Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: tiotropium + olodaterol; Device: Respimat; Drug: tiotropium; Drug: olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431274

2009-010668-40 (EudraCT Number)

1237.5

Details and patient eligibility

About

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Enrollment: 2,624 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 post FEV1< 80% predicted normal and post FEV1/FVC <70%.
3. Male or female patients, 40 years of age or older.
4. Smoking history of more than 10 pack years.

Exclusion criteria

1. Significant disease other than COPD
2. Clinically relevant abnormal lab values.
3. History of asthma.
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. History of myocardial infarction within 1 year of screening visit
7. Unstable or life-threatening cardiac arrhythmia.
8. Hospitalization for heart failure within the past year.
9. Known active tuberculosis.
10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. History of life-threatening pulmonary obstruction.
12. History of cystic fibrosis.
13. Clinically evident bronchiectasis.
14. History of significant alcohol or drug abuse.
15. Thoracotomy with pulmonary resection
16. Oral ß-adrenergics.
17. Oral corticosteroid medication at unstable doses
18. Regular use of daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
22. Pregnant or nursing women.
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who are unable to comply with pulmonary medication restrictions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,624 participants in 5 patient groups

tiotropium+olodaterol low dose FDC

Experimental group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Device: Respimat

Drug: tiotropium + olodaterol

Drug: tiotropium + olodaterol

tiotropium+olodaterol high dose FDC

Experimental group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Device: Respimat

Drug: tiotropium + olodaterol

Drug: tiotropium + olodaterol

olodaterol

Active Comparator group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Device: Respimat

Drug: olodaterol

tiotropium low dose

Active Comparator group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Device: Respimat

Drug: tiotropium

Drug: tiotropium

tiotropium high dose

Active Comparator group

Description:

Once daily 2 puffs solution for inhalation Respimat

Treatment:

Device: Respimat

Drug: tiotropium

Drug: tiotropium