Phase 4 N=111 Randomized Quadruple-blind Treatment

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

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT00489853 ↗

Enrolled (actual)

111

Serious AEs

1.3%

Results posted

Aug 2012

Primary outcome: Primary: Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose — 529; 441; 406 Seconds

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: budesonide/formoterol Turbuhaler 320/9µg (Drug); formoterol Turbuhaler 9µg (Drug); Placebo (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose	529; 441; 406	—
SECONDARY Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose	463; 408; 388	—
SECONDARY Forced Expiratory Flow (FEV1) Pre-dose	0.0830; 0.0630; -0.046	—
SECONDARY Forced Vital Capacity (FVC) Pre-dose	0.060; 0.067; -0.094	—
SECONDARY Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)	0.105; 0.089; -0.083	—
SECONDARY Peak Expiratory Flow (PEF) Before Morning Dose	1.30; 5.60; -10.00	—
SECONDARY Sleep Score	-1.70; -0.03; 0.11	—
SECONDARY Breathlessness Score	-0.12; -0.40; 0.15	—
SECONDARY Chest Tightness Score	-0.08; -0.02; 0.17	—
SECONDARY Cough Score	-0.11; -0.05; 0.10	—
SECONDARY Number of Inhalations of Reliever Medication	-0.42; -0.36; 0.51	—
SECONDARY Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose	3.3; 3.4; 3.9	—
SECONDARY Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose	11.5; 11.6; 11.4	—
SECONDARY Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose	3.6; 3.4; 3.9	—
SECONDARY Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose	11.5; 11.5; 11.8	—
SECONDARY Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose	2.06; 2.10; 1.97	—
SECONDARY Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose	2.12; 2.12; 1.85	—
SECONDARY Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)	2.75; 2.73; 2.37	—
SECONDARY Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	2.19; 2.18; 1.91	—
SECONDARY Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	5.59; 5.66; 5.79	—
SECONDARY Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	4.83; 4.94; 5.13	—
SECONDARY Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)	7.58; 7.62; 7.45	—
SECONDARY Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)	2.90; 2.98; 4.22	—
SECONDARY Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)	2.69; 2.64; 2.42	—
SECONDARY Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)	2.14; 2.08; 1.92	—
SECONDARY Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)	5.47; 5.49; 5.82	—
SECONDARY Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)	4.74; 4.79; 5.19	—
SECONDARY Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)	7.41; 7.37; 7.63	—
SECONDARY Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET	3.06; 3.20; 4.12	—
SECONDARY SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score	51.7; 51.6; 54.5	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00489853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.