Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

NCT ID: NCT01696058

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-10-31

Brief Summary

The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Olodaterol andTiotropium

2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered

Group Type: EXPERIMENTAL

Tiotropium

Intervention Type: DRUG

marketed product

Olodaterol

Intervention Type: DRUG

one dose

Placebo and Tiotropium

2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered

Group Type: OTHER

Tiotropium

Intervention Type: DRUG

marketed product

Placebo matching Olodaterol

Intervention Type: DRUG

one dose

Interventions

Tiotropium

marketed product

Intervention Type: DRUG

Placebo matching Olodaterol

one dose

Intervention Type: DRUG

Tiotropium

marketed product

Intervention Type: DRUG

Olodaterol

one dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All patients must sign an informed consent consistent with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.

2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have a relatively stable airway obstruction with a post-bronchodilator FEV1 ≥ 30 % and < 80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1.

3. Male or female patients, 40 years of age or older.

4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years

5. Patients must be able to: perform technically acceptable pulmonary function tests, and maintain records(paper diary).

6. Patients must be able to inhale medication in a competent manner from the Respimat Inhaler as well as the Handihaler.

Exclusion Criteria

1. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patients ability to participate in the study.

2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an AST >x2 ULN, ALT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients).

3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count ≥600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.

4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists).

5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists).

6. A history of myocardial infarction within 1 year of screening visit (Visit 1).

7. Unstable or life-threatening cardiac arrhythmia.

8. Hospitalization for heart failure within the past year.

9. Known active tuberculosis.

10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).

11. A history of life-threatening pulmonary obstruction.

12. A history of cystic fibrosis.

13. Clinically evident bronchiectasis.

14. A history of significant alcohol or drug abuse.

15. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1).

16. Patients being treated with oral or patch ß-adrenergics.

17. Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.

18. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits.

19. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program.

20. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).

21. Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the Respimat® inhalation solution.

22. Patients with known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler®.

23. Pregnant or nursing women.

24. Women of childbearing potential not using a highly effective method of birth control*. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.

• as per ICH M3(R2) a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year).

25. Patients who have previously been randomised in this study or are currently participating in another study.

26. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1222.52.02090 Boehringer Ingelheim Investigational Site

Anniston, Alabama, United States

1222.52.02046 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1222.52.02014 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

1222.52.02017 Boehringer Ingelheim Investigational Site

Montgomery, Alabama, United States

1222.52.02092 Boehringer Ingelheim Investigational Site

Anchorage, Alaska, United States

1222.52.02072 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

1222.52.02063 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

1222.52.02088 Boehringer Ingelheim Investigational Site

Peoria, Arizona, United States

1222.52.02012 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

1222.52.02006 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

1222.52.02031 Boehringer Ingelheim Investigational Site

San Jose, California, United States

1222.52.02011 Boehringer Ingelheim Investigational Site

Torrance, California, United States

1222.52.02061 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

1222.52.02054 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

1222.52.02001 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

1222.52.02037 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

1222.52.02055 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

1222.52.02094 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

1222.52.02022 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

1222.52.02074 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

1222.52.02016 Boehringer Ingelheim Investigational Site

Ponte Verda, Florida, United States

1222.52.02084 Boehringer Ingelheim Investigational Site

Saint Petersberg, Florida, United States

1222.52.02043 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1222.52.02009 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

1222.52.02048 Boehringer Ingelheim Investigational Site

Duluth, Georgia, United States

1222.52.02077 Boehringer Ingelheim Investigational Site

Gainsville, Georgia, United States

1222.52.02040 Boehringer Ingelheim Investigational Site

Rincon, Georgia, United States

1222.52.02024 Boehringer Ingelheim Investigational Site

O'Fallon, Illinois, United States

1222.52.02002 Boehringer Ingelheim Investigational Site

Muncie, Indiana, United States

1222.52.02008 Boehringer Ingelheim Investigational Site

Fort Mitchell, Kentucky, United States

1222.52.02025 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

1222.52.02089 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

1222.52.02005 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

1222.52.02029 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

1222.52.02036 Boehringer Ingelheim Investigational Site

Hollywood, Maryland, United States

1222.52.02015 Boehringer Ingelheim Investigational Site

Townson, Maryland, United States

1222.52.02034 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

1222.52.02003 Boehringer Ingelheim Investigational Site

Chelsea, Michigan, United States

1222.52.02020 Boehringer Ingelheim Investigational Site

Kalamazoo, Michigan, United States

1222.52.02047 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

1222.52.02049 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

1222.52.02079 Boehringer Ingelheim Investigational Site

Plymouth, Minnesota, United States

1222.52.02068 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

1222.52.02028 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1222.52.02053 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1222.52.02050 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

1222.52.02035 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

1222.52.02030 Boehringer Ingelheim Investigational Site

Marlton, New Jersey, United States

1222.52.02071 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

1222.52.02064 Boehringer Ingelheim Investigational Site

Johnson City, New York, United States

1222.52.02087 Boehringer Ingelheim Investigational Site

New Windsor, New York, United States

1222.52.02091 Boehringer Ingelheim Investigational Site

Syracuse, New York, United States

1222.52.02076 Boehringer Ingelheim Investigational Site

Calabash, North Carolina, United States

1222.52.02010 Boehringer Ingelheim Investigational Site

Huntersville, North Carolina, United States

1222.52.02045 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

1222.52.02038 Boehringer Ingelheim Investigational Site

Salisbury, North Carolina, United States

1222.52.02051 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

1222.52.02058 Boehringer Ingelheim Investigational Site

Tabor City, North Carolina, United States

1222.52.02013 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

1222.52.02062 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

1222.52.02039 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

1222.52.02081 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

1222.52.02093 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

1222.52.02059 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

1222.52.02026 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

1222.52.02097 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

1222.52.02075 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

1222.52.02102 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

1222.52.02080 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

1222.52.02100 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

1222.52.02096 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

1222.52.02085 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

1222.52.02101 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

1222.52.02065 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

1222.52.02042 Boehringer Ingelheim Investigational Site

Myrtle Beach, South Carolina, United States

1222.52.02083 Boehringer Ingelheim Investigational Site

Rock Hill, South Carolina, United States

1222.52.02066 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

1222.52.02095 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

1222.52.02098 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

1222.52.02018 Boehringer Ingelheim Investigational Site

Brentwood, Tennessee, United States

1222.52.02086 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

1222.52.02044 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

1222.52.02041 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

1222.52.02027 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

1222.52.02056 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

1222.52.02007 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1222.52.02060 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1222.52.02078 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

1222.52.02082 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

1222.52.02057 Boehringer Ingelheim Investigational Site

Midvale, Utah, United States

1222.52.02023 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

1222.52.02069 Boehringer Ingelheim Investigational Site

Selah, Washington, United States

1222.52.02019 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

1222.52.02099 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Countries

United States

References

ZuWallack R, Allen L, Hernandez G, Ting N, Abrahams R. Efficacy and safety of combining olodaterol Respimat((R)) and tiotropium HandiHaler((R)) in patients with COPD: results of two randomized, double-blind, active-controlled studies. Int J Chron Obstruct Pulmon Dis. 2014 Oct 14;9:1133-44. doi: 10.2147/COPD.S72482. eCollection 2014.

Reference Type: DERIVED

PMID: 25342898 (View on PubMed)

Other Identifiers

1222.52

Identifier Type: -

Identifier Source: org_study_id