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Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

NCT ID: NCT01694771

Last Updated: 2014-09-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Olodaterol and Tiotropium

2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered

Group Type EXPERIMENTAL

Olodaterol

Intervention Type DRUG

One dose

Tiotropium

Intervention Type DRUG

Marketed dose

Placebo and Tiotropium

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

Group Type OTHER

Tiotropium

Intervention Type DRUG

Marketed dose

Placebo matching Olodaterol

Intervention Type DRUG

One dose

Interventions

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Tiotropium

Marketed dose

Intervention Type DRUG

Placebo matching Olodaterol

One dose

Intervention Type DRUG

Olodaterol

One dose

Intervention Type DRUG

Tiotropium

Marketed dose

Intervention Type DRUG

Eligibility Criteria

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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

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1222.51.01055 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

Site Status

1222.51.01087 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1222.51.01066 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1222.51.01069 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Site Status

1222.51.01040 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Site Status

1222.51.01064 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Site Status

1222.51.01060 Boehringer Ingelheim Investigational Site

Fullerton, California, United States

Site Status

1222.51.01084 Boehringer Ingelheim Investigational Site

Lincoln, California, United States

Site Status

1222.51.01041 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1222.51.01094 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1222.51.01015 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Site Status

1222.51.01052 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Site Status

1222.51.01010 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1222.51.01042 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1222.51.01070 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1222.51.01006 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1222.51.01021 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1222.51.01082 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1222.51.01065 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1222.51.01051 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

1222.51.01092 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

1222.51.01081 Boehringer Ingelheim Investigational Site

Ormond Beach, Florida, United States

Site Status

1222.51.01054 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

1222.51.01062 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Site Status

1222.51.01088 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

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1222.51.01079 Boehringer Ingelheim Investigational Site

Tamarac, Florida, United States

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1222.51.01075 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1222.51.01076 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Site Status

1222.51.01057 Boehringer Ingelheim Investigational Site

Duluth, Georgia, United States

Site Status

1222.51.01086 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Site Status

1222.51.01019 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

1222.51.01027 Boehringer Ingelheim Investigational Site

Eagle, Idaho, United States

Site Status

1222.51.01048 Boehringer Ingelheim Investigational Site

Arlingron Heights, Illinois, United States

Site Status

1222.51.01044 Boehringer Ingelheim Investigational Site

River Forest, Illinois, United States

Site Status

1222.51.01043 Boehringer Ingelheim Investigational Site

Skokie, Illinois, United States

Site Status

1222.51.01090 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Site Status

1222.51.01023 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Site Status

1222.51.01071 Boehringer Ingelheim Investigational Site

Opelousas, Louisiana, United States

Site Status

1222.51.01050 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1222.51.01049 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

1222.51.01025 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Site Status

1222.51.01078 Boehringer Ingelheim Investigational Site

Edina, Minnesota, United States

Site Status

1222.51.01033 Boehringer Ingelheim Investigational Site

Fridley, Minnesota, United States

Site Status

1222.51.01074 Boehringer Ingelheim Investigational Site

Saint Charles, Missouri, United States

Site Status

1222.51.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1222.51.01039 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Site Status

1222.51.01045 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Site Status

1222.51.01018 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

1222.51.01014 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

Site Status

1222.51.01077 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

1222.51.01056 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Site Status

1222.51.01032 Boehringer Ingelheim Investigational Site

Canton, Ohio, United States

Site Status

1222.51.01011 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1222.51.01005 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1222.51.01093 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Site Status

1222.51.01089 Boehringer Ingelheim Investigational Site

Sylvania, Ohio, United States

Site Status

1222.51.01080 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1222.51.01017 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1222.51.01047 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Site Status

1222.51.01031 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Site Status

1222.51.01020 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

1222.51.01053 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1222.51.01016 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Site Status

1222.51.01004 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1222.51.01030 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Site Status

1222.51.01009 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

Site Status

1222.51.01036 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1222.51.01061 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Site Status

1222.51.01038 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Site Status

1222.51.01046 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

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1222.51.01022 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Site Status

1222.51.01063 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1222.51.01013 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1222.51.01024 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1222.51.01012 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

1222.51.01008 Boehringer Ingelheim Investigational Site

Rapid City, South Dakota, United States

Site Status

1222.51.01035 Boehringer Ingelheim Investigational Site

Johnson City, Tennessee, United States

Site Status

1222.51.01028 Boehringer Ingelheim Investigational Site

Boerne, Texas, United States

Site Status

1222.51.01083 Boehringer Ingelheim Investigational Site

Corsicana, Texas, United States

Site Status

1222.51.01085 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1222.51.01073 Boehringer Ingelheim Investigational Site

Longview, Texas, United States

Site Status

1222.51.01003 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1222.51.01058 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Site Status

1222.51.01068 Boehringer Ingelheim Investigational Site

Abingdon, Virginia, United States

Site Status

1222.51.01029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1222.51.01034 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1222.51.01072 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1222.51.01091 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1222.51.01002 Boehringer Ingelheim Investigational Site

Vancouver, Washington, United States

Site Status

1222.51.01001 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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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

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1222.51

Identifier Type: -

Identifier Source: org_study_id

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