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Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tiotropium

Placebo matching Olodaterol

Olodaterol

Tiotropium

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

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 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).
Patients being treated with oral or patch ß-adrenergics.
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.
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.
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.
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).
Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the Respimat® inhalation solution.
Patients with known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler®.
Pregnant or nursing women.
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).
Patients who have previously been randomised in this study or are currently participating in another study.
Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Olodaterol and Tiotropium

Placebo and Tiotropium

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline

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

Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.

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

Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.

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

Peak FVC response at 12 weeks - defined as change from baseline.

Rescue Medication Usage - Percentage of Rescue Free Days

Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).

Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)

Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.

Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)

Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.

Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)

Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.

Full Information

NCT ID

NCT01694771

First Posted

September 25, 2012

Last Updated

August 25, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01694771

Brief Title

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Official Title

A Randomised, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-administration of Olodaterol 5µg (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) in Patients With Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 1]

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olodaterol and Tiotropium

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo and Tiotropium

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Marketed dose

Intervention Type

Drug

Intervention Name(s)

Placebo matching Olodaterol

Intervention Description

One dose

Intervention Type

Drug

Intervention Name(s)

Olodaterol

Intervention Description

One dose

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Marketed dose

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

baseline and 12 weeks

Title

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

Description

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

Time Frame

baseline and 12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline

Time Frame

baseline and 12 weeks

Title

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

Description

Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.

Time Frame

baseline and 12 weeks

Title

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

Description

Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.

Time Frame

baseline and 12 weeks

Title

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

Description

Peak FVC response at 12 weeks - defined as change from baseline.

Time Frame

baseline and 12 weeks

Title

Rescue Medication Usage - Percentage of Rescue Free Days

Description

Time Frame

over 12 weeks

Title

Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)

Description

Time Frame

over 12 weeks

Title

Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)

Description

Time Frame

over 12 weeks

Title

Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)

Description

Time Frame

over 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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 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). Patients being treated with oral or patch ß-adrenergics. 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. 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. 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. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1). Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the Respimat® inhalation solution. Patients with known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler®. Pregnant or nursing women. 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). Patients who have previously been randomised in this study or are currently participating in another study. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1222.51.01055 Boehringer Ingelheim Investigational Site

City

Florence

State/Province

Alabama

Country

United States

Facility Name

1222.51.01087 Boehringer Ingelheim Investigational Site

City

Jasper

State/Province

Alabama

Country

United States

Facility Name

1222.51.01066 Boehringer Ingelheim Investigational Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

1222.51.01069 Boehringer Ingelheim Investigational Site

City

Scottsdale

State/Province

Arizona

Country

United States

Facility Name

1222.51.01040 Boehringer Ingelheim Investigational Site

City

Anaheim

State/Province

California

Country

United States

Facility Name

1222.51.01064 Boehringer Ingelheim Investigational Site

City

Encinitas

State/Province

California

Country

United States

Facility Name

1222.51.01060 Boehringer Ingelheim Investigational Site

City

Fullerton

State/Province

California

Country

United States

Facility Name

1222.51.01084 Boehringer Ingelheim Investigational Site

City

Lincoln

State/Province

California

Country

United States

Facility Name

1222.51.01041 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1222.51.01094 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1222.51.01015 Boehringer Ingelheim Investigational Site

