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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

Tiotropium

Olodaterol

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 andTiotropium

Placebo and Tiotropium

Arm Description

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

2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by 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. AUC was standardized by dividing by time unit.

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

Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data

The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores [dichotomous (true/false) except last question (4-point Likert scale)]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate - study - will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.

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 change from baseline. All p-values for these measures are only descriptive.

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. AUC was standardized by dividing by time unit.

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

Peak FVC 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.

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). Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)

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 metered dose inhaler (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. Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)

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. Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)

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. Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline. Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)

Full Information

NCT ID

NCT01696058

First Posted

September 26, 2012

Last Updated

November 13, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01696058

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 2]

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 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

1137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olodaterol andTiotropium

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

marketed product

Intervention Type

Drug

Intervention Name(s)

Placebo matching Olodaterol

Intervention Description

one dose

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

marketed product

Intervention Type

Drug

Intervention Name(s)

Olodaterol

Intervention Description

one 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. AUC was standardized by dividing by time unit.

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

Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data

Description

Time Frame

12 weeks

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 change from baseline. All p-values for these measures are only descriptive.

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. AUC was standardized by dividing by time unit.

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

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

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

1222.52.02090 Boehringer Ingelheim Investigational Site

City

Anniston

State/Province

Alabama

Country

United States

Facility Name

1222.52.02046 Boehringer Ingelheim Investigational Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

1222.52.02014 Boehringer Ingelheim Investigational Site

City

Mobile

State/Province

Alabama

Country

United States

Facility Name

1222.52.02017 Boehringer Ingelheim Investigational Site

City

Montgomery

State/Province

Alabama

Country

United States

Facility Name

1222.52.02092 Boehringer Ingelheim Investigational Site

City

Anchorage

State/Province

Alaska

Country

United States

Facility Name

1222.52.02072 Boehringer Ingelheim Investigational Site

City

Chandler

State/Province

Arizona

Country

United States

Facility Name

1222.52.02063 Boehringer Ingelheim Investigational Site

City

Glendale

State/Province

Arizona

Country

United States

Facility Name

1222.52.02088 Boehringer Ingelheim Investigational Site

City

Peoria

State/Province

Arizona

Country

United States

Facility Name

1222.52.02012 Boehringer Ingelheim Investigational Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

1222.52.02006 Boehringer Ingelheim Investigational Site

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

1222.52.02031 Boehringer Ingelheim Investigational Site

City

San Jose

State/Province

California

Country

United States

Facility Name

1222.52.02011 Boehringer Ingelheim Investigational Site

City

Torrance

State/Province

California

Country

United States

Facility Name

1222.52.02061 Boehringer Ingelheim Investigational Site

City

Boulder

State/Province

Colorado

Country

United States

Facility Name

1222.52.02054 Boehringer Ingelheim Investigational Site

City

Fort Collins

State/Province

Colorado

Country

United States

Facility Name

1222.52.02001 Boehringer Ingelheim Investigational Site

City

Hartford

State/Province

Connecticut

Country

United States

Facility Name

1222.52.02037 Boehringer Ingelheim Investigational Site

City

Norwalk

State/Province

Connecticut

Country

United States

Facility Name

1222.52.02055 Boehringer Ingelheim Investigational Site

City

Waterbury

State/Province

Connecticut

Country

United States

Facility Name

1222.52.02094 Boehringer Ingelheim Investigational Site

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

1222.52.02022 Boehringer Ingelheim Investigational Site

City

Fort Lauderdale

State/Province

Florida

Country

United States

Facility Name

1222.52.02074 Boehringer Ingelheim Investigational Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

1222.52.02016 Boehringer Ingelheim Investigational Site

City

Ponte Verda

State/Province

Florida

Country

United States

Facility Name

1222.52.02084 Boehringer Ingelheim Investigational Site

City

St. Petersberg

State/Province

Florida

Country

United States

Facility Name

1222.52.02043 Boehringer Ingelheim Investigational Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

1222.52.02009 Boehringer Ingelheim Investigational Site

City

Blue Ridge

State/Province

Georgia

Country

United States

Facility Name

1222.52.02048 Boehringer Ingelheim Investigational Site

City

Duluth

State/Province

Georgia

Country

United States

Facility Name

1222.52.02077 Boehringer Ingelheim Investigational Site

City

Gainsville

State/Province

Georgia

Country

United States

Facility Name

1222.52.02040 Boehringer Ingelheim Investigational Site

City

Rincon

State/Province

Georgia

Country

United States

Facility Name

1222.52.02024 Boehringer Ingelheim Investigational Site

City

O'Fallon

State/Province

Illinois

Country

United States

Facility Name

1222.52.02002 Boehringer Ingelheim Investigational Site

City

Muncie

State/Province

Indiana

Country

United States

Facility Name

1222.52.02008 Boehringer Ingelheim Investigational Site

City

Fort Mitchell

State/Province

Kentucky

Country

United States

Facility Name

1222.52.02025 Boehringer Ingelheim Investigational Site

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

1222.52.02089 Boehringer Ingelheim Investigational Site

