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

Sponsored by Boehringer Ingelheim Pharmaceuticals

Purpose

The primary 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).

 

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: tiotropium+olodaterol FDC Drug: olodaterol Drug: tiotropium	Phase III

Arms	Assigned Interventions
tiotropium+olodaterol low dose FDC: Experimental Once daily 2 puffs solution for inhalation Respimat Intervention: Drug: tiotropium+olodaterol FDC	Drug: tiotropium+olodaterol FDC low dose or high dose
tiotropium+olodaterol high dose FDC: Experimental Once daily 2 puffs solution for inhalation Respimat Intervention: Drug: tiotropium+olodaterol FDC	Drug: tiotropium+olodaterol FDC low dose or high dose
olodaterol: Active Comparator Once daily 2 puffs solution for inhalation Respimat Intervention: Drug: olodaterol	Drug: olodaterol one dose only
tiotropium low dose: Active Comparator Once daily 2 puffs solution for inhalation Respimat	Drug: tiotropium low dose or high dose
Intervention: Drug: tiotropium
tiotropium high dose: Active Comparator Once daily 2 puffs solution for inhalation Respimat Intervention: Drug: tiotropium	Drug: tiotropium low dose or high dose

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Health Volunteers	No

Criteria

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, 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

Contacts and Locations

Physicians:
James Tita, DO
Vijay Mahajan, MD
Srinivas Katragadda, MD

Coordinators:
Lisa Graham, RN, CCRC
Kristen Miller, BSN, CCRC

Please contact us at 419-251-4919 for more information about this study.