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Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

placebo

tiotropium Respimat® low dose

placebo

tiotropium Respimat® high dose

50 mcg salmeterol HFA MDI

placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
Male or female patients aged at least 18 years but not more than 75 years.
All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5.
The initial diagnosis of asthma must have been made before the patient's age of 40.
The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL.
All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5.

8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.

9. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.

10. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years.

11. Patients must be able to use the Respimat® inhaler and metered dose inhaler correctly.

12. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter.

Exclusion criteria:

Patients with a significant disease other than asthma. 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 trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1.
Patients with a recent history (i.e. six months or less) of myocardial infarction.
Patients who have been hospitalised for cardiac failure during the past year.
Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
Patients with lung diseases other than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
Patients with known active tuberculosis.
Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
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 with significant alcohol or drug abuse within the past two years.
Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).
Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other components of the study medication delivery systems.
Pregnant or nursing woman.
Women of childbearing potential not using a highly effective method of birth control.
Patients who have taken an investigational drug within four weeks prior to Visit 1.
Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed.
Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period.
Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period.
Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
Patients with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period.
Patients who have previously been randomised in this trial or in the respective twin trial (205.418) or are currently participating in another trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

tiotropium low dose

tiotropium high dose

50 mcg salmeterol

placebo

Arm Description

Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)

Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)

Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI

Outcomes

Primary Outcome Measures

Peak FEV1 Within 3 Hours Post-dose Response

Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

Trough FEV1 Response

Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.

Secondary Outcome Measures

Peak FVC Within 3 Hours Post-dose Response

Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

Trough FVC Response

Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response

Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.

FVC Area Under Curve 0-3 Hours (AUC0-3h) Response

Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.

Trough PEF Response

Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

Total Asthma Quality of Life Questionnaire (AQLQs)) Score

Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items and ranges from from 1 (highest intensity) till 7 (no symptoms). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

Total Asthma Control Questionnaire (ACQ) Score

Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items and ranges from from 0 (no symptoms) till 6 (highest intensity). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

The Responder Rate as Assessed by the ACQ

The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points.The score ranges from 0 (no impairment) to 6 (maximum impairment).

Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24

Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week

Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24

PEF Variability

PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24

Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24

Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24

Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24

Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)

Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)

Full Information

NCT ID

NCT01172821

First Posted

July 26, 2010

Last Updated

June 3, 2014

Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01172821

Brief Title

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II

Official Title

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

4. Oversight

5. Study Description

Brief Summary

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

6. Conditions and Keywords

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

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1032 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tiotropium low dose

Arm Type

Experimental

Arm Description

Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)

Arm Title

tiotropium high dose

Arm Type

Experimental

Arm Description

Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)

Arm Title

50 mcg salmeterol

Arm Type

Active Comparator

Arm Description

Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo that represents BI drug

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo that represents comparator

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo that represents comparator

Intervention Type

Drug

Intervention Name(s)

tiotropium Respimat® low dose

Intervention Description

IMP

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo that represents BI drug

Intervention Type

Drug

Intervention Name(s)

tiotropium Respimat® high dose

Intervention Description

IMP

Intervention Type

Drug

Intervention Name(s)

50 mcg salmeterol HFA MDI

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo that represents comparator

Primary Outcome Measure Information:

Title

Peak FEV1 Within 3 Hours Post-dose Response

Description

Time Frame

24 weeks

Title

Trough FEV1 Response

Description

Time Frame

24 weeks

Title

The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Peak FVC Within 3 Hours Post-dose Response

Description

Time Frame

24 weeks

Title

Trough FVC Response

Description

Time Frame

24 weeks

Title

FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response

Description

Time Frame

24 weeks

Title

FVC Area Under Curve 0-3 Hours (AUC0-3h) Response

Description

Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.

Time Frame

24 weeks

Title

Trough PEF Response

Description

Time Frame

24 weeks

Title

Total Asthma Quality of Life Questionnaire (AQLQs)) Score

Description

Time Frame

24 weeks

Title

Total Asthma Control Questionnaire (ACQ) Score

Description

Time Frame

24 weeks

Title

The Responder Rate as Assessed by the ACQ

Description

Time Frame

24 weeks

Title

Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24

Description

Time Frame

Baseline and last 7 days before week 24 visit

Title

Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24

Description

Time Frame

Baseline and last 7 days before week 24 visit

Title

PEF Variability

Description

Time Frame

Last 7 days before week 24 visit

Title

Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24

Description

Time Frame

Baseline and last 7 days before week 24 visit

Title

Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24

Description

Time Frame

Baseline and last 7 days before week 24 visit

Title

Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24

Description

Time Frame

Baseline and last 7 days before week 24 visit

Title

Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24

Description

Time Frame

Baseline and last 7 days before week 24 visit

Title

Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

Description

Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)

