Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: olodaterol; Drug: fluticasone propionate; Drug: placebo; Drug: salmeterol; Drug: tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01969721

1237.11

2013-000808-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of chronic obstructive pulmonary disease
2. 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%
3. Male or female patients, 40 years of age or older
4. Smoking history of more than 10 pack years
5. Ability to perform technically acceptable pulmonary function tests and maintain records
6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)

Exclusion criteria

1. Significant disease other than COPD
2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
3. Clinically relevant abnormal lab values
4. History of asthma
5. Diagnosis of thyrotoxicosis
6. Diagnosis of paroxysmal tachycardia
7. History of myocardial infarction
8. Unstable or life-threatening cardiac arrhythmia
9. Hospitalization for heart failure within the past year
10. Known active tuberculosis
11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
12. History of life-threatening pulmonary obstruction
13. History of cystic fibrosis
14. Clinically evident bronchiectasis
15. History of significant alcohol or drug abuse
16. History of thoracotomy with pulmonary resection
17. oral or patch ß-adrenergics
18. Oral corticosteroid medication within 6 weeks prior to Visit 1
19. Regular use daytime oxygen therapy for more than one hour per day
20. Pulmonary rehabilitation program in the six weeks prior to the screening visit
21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
23. Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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229 participants in 4 patient groups

T+O FDC dosage 1

Experimental group

Description:

Low dose

Treatment:

Drug: placebo

Drug: placebo

Drug: olodaterol

Drug: placebo

Drug: tiotropium

Drug: placebo

Drug: olodaterol

Drug: tiotropium

T+O FDC dosage 2

Experimental group

Description:

High dose

Treatment:

Drug: placebo

Drug: placebo

Drug: olodaterol

Drug: placebo

Drug: tiotropium

Drug: placebo

Drug: olodaterol

Drug: tiotropium

ICS/LABA FDC Dosage 1

Active Comparator group

Description:

Low dose

Treatment:

Drug: salmeterol

Drug: fluticasone propionate

Drug: placebo

Drug: placebo

Drug: placebo

Drug: salmeterol

Drug: placebo

Drug: fluticasone propionate

ICS/LABA FDC Dosage 2

Active Comparator group

Description:

High dose

Treatment:

Drug: salmeterol

Drug: fluticasone propionate

Drug: placebo

Drug: placebo

Drug: placebo

Drug: salmeterol

Drug: placebo

Drug: fluticasone propionate