Back to results

Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

olodaterol (BI 1744) low

low tiotropium bromide

olodaterol (BI 1744) high

medium tiotropium bromide

high tiotropium bromide

Placebo

Respimat

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
All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:

a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years

Exclusion criteria:

Patients with a significant disease other than COPD;
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
Patients with a history of asthma or a total blood eosinophil count >=600/mm3.
Patients with any of the following conditions:

a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years

Patients who have undergone thoracotomy with pulmonary resection
Patients being treated with the following concomitant medications:

medications that prolong the QT/QTc interval oral Beta-adrenergics 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

- Pregnant or nursing women

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

olodaterol (BI 1744) low and placebo

olodaterol (BI 1744) low and low tio

olodaterol (BI 1744) low and medium tio

olodaterol (BI 1744) low and high tio

olodaterol (BI 1744) high and placebo

Olodaterol (BI 1744) high and low tio

Olodaterol (BI 1744) high and medium tio

Olodaterol (BI 1744) high and high tio

Arm Description

low dose inhaled olodaterol orally once daily from the Respimat inhaler

low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

high dose inhaled olodaterol orally once daily from the Respimat inhaler

high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Outcomes

Primary Outcome Measures

Trough FEV1 Response

Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

Secondary Outcome Measures

Trough Forced Vital Capacity (FVC) Response

Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FEV1 AUC 0-3h and FEV1 AUC 0-6h Response

Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FEV1 AUC 0-3h Response After the First Dose

Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FEV1 Peak 0-3h Response

Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FEV1 Peak 0-3h Response After the First Dose

Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FVC AUC 0-3h and FEV1 AUC 0-6h Responses

Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FVC AUC 0-3h Response After First Dose

Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FVC Peak 0-3h Response

Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

FVC Peak 0-3h Response After the First Dose

Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

PEF AUC 0-3h and AUC 0-6h Responses

Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

PEF AUC 0-3h Response After the First Dose

Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

PEF Peak 0-3h Response

Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

PEF Peak 0-3h Response After the First Dose

Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

Individual FEV1 Measurements at Each Time Point on Day 29

Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

Individual FVC Measurements at Each Time Point on Day 29

Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

Individual PEF Measurements at Each Time Point on Day 29

Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

Weekly Mean Number of Puffs of Rescue Medication Used Per Day

Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).

Physicians Global Evaluation

Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29. The score was evaluated on a 8-points scale : Poor : 1,2 Fair : 3,4 Good : 5,6 Excellent : 7,8

Patients Global Rating

Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29. The score was evaluated on a 7-point scale : 1 : very much better 2 : much better 3 : a little better 4 : no change 5 : a little worse 6 : much worse 7 : very much worse

Pulse Rate Recorded in Conjunction With Spirometry

Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).

Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry

Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).

Full Information

NCT ID

NCT01040403

First Posted

December 28, 2009

Last Updated

June 19, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01040403

Brief Title

Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

Official Title

A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment 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 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

233 (Actual)

8. Arms, Groups, and Interventions

Arm Title

olodaterol (BI 1744) low and placebo

Arm Type

Experimental

Arm Description

low dose inhaled olodaterol orally once daily from the Respimat inhaler

Arm Title

olodaterol (BI 1744) low and low tio

Arm Type

Experimental

Arm Description

low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

Arm Title

olodaterol (BI 1744) low and medium tio

Arm Type

Experimental

Arm Description

low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

Arm Title

olodaterol (BI 1744) low and high tio

Arm Type

Experimental

Arm Description

low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Arm Title

olodaterol (BI 1744) high and placebo

Arm Type

Experimental

Arm Description

high dose inhaled olodaterol orally once daily from the Respimat inhaler

Arm Title

Olodaterol (BI 1744) high and low tio

Arm Type

Experimental

Arm Description

high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

Arm Title

Olodaterol (BI 1744) high and medium tio

Arm Type

Experimental

Arm Description

high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

Arm Title

Olodaterol (BI 1744) high and high tio

Arm Type

Experimental

Arm Description

high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Intervention Type

Drug

Intervention Name(s)

olodaterol (BI 1744) low

Intervention Description

olodaterol (BI 1744) low

Intervention Type

Drug

Intervention Name(s)

low tiotropium bromide

Intervention Description

low tiotropium bromide

Intervention Type

Drug

Intervention Name(s)

olodaterol (BI 1744) high

Intervention Description

olodaterol (BI 1744) high

Intervention Type

Drug

Intervention Name(s)

medium tiotropium bromide

Intervention Description

medium tiotropium bromide

Intervention Type

Drug

Intervention Name(s)

high tiotropium bromide

Intervention Description

high tiotropium bromide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Device

Intervention Name(s)

Respimat

Intervention Description

Respimat inhaler

Primary Outcome Measure Information:

Title

Trough FEV1 Response

Description

Time Frame

Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29

Secondary Outcome Measure Information:

Title

Trough Forced Vital Capacity (FVC) Response

Description

Time Frame

Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29

Title

FEV1 AUC 0-3h and FEV1 AUC 0-6h Response

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29

Title

FEV1 AUC 0-3h Response After the First Dose

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

Title

FEV1 Peak 0-3h Response

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29

Title

FEV1 Peak 0-3h Response After the First Dose

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

Title

FVC AUC 0-3h and FEV1 AUC 0-6h Responses

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29

Title

FVC AUC 0-3h Response After First Dose

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1

Title

FVC Peak 0-3h Response

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29

Title

FVC Peak 0-3h Response After the First Dose

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

Title

PEF AUC 0-3h and AUC 0-6h Responses

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29

Title

PEF AUC 0-3h Response After the First Dose

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

Title

PEF Peak 0-3h Response

Description

Time Frame

Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29

Title

PEF Peak 0-3h Response After the First Dose

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

Title

Individual FEV1 Measurements at Each Time Point on Day 29

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29

Title

Individual FVC Measurements at Each Time Point on Day 29

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29

Title

Individual PEF Measurements at Each Time Point on Day 29

Description

Time Frame

Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29

Title

Weekly Mean Number of Puffs of Rescue Medication Used Per Day

Description

Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).