Time Frame

24 weeks

Title

Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1). Male or female patients aged at least 18 years but not more than 75 years. All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5. The initial diagnosis of asthma must have been made before the patient's age of 40. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5. 8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1. 9. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%. 10. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years. 11. Patients must be able to use the Respimat® inhaler and metered dose inhaler correctly. 12. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter. Exclusion criteria: Patients with a significant disease other than asthma. 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 trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial. Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1. Patients with a recent history (i.e. six months or less) of myocardial infarction. Patients who have been hospitalised for cardiac failure during the past year. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. Patients with lung diseases other than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD)). Patients with known active tuberculosis. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 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 with significant alcohol or drug abuse within the past two years. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening). Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other components of the study medication delivery systems. Pregnant or nursing woman. Women of childbearing potential not using a highly effective method of birth control. Patients who have taken an investigational drug within four weeks prior to Visit 1. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period. Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period. Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period. Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period. Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period. Patients with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period. Patients who have previously been randomised in this trial or in the respective twin trial (205.418) or are currently participating in another trial.

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

205.419.01058 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

205.419.01053 Boehringer Ingelheim Investigational Site

City

Stockton

State/Province

California

Country

United States

Facility Name

205.419.01061 Boehringer Ingelheim Investigational Site

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

205.419.01066 Boehringer Ingelheim Investigational Site

City

Denver

State/Province

Colorado

Country

United States

Facility Name

205.419.01064 Boehringer Ingelheim Investigational Site

City

Panama City

State/Province

Florida

Country

United States

Facility Name

205.419.01060 Boehringer Ingelheim Investigational Site

City

Winter Park

State/Province

Florida

Country

United States

Facility Name

205.419.01068 Boehringer Ingelheim Investigational Site

City

Novi

State/Province

Michigan

Country

United States

Facility Name

205.419.01054 Boehringer Ingelheim Investigational Site

City

Plymouth

State/Province

Minnesota

Country

United States

Facility Name

205.419.01062 Boehringer Ingelheim Investigational Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

205.419.01070 Boehringer Ingelheim Investigational Site

City

Bozeman

State/Province

Montana

Country

United States

Facility Name

205.419.01067 Boehringer Ingelheim Investigational Site

City

Skillman

State/Province

New Jersey

Country

United States

Facility Name

205.419.01071 Boehringer Ingelheim Investigational Site

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

205.419.01055 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

205.419.01065 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

205.419.01069 Boehringer Ingelheim Investigational Site

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

205.419.01056 Boehringer Ingelheim Investigational Site

City

Union

State/Province

South Carolina

Country

United States

Facility Name

205.419.01063 Boehringer Ingelheim Investigational Site

City

El Paso

State/Province

Texas

Country

United States

Facility Name

205.419.01051 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

205.419.55053 Boehringer Ingelheim Investigational Site

City

Florianopolis

Country

Brazil

Facility Name

205.419.55054 Boehringer Ingelheim Investigational Site

City

Porto Alegre

Country

Brazil

Facility Name

205.419.55052 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.419.55055 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.419.86061 Boehringer Ingelheim Investigational Site

City

Chengdu

Country

China

Facility Name

205.419.86053 Boehringer Ingelheim Investigational Site

City

Chongqing

Country

China

Facility Name

205.419.86056 Boehringer Ingelheim Investigational Site

City

Guangzhou

Country

China

Facility Name

205.419.86062 Boehringer Ingelheim Investigational Site

City

Guangzhou

Country

China

Facility Name

205.419.86054 Boehringer Ingelheim Investigational Site

City

Haikou

Country

China

Facility Name

205.419.86059 Boehringer Ingelheim Investigational Site

City

Kunming

Country

China

Facility Name

205.419.86058 Boehringer Ingelheim Investigational Site

City

Nanchang

Country

China

Facility Name

205.419.86064 Boehringer Ingelheim Investigational Site

City

Nanjing

Country

China

Facility Name

205.419.86051 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

205.419.86052 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

205.419.86055 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

205.419.86066 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

205.419.86057 Boehringer Ingelheim Investigational Site

City

Xi'An

Country

China

Facility Name

205.419.86065 Boehringer Ingelheim Investigational Site

City

Xi'An

Country

China

Facility Name

205.419.86063 Boehringer Ingelheim Investigational Site

City

Xuzhou

Country

China

Facility Name

205.419.86067 Boehringer Ingelheim Investigational Site

City

Yangzhou

Country

China

Facility Name

205.419.86068 Boehringer Ingelheim Investigational Site

City

Yinchuan

Country

China

Facility Name

205.419.57051 Boehringer Ingelheim Investigational Site

City

Bogota

Country

Colombia

Facility Name

205.419.57052 Boehringer Ingelheim Investigational Site

City

Bogota

Country

Colombia

Facility Name

205.419.57053 Boehringer Ingelheim Investigational Site

City

Bogota

Country

Colombia

Facility Name

205.419.57054 Boehringer Ingelheim Investigational Site

City

Medelin

Country

Colombia

Facility Name

205.419.49061 Boehringer Ingelheim Investigational Site

City

Bamberg

Country

Germany

Facility Name

205.419.49051 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.419.49052 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.419.49062 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.419.49063 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.419.49064 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.419.49054 Boehringer Ingelheim Investigational Site

