterol then Placebo** (EXPERIMENTAL) — 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** (EXPERIMENTAL) — 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** (PLACEBO_COMPARATOR) — 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 - **budesonide/formoterol Turbuhaler 320/9µg** (DRUG) — Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms - **formoterol Turbuhaler 9µg** (DRUG) — Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily - **Placebo** (OTHER) — Placebo, 1 inhalation twice daily ## Primary Outcomes - **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. ## Secondary Outcomes - **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)_ - **Forced Expiratory Flow (FEV1) Pre-dose** _(time frame: Pre-dose at the start of treatment and pre-dose 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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ - **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)_ ## Locations (9) - Research Site, Berlin, Germany - Research Site, Erfurt, Germany - Research Site, Fulda, Germany - Research Site, Fürth, Germany - Research Site, Geesthacht, Germany - Research Site, Grobhansdorf, Germany - Research Site, Leipzig, Germany - Research Site, Neuruppin, Germany - Research Site, Basel, Canton of Basel-City, Switzerland ## Recent Field Changes (last 30 days) - `locations.research site|fulda||germany` — added _(2026-05-12)_ - `locations.research site|fürth||germany` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.research site|berlin||germany` — added _(2026-05-12)_ - `locations.research site|erfurt||germany` — added _(2026-05-12)_ - `locations.research site|geesthacht||germany` — added _(2026-05-12)_ - `locations.research site|grobhansdorf||germany` — added _(2026-05-12)_ - `locations.research site|leipzig||germany` — added _(2026-05-12)_ - `locations.research site|neuruppin||germany` — added _(2026-05-12)_ - `locations.research site|basel|canton of basel-city|switzerland` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00489853.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00489853* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*