City

Torrance

State/Province

California

Country

United States

Facility Name

1222.51.01052 Boehringer Ingelheim Investigational Site

City

Boulder

State/Province

Colorado

Country

United States

Facility Name

1222.51.01010 Boehringer Ingelheim Investigational Site

City

Wheat Ridge

State/Province

Colorado

Country

United States

Facility Name

1222.51.01042 Boehringer Ingelheim Investigational Site

City

Wheat Ridge

State/Province

Colorado

Country

United States

Facility Name

1222.51.01070 Boehringer Ingelheim Investigational Site

City

Stamford

State/Province

Connecticut

Country

United States

Facility Name

1222.51.01006 Boehringer Ingelheim Investigational Site

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

1222.51.01021 Boehringer Ingelheim Investigational Site

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

1222.51.01082 Boehringer Ingelheim Investigational Site

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

1222.51.01065 Boehringer Ingelheim Investigational Site

City

DeLand

State/Province

Florida

Country

United States

Facility Name

1222.51.01051 Boehringer Ingelheim Investigational Site

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

1222.51.01092 Boehringer Ingelheim Investigational Site

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

1222.51.01081 Boehringer Ingelheim Investigational Site

City

Ormond Beach

State/Province

Florida

Country

United States

Facility Name

1222.51.01054 Boehringer Ingelheim Investigational Site

City

Panama City

State/Province

Florida

Country

United States

Facility Name

1222.51.01062 Boehringer Ingelheim Investigational Site

City

Pensacola

State/Province

Florida

Country

United States

Facility Name

1222.51.01088 Boehringer Ingelheim Investigational Site

City

Port Orange

State/Province

Florida

Country

United States

Facility Name

1222.51.01079 Boehringer Ingelheim Investigational Site

City

Tamarac

State/Province

Florida

Country

United States

Facility Name

1222.51.01075 Boehringer Ingelheim Investigational Site

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

1222.51.01076 Boehringer Ingelheim Investigational Site

City

Austell

State/Province

Georgia

Country

United States

Facility Name

1222.51.01057 Boehringer Ingelheim Investigational Site

City

Duluth

State/Province

Georgia

Country

United States

Facility Name

1222.51.01086 Boehringer Ingelheim Investigational Site

City

Lawrenceville

State/Province

Georgia

Country

United States

Facility Name

1222.51.01019 Boehringer Ingelheim Investigational Site

City

Coeur d'Alene

State/Province

Idaho

Country

United States

Facility Name

1222.51.01027 Boehringer Ingelheim Investigational Site

City

Eagle

State/Province

Idaho

Country

United States

Facility Name

1222.51.01048 Boehringer Ingelheim Investigational Site

City

Arlingron Heights

State/Province

Illinois

Country

United States

Facility Name

1222.51.01044 Boehringer Ingelheim Investigational Site

City

River Forest

State/Province

Illinois

Country

United States

Facility Name

1222.51.01043 Boehringer Ingelheim Investigational Site

City

Skokie

State/Province

Illinois

Country

United States

Facility Name

1222.51.01090 Boehringer Ingelheim Investigational Site

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

1222.51.01023 Boehringer Ingelheim Investigational Site

City

Lafayette

State/Province

Louisiana

Country

United States

Facility Name

1222.51.01071 Boehringer Ingelheim Investigational Site

City

Opelousas

State/Province

Louisiana

Country

United States

Facility Name

1222.51.01050 Boehringer Ingelheim Investigational Site

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

1222.51.01049 Boehringer Ingelheim Investigational Site

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

1222.51.01025 Boehringer Ingelheim Investigational Site

City

Livonia

State/Province

Michigan

Country

United States

Facility Name

1222.51.01078 Boehringer Ingelheim Investigational Site

City

Edina

State/Province

Minnesota

Country

United States

Facility Name

1222.51.01033 Boehringer Ingelheim Investigational Site

City

Fridley

State/Province

Minnesota

Country

United States

Facility Name

1222.51.01074 Boehringer Ingelheim Investigational Site

City

St. Charles

State/Province

Missouri

Country

United States

Facility Name

1222.51.01037 Boehringer Ingelheim Investigational Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

1222.51.01039 Boehringer Ingelheim Investigational Site

City

Reno

State/Province

Nevada

Country

United States

Facility Name

1222.51.01045 Boehringer Ingelheim Investigational Site

City

Larchmont

State/Province

New York

Country

United States

Facility Name

1222.51.01018 Boehringer Ingelheim Investigational Site

City

Rochester

State/Province

New York

Country

United States

Facility Name

1222.51.01014 Boehringer Ingelheim Investigational Site

City

Asheville

State/Province

North Carolina

Country

United States

Facility Name