City

Frankfurt

Country

Germany

Facility Name

205.419.49058 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

205.419.49057 Boehringer Ingelheim Investigational Site

City

Koblenz

Country

Germany

Facility Name

205.419.49056 Boehringer Ingelheim Investigational Site

City

Lübeck

Country

Germany

Facility Name

205.419.49059 Boehringer Ingelheim Investigational Site

City

Rüdersdorf

Country

Germany

Facility Name

205.419.49053 Boehringer Ingelheim Investigational Site

City

Wiesbaden

Country

Germany

Facility Name

205.419.49055 Boehringer Ingelheim Investigational Site

City

Witten

Country

Germany

Facility Name

205.419.91057 Boehringer Ingelheim Investigational Site

City

Ahmedabad

Country

India

Facility Name

205.419.91056 Boehringer Ingelheim Investigational Site

City

Coimbatore

Country

India

Facility Name

205.419.91055 Boehringer Ingelheim Investigational Site

City

Hyderabad

Country

India

Facility Name

205.419.91051 Boehringer Ingelheim Investigational Site

City

Jaipur

Country

India

Facility Name

205.419.91058 Boehringer Ingelheim Investigational Site

City

Jaipur

Country

India

Facility Name

205.419.91054 Boehringer Ingelheim Investigational Site

City

Mumbai

Country

India

Facility Name

205.419.91059 Boehringer Ingelheim Investigational Site

City

Mysore

Country

India

Facility Name

205.419.91053 Boehringer Ingelheim Investigational Site

City

Nagpur

Country

India

Facility Name

205.419.81085 Boehringer Ingelheim Investigational Site

City

Aira, Kagoshima

Country

Japan

Facility Name

205.419.81062 Boehringer Ingelheim Investigational Site

City

Chuo-ku, Tokyo

Country

Japan

Facility Name

205.419.81073 Boehringer Ingelheim Investigational Site

City

Fukuoka, Fukuoka

Country

Japan

Facility Name

205.419.81074 Boehringer Ingelheim Investigational Site

City

Fukuoka, Fukuoka

Country

Japan

Facility Name

205.419.81072 Boehringer Ingelheim Investigational Site

City

Fukuyama, Hiroshima

Country

Japan

Facility Name

205.419.81069 Boehringer Ingelheim Investigational Site

City

Habikino, Osaka

Country

Japan

Facility Name

205.419.81071 Boehringer Ingelheim Investigational Site

City

Hiroshima, Hiroshima

Country

Japan

Facility Name

205.419.81058 Boehringer Ingelheim Investigational Site

City

Itabashi-ku, Tokyo

Country

Japan

Facility Name

205.419.81064 Boehringer Ingelheim Investigational Site

City

Iwata, Shizuoka

Country

Japan

Facility Name

205.419.81063 Boehringer Ingelheim Investigational Site

City

Kanazawa, Ishikawa

Country

Japan

Facility Name

205.419.81054 Boehringer Ingelheim Investigational Site

City

Kishiwada, Osaka

Country

Japan

Facility Name

205.419.81075 Boehringer Ingelheim Investigational Site

City

Kitakyushu, Fukuoka

Country

Japan

Facility Name

205.419.81070 Boehringer Ingelheim Investigational Site

City

Kobe, Hyogo

Country

Japan

Facility Name

205.419.81061 Boehringer Ingelheim Investigational Site

City

Koto-ku, Tokyo

Country

Japan

Facility Name

205.419.81067 Boehringer Ingelheim Investigational Site

City

Kyoto, Kyoto

Country

Japan

Facility Name

205.419.81080 Boehringer Ingelheim Investigational Site

City

Matsusaka, Mie

Country

Japan

Facility Name

205.419.81081 Boehringer Ingelheim Investigational Site

City

Meguro-ku, Tokyo

Country

Japan

Facility Name

205.419.81060 Boehringer Ingelheim Investigational Site

City

Minato-ku, Tokyo

Country

Japan

Facility Name

205.419.81077 Boehringer Ingelheim Investigational Site

City

Minato-ku, Tokyo

Country

Japan

Facility Name

205.419.81056 Boehringer Ingelheim Investigational Site

City

Morioka, Iwate

Country

Japan

Facility Name

205.419.81055 Boehringer Ingelheim Investigational Site

City

Naka-gun, Ibaraki

Country

Japan

Facility Name

205.419.81078 Boehringer Ingelheim Investigational Site

City

Nakano-ku,Tokyo

Country

Japan