Time Frame

Weeks 1 and 4

Title

Physicians Global Evaluation

Description

Time Frame

Days 1 and 29

Title

Patients Global Rating

Description

Time Frame

Day 29

Title

Pulse Rate Recorded in Conjunction With Spirometry

Description

Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).

Time Frame

Baseline and 30 min post-dose on day 29

Title

Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry

Description

Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).

Time Frame

Baseline and 30 min post-dose on day 29

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 All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria: a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years Exclusion criteria: Patients with a significant disease other than COPD; Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; Patients with a history of asthma or a total blood eosinophil count >=600/mm3. Patients with any of the following conditions: a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years Patients who have undergone thoracotomy with pulmonary resection Patients being treated with the following concomitant medications: medications that prolong the QT/QTc interval oral Beta-adrenergics 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 - Pregnant or nursing women

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

1237.18.02004 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1237.18.02005 Boehringer Ingelheim Investigational Site

City

Grimsby

State/Province

Ontario

Country

Canada

Facility Name

1237.18.02001 Boehringer Ingelheim Investigational Site

City

Mississauga

State/Province

Ontario

Country

Canada

Facility Name

1237.18.02008 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1237.18.02002 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1237.18.02003 Boehringer Ingelheim Investigational Site

City

Point Claire

State/Province

Quebec

Country

Canada

Facility Name

1237.18.02007 Boehringer Ingelheim Investigational Site

City

Sherbrooke

State/Province

Quebec

Country

Canada

Facility Name

1237.18.02011 Boehringer Ingelheim Investigational Site

City

Saskatoon

State/Province

Saskatchewan

Country

Canada

Facility Name

1237.18.02009 Boehringer Ingelheim Investigational Site

City

Quebec

Country

Canada

Facility Name

1237.18.49009 Boehringer Ingelheim Investigational Site

City

Aschaffenburg

Country

Germany

Facility Name

1237.18.49012 Boehringer Ingelheim Investigational Site

City

Bamberg

Country

Germany

Facility Name

1237.18.49005 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1237.18.49004 Boehringer Ingelheim Investigational Site

City

Frankfurt

Country

Germany

Facility Name

1237.18.49011 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1237.18.49010 Boehringer Ingelheim Investigational Site

City

Koblenz

Country

Germany

Facility Name

1237.18.49007 Boehringer Ingelheim Investigational Site

City

Mannheim

Country

Germany

Facility Name

1237.18.49001 Boehringer Ingelheim Investigational Site

City

Potsdam

Country

Germany

Facility Name

1237.18.49006 Boehringer Ingelheim Investigational Site

City

Rodgau-Dudenhofen

Country

Germany

Facility Name

1237.18.49002 Boehringer Ingelheim Investigational Site

City

Rüdersdorf

Country

Germany

Facility Name

1237.18.49003 Boehringer Ingelheim Investigational Site

City

Weinheim

Country

Germany

Facility Name

1237.18.49008 Boehringer Ingelheim Investigational Site

City

Wiesloch

Country

Germany

Facility Name

1237.18.31004 Boehringer Ingelheim Investigational Site

City

Almelo

Country

Netherlands

Facility Name

1237.18.31006 Boehringer Ingelheim Investigational Site

City

Amsterdam

Country

Netherlands

Facility Name

1237.18.31008 Boehringer Ingelheim Investigational Site

City

Eindhoven

Country

Netherlands

Facility Name

1237.18.31001 Boehringer Ingelheim Investigational Site

City

Groningen

Country

Netherlands

Facility Name

1237.18.31007 Boehringer Ingelheim Investigational Site

City

Hengelo

Country

Netherlands

Facility Name

1237.18.31005 Boehringer Ingelheim Investigational Site

City

Hoorn

Country

Netherlands

Facility Name

1237.18.31002 Boehringer Ingelheim Investigational Site

City

Veldhoven

Country

Netherlands

Facility Name

1237.18.31003 Boehringer Ingelheim Investigational Site

City

Zutphen

Country

Netherlands

Facility Name

1237.18.46003 Boehringer Ingelheim Investigational Site

City

Boden

Country

Sweden

Facility Name

1237.18.46002 Boehringer Ingelheim Investigational Site

City

Göteborg

Country

Sweden

Facility Name

1237.18.46001 Boehringer Ingelheim Investigational Site

City

Lund

Country

Sweden

Facility Name

1237.18.46004 Boehringer Ingelheim Investigational Site

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

26404912

Citation

Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.

Results Reference

derived

Links:

URL

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

Description

Related Info

Learn more about this trial

Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

We'll reach out to this number within 24 hrs

Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

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