1222.51.01077 Boehringer Ingelheim Investigational Site

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

1222.51.01056 Boehringer Ingelheim Investigational Site

City

Greensboro

State/Province

North Carolina

Country

United States

Facility Name

1222.51.01032 Boehringer Ingelheim Investigational Site

City

Canton

State/Province

Ohio

Country

United States

Facility Name

1222.51.01011 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

1222.51.01005 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

1222.51.01093 Boehringer Ingelheim Investigational Site

City

Dayton

State/Province

Ohio

Country

United States

Facility Name

1222.51.01089 Boehringer Ingelheim Investigational Site

City

Sylvania

State/Province

Ohio

Country

United States

Facility Name

1222.51.01080 Boehringer Ingelheim Investigational Site

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

1222.51.01017 Boehringer Ingelheim Investigational Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

1222.51.01047 Boehringer Ingelheim Investigational Site

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

1222.51.01031 Boehringer Ingelheim Investigational Site

City

Corvallis

State/Province

Oregon

Country

United States

Facility Name

1222.51.01020 Boehringer Ingelheim Investigational Site

City

Medford

State/Province

Oregon

Country

United States

Facility Name

1222.51.01053 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

1222.51.01016 Boehringer Ingelheim Investigational Site

City

Erie

State/Province

Pennsylvania

Country

United States

Facility Name

1222.51.01004 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1222.51.01030 Boehringer Ingelheim Investigational Site

City

East Providence

State/Province

Rhode Island

Country

United States

Facility Name

1222.51.01009 Boehringer Ingelheim Investigational Site

City

Johnston

State/Province

Rhode Island

Country

United States

Facility Name

1222.51.01036 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01061 Boehringer Ingelheim Investigational Site

City

Columbia

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01038 Boehringer Ingelheim Investigational Site

City

Easley

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01046 Boehringer Ingelheim Investigational Site

City

Easley

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01022 Boehringer Ingelheim Investigational Site

City

Gaffney

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01063 Boehringer Ingelheim Investigational Site

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01013 Boehringer Ingelheim Investigational Site

City

Greer

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01024 Boehringer Ingelheim Investigational Site

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01012 Boehringer Ingelheim Investigational Site

City

Union

State/Province

South Carolina

Country

United States

Facility Name

1222.51.01008 Boehringer Ingelheim Investigational Site

City

Rapid City

State/Province

South Dakota

Country

United States

Facility Name

1222.51.01035 Boehringer Ingelheim Investigational Site

City

Johnson City

State/Province

Tennessee

Country

United States

Facility Name

1222.51.01028 Boehringer Ingelheim Investigational Site

City

Boerne

State/Province

Texas

Country

United States

Facility Name

1222.51.01083 Boehringer Ingelheim Investigational Site

City

Corsicana

State/Province

Texas

Country

United States

Facility Name

1222.51.01085 Boehringer Ingelheim Investigational Site

City

Killeen

State/Province

Texas

Country

United States

Facility Name

1222.51.01073 Boehringer Ingelheim Investigational Site

City

Longview

State/Province

Texas

Country

United States

Facility Name

1222.51.01003 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1222.51.01058 Boehringer Ingelheim Investigational Site

City

Murray

State/Province

Utah

Country

United States

Facility Name

1222.51.01068 Boehringer Ingelheim Investigational Site

City

Abingdon

State/Province

Virginia

Country

United States

Facility Name

1222.51.01029 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1222.51.01034 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1222.51.01072 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1222.51.01091 Boehringer Ingelheim Investigational Site

City

Spokane

State/Province

Washington

Country

United States

Facility Name

1222.51.01002 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

Washington

Country

United States

Facility Name

1222.51.01001 Boehringer Ingelheim Investigational Site

City

Morgantown

State/Province

West Virginia

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25342898

Citation

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.

Results Reference

derived

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Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

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Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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