Phase 3
Completed N=229
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01969721 ↗
Enrolled (actual)
229
Serious AEs
3.0%
Results posted
Feb 2016
Primary outcomePrimary: FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment — 0.295; 0.317; 0.192; 0.188 Litres — p=<0.0001
Summary
The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment |
0.295; 0.317; 0.192; 0.188 | <0.0001 sig |
| SECONDARY FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment |
0.228; 0.244; 0.162; 0.159 | <0.0001 sig |
| SECONDARY Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment |
0.192; 0.197; 0.150; 0.139 | 0.0002 sig |
| SECONDARY FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment |
0.160; 0.172; 0.132; 0.129 | 0.0007 sig |
| SECONDARY FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment |
0.401; 0.432; 0.291; 0.285 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic obstructive pulmonary disease
- Relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume in 1 second (FEV1)<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)FVC <70%
- Male or female patients, 40 years of age or older
- Smoking history of more than 10 pack years
- Ability to perform technically acceptable pulmonary function tests and maintain records
- Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)
Exclusion criteria
- Significant disease other than COPD
- COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
- Clinically relevant abnormal lab values
- History of asthma
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- History of myocardial infarction
- Unstable or life-threatening cardiac arrhythmia
- Hospitalization for heart failure within the past year
- Known active tuberculosis
- malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction
- History of cystic fibrosis
- Clinically evident bronchiectasis
- History of significant alcohol or drug abuse
- History of thoracotomy with pulmonary resection
- oral or patch ß-adrenergics
- Oral corticosteroid medication within 6 weeks prior to Visit 1
- Regular use daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT01969721). 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. Informational only — not medical advice.