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

1222.52.02005 Boehringer Ingelheim Investigational Site

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

1222.52.02029 Boehringer Ingelheim Investigational Site

City

Columbia

State/Province

Maryland

Country

United States

Facility Name

1222.52.02036 Boehringer Ingelheim Investigational Site

City

Hollywood

State/Province

Maryland

Country

United States

Facility Name

1222.52.02015 Boehringer Ingelheim Investigational Site

City

Townson

State/Province

Maryland

Country

United States

Facility Name

1222.52.02034 Boehringer Ingelheim Investigational Site

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

1222.52.02003 Boehringer Ingelheim Investigational Site

City

Chelsea

State/Province

Michigan

Country

United States

Facility Name

1222.52.02020 Boehringer Ingelheim Investigational Site

City

Kalamazoo

State/Province

Michigan

Country

United States

Facility Name

1222.52.02047 Boehringer Ingelheim Investigational Site

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

1222.52.02049 Boehringer Ingelheim Investigational Site

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

1222.52.02079 Boehringer Ingelheim Investigational Site

City

Plymouth

State/Province

Minnesota

Country

United States

Facility Name

1222.52.02068 Boehringer Ingelheim Investigational Site

City

Chesterfield

State/Province

Missouri

Country

United States

Facility Name

1222.52.02028 Boehringer Ingelheim Investigational Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

1222.52.02053 Boehringer Ingelheim Investigational Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

1222.52.02050 Boehringer Ingelheim Investigational Site

City

Billings

State/Province

Montana

Country

United States

Facility Name

1222.52.02035 Boehringer Ingelheim Investigational Site

City

Henderson

State/Province

Nevada

Country

United States

Facility Name

1222.52.02030 Boehringer Ingelheim Investigational Site

City

Marlton

State/Province

New Jersey

Country

United States

Facility Name

1222.52.02071 Boehringer Ingelheim Investigational Site

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

1222.52.02064 Boehringer Ingelheim Investigational Site

City

Johnson City

State/Province

New York

Country

United States

Facility Name

1222.52.02087 Boehringer Ingelheim Investigational Site

City

New Windsor

State/Province

New York

Country

United States

Facility Name

1222.52.02091 Boehringer Ingelheim Investigational Site

City

Syracuse

State/Province

New York

Country

United States

Facility Name

1222.52.02076 Boehringer Ingelheim Investigational Site

City

Calabash

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02010 Boehringer Ingelheim Investigational Site

City

Huntersville

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02045 Boehringer Ingelheim Investigational Site

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02038 Boehringer Ingelheim Investigational Site

City

Salisbury

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02051 Boehringer Ingelheim Investigational Site

City

Shelby

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02058 Boehringer Ingelheim Investigational Site

City

Tabor City

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02013 Boehringer Ingelheim Investigational Site

City

Winston Salem

State/Province

North Carolina

Country

United States

Facility Name

1222.52.02062 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

1222.52.02039 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

1222.52.02081 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

1222.52.02093 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

1222.52.02059 Boehringer Ingelheim Investigational Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

1222.52.02026 Boehringer Ingelheim Investigational Site

City

Medford

State/Province

Oregon

Country

United States

Facility Name

1222.52.02097 Boehringer Ingelheim Investigational Site

City

Medford

State/Province

Oregon

Country

United States

Facility Name

1222.52.02075 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1222.52.02102 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1222.52.02080 Boehringer Ingelheim Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

1222.52.02100 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02096 Boehringer Ingelheim Investigational Site

City

Easley

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02085 Boehringer Ingelheim Investigational Site

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02101 Boehringer Ingelheim Investigational Site

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02065 Boehringer Ingelheim Investigational Site

City

Hodges

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02042 Boehringer Ingelheim Investigational Site

City

Myrtle Beach

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02083 Boehringer Ingelheim Investigational Site

City

Rock Hill

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02066 Boehringer Ingelheim Investigational Site

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02095 Boehringer Ingelheim Investigational Site

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02098 Boehringer Ingelheim Investigational Site

City

Union

State/Province

South Carolina

Country

United States

Facility Name

1222.52.02018 Boehringer Ingelheim Investigational Site

City

Brentwood

State/Province

Tennessee

Country

United States

Facility Name

1222.52.02086 Boehringer Ingelheim Investigational Site

City

Arlington

State/Province

Texas

Country

United States

Facility Name

1222.52.02044 Boehringer Ingelheim Investigational Site

City

Austin

State/Province

Texas

Country

United States

Facility Name

1222.52.02041 Boehringer Ingelheim Investigational Site

City

El Paso

State/Province

Texas

Country

United States

Facility Name

1222.52.02027 Boehringer Ingelheim Investigational Site

City

Fort Worth

State/Province

Texas

Country

United States

Facility Name

1222.52.02056 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1222.52.02007 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1222.52.02060 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1222.52.02078 Boehringer Ingelheim Investigational Site

City

Sugar Land

State/Province

Texas

Country

United States

Facility Name

1222.52.02082 Boehringer Ingelheim Investigational Site

City

Waco

State/Province

Texas

Country

United States

Facility Name

1222.52.02057 Boehringer Ingelheim Investigational Site

City

Midvale

State/Province

Utah

Country

United States

Facility Name

1222.52.02023 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1222.52.02069 Boehringer Ingelheim Investigational Site

City

Selah

State/Province

Washington

Country

United States

Facility Name

1222.52.02019 Boehringer Ingelheim Investigational Site

City

Tacoma

State/Province

Washington

Country

United States

Facility Name

1222.52.02099 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

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

Related Info

Learn more about this trial

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

Learn more about this trial