Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

NCT01694771 | Completed Phase 3 Results

• 1 other identifier: 1222.51
• Study Type: interventional
• Target: 1,134
• Locations: 1 country
• Sites: 90

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

Outcome Measures

Primary Outcomes (2)

• FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12

  FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12

  baseline and 12 weeks

• Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12

  Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12

  baseline and 12 weeks

Secondary Outcomes (8)

• Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline

  baseline and 12 weeks

• FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline

  baseline and 12 weeks

• Trough FVC Response at 12 Weeks- Defined as Change From Baseline

  baseline and 12 weeks

• Peak FVC Response at 12 Weeks - Defined as Change From Baseline

  baseline and 12 weeks

• Rescue Medication Usage - Percentage of Rescue Free Days

  over 12 weeks

Study Arms (2)

Olodaterol and Tiotropium

EXPERIMENTAL

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

Drug: Olodaterol; Drug: Tiotropium

Placebo and Tiotropium

OTHER

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

Drug: Tiotropium; Drug: Placebo matching Olodaterol

Interventions

Tiotropium DRUG

Marketed dose

Placebo and Tiotropium

Placebo matching Olodaterol DRUG

One dose

Placebo and Tiotropium

Olodaterol DRUG

One dose

Olodaterol and Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Male or female patients, 40 years of age or older.
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years
• Patients must be able to: perform technically acceptable pulmonary function tests, and maintain records(paper diary).
• Patients must be able to inhale medication in a competent manner from the Respimat Inhaler as well as the Handihaler.

You may not qualify if:

• 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.
• 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).
• 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.
• A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists).
• A diagnosis of paroxysmal tachycardia (\>100 beats per minute) (due to the known class side effect profile of ß2-agonists).
• A history of myocardial infarction within 1 year of screening visit (Visit 1).
• Unstable or life-threatening cardiac arrhythmia.
• Hospitalization for heart failure within the past year.
• Known active tuberculosis.
• A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).
• A history of life-threatening pulmonary obstruction.
• A history of cystic fibrosis.
• Clinically evident bronchiectasis.
• A history of significant alcohol or drug abuse.
• Patients being treated with oral or patch ß-adrenergics.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (90)

1222.51.01055 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

Location

1222.51.01087 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

1222.51.01066 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1222.51.01069 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Location

1222.51.01040 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Location

1222.51.01064 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

1222.51.01060 Boehringer Ingelheim Investigational Site

Fullerton, California, United States

Location

1222.51.01084 Boehringer Ingelheim Investigational Site

Lincoln, California, United States

Location

1222.51.01041 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1222.51.01094 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1222.51.01015 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

1222.51.01052 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

1222.51.01010 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.51.01042 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.51.01070 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

1222.51.01006 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1222.51.01021 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1222.51.01082 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1222.51.01065 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1222.51.01051 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1222.51.01092 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1222.51.01081 Boehringer Ingelheim Investigational Site

Ormond Beach, Florida, United States

Location

1222.51.01054 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

1222.51.01062 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Location

1222.51.01088 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1222.51.01079 Boehringer Ingelheim Investigational Site

Tamarac, Florida, United States

Location

1222.51.01075 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1222.51.01076 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Location

1222.51.01057 Boehringer Ingelheim Investigational Site

Duluth, Georgia, United States

Location

1222.51.01086 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Location

1222.51.01019 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1222.51.01027 Boehringer Ingelheim Investigational Site

Eagle, Idaho, United States

Location

1222.51.01048 Boehringer Ingelheim Investigational Site

Arlingron Heights, Illinois, United States

Location

1222.51.01044 Boehringer Ingelheim Investigational Site

River Forest, Illinois, United States

Location

1222.51.01043 Boehringer Ingelheim Investigational Site

Skokie, Illinois, United States

Location

1222.51.01090 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1222.51.01023 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

1222.51.01071 Boehringer Ingelheim Investigational Site

Opelousas, Louisiana, United States

Location

1222.51.01050 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1222.51.01049 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

1222.51.01025 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Location

1222.51.01078 Boehringer Ingelheim Investigational Site

Edina, Minnesota, United States

Location

1222.51.01033 Boehringer Ingelheim Investigational Site

Fridley, Minnesota, United States

Location

1222.51.01074 Boehringer Ingelheim Investigational Site

Saint Charles, Missouri, United States

Location

1222.51.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1222.51.01039 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Location

1222.51.01045 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Location

1222.51.01018 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

1222.51.01014 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

Location

1222.51.01077 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1222.51.01056 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Location

1222.51.01032 Boehringer Ingelheim Investigational Site

Canton, Ohio, United States

Location

1222.51.01011 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1222.51.01005 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1222.51.01093 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1222.51.01089 Boehringer Ingelheim Investigational Site

Sylvania, Ohio, United States

Location

1222.51.01080 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1222.51.01017 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1222.51.01047 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1222.51.01031 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Location

1222.51.01020 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

1222.51.01053 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1222.51.01016 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Location

1222.51.01004 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1222.51.01030 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

1222.51.01009 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

Location

1222.51.01036 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1222.51.01061 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Location

1222.51.01038 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1222.51.01046 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1222.51.01022 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Location

1222.51.01063 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1222.51.01013 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1222.51.01024 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1222.51.01012 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

1222.51.01008 Boehringer Ingelheim Investigational Site

Rapid City, South Dakota, United States

Location

1222.51.01035 Boehringer Ingelheim Investigational Site

Johnson City, Tennessee, United States

Location

1222.51.01028 Boehringer Ingelheim Investigational Site

Boerne, Texas, United States

Location

1222.51.01083 Boehringer Ingelheim Investigational Site

Corsicana, Texas, United States

Location

1222.51.01085 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1222.51.01073 Boehringer Ingelheim Investigational Site

Longview, Texas, United States

Location

1222.51.01003 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1222.51.01058 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Location

1222.51.01068 Boehringer Ingelheim Investigational Site

Abingdon, Virginia, United States

Location

1222.51.01029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1222.51.01034 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1222.51.01072 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1222.51.01091 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1222.51.01002 Boehringer Ingelheim Investigational Site

Vancouver, Washington, United States

Location

1222.51.01001 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 25342898 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 4, 2014
• Results First Posted: September 4, 2014

Record last verified: 2014-08

Locations

US (90)