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



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:September 2011
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

Use our guide to learn which trials are right for you!

A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]


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 COPD.


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
We found this trial at
35
sites
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bayside, NY
Click here to add this to my saved trials
Charleston, South Carolina
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Couer d'Alene, ID
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Deland, FL
Click here to add this to my saved trials
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greenville, South Carolina
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greer, CA
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
?
mi
from
Killeen, TX
Click here to add this to my saved trials
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Spartanburg, South Carolina
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Union, SC
Click here to add this to my saved trials
?
mi
from
Winter Park, FL
Click here to add this to my saved trials