Facility Name

205.419.81084 Boehringer Ingelheim Investigational Site

City

Oita,Oita

Country

Japan

Facility Name

205.419.81068 Boehringer Ingelheim Investigational Site

City

Osaka-Sayama, Osaka

Country

Japan

Facility Name

205.419.81053 Boehringer Ingelheim Investigational Site

City

Sapporo, Hokkaido

Country

Japan

Facility Name

205.419.81057 Boehringer Ingelheim Investigational Site

City

Sendai, Miyagi

Country

Japan

Facility Name

205.419.81059 Boehringer Ingelheim Investigational Site

City

Seto, Aichi

Country

Japan

Facility Name

205.419.81082 Boehringer Ingelheim Investigational Site

City

Shinagawa-ku, Tokyo

Country

Japan

Facility Name

205.419.81065 Boehringer Ingelheim Investigational Site

City

Shizuoka, Shizuoka

Country

Japan

Facility Name

205.419.81066 Boehringer Ingelheim Investigational Site

City

Toyota, Aichi

Country

Japan

Facility Name

205.419.81051 Boehringer Ingelheim Investigational Site

City

Urasoe, Okinawa

Country

Japan

Facility Name

205.419.81052 Boehringer Ingelheim Investigational Site

City

Urasoe, Okinawa

Country

Japan

Facility Name

205.419.81076 Boehringer Ingelheim Investigational Site

City

Urasoe, Okinawa

Country

Japan

Facility Name

205.419.81083 Boehringer Ingelheim Investigational Site

City

Yokohama, Kanagawa

Country

Japan

Facility Name

205.419.81079 Boehringer Ingelheim Investigational Site

City

Yotsukaido, Chiba

Country

Japan

Facility Name

205.419.52051 Boehringer Ingelheim Investigational Site

City

Mexico City

Country

Mexico

Facility Name

205.419.52052 Boehringer Ingelheim Investigational Site

City

Mexico City

Country

Mexico

Facility Name

205.419.52053 Boehringer Ingelheim Investigational Site

City

Monterrey

Country

Mexico

Facility Name

205.419.51051 Boehringer Ingelheim Investigational Site

City

Lima

Country

Peru

Facility Name

205.419.51052 Boehringer Ingelheim Investigational Site

City

Lima

Country

Peru

Facility Name

205.419.51053 Boehringer Ingelheim Investigational Site

City

Lima

Country

Peru

Facility Name

205.419.51054 Boehringer Ingelheim Investigational Site

City

Lima

Country

Peru

Facility Name

205.419.51055 Boehringer Ingelheim Investigational Site

City

Lima

Country

Peru

Facility Name

205.419.48052 Boehringer Ingelheim Investigational Site

City

Bialystok

Country

Poland

Facility Name

205.419.48054 Boehringer Ingelheim Investigational Site

City

Bydgoszcz

Country

Poland

Facility Name

205.419.48055 Boehringer Ingelheim Investigational Site

City

Gorzow Wielkopolski

Country

Poland

Facility Name

205.419.48051 Boehringer Ingelheim Investigational Site

City

Krakow

Country

Poland

Facility Name

205.419.48057 Boehringer Ingelheim Investigational Site

City

Poznan

Country

Poland

Facility Name

205.419.48058 Boehringer Ingelheim Investigational Site

City

Sopot

Country

Poland

Facility Name

205.419.48053 Boehringer Ingelheim Investigational Site

City

Wloszczowa

Country

Poland

Facility Name

205.419.48056 Boehringer Ingelheim Investigational Site

City

Wroclaw

Country

Poland

Facility Name

205.419.40055 Boehringer Ingelheim Investigational Site

City

Brasov

Country

Romania

Facility Name

205.419.40056 Boehringer Ingelheim Investigational Site

City

Brasov

Country

Romania

Facility Name

205.419.40052 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

205.419.40053 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

205.419.40054 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

205.419.40058 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

205.419.40060 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

205.419.40051 Boehringer Ingelheim Investigational Site

City

Bucuresti

Country

Romania

Facility Name

205.419.40059 Boehringer Ingelheim Investigational Site

City

Constanta

Country

Romania

Facility Name

205.419.40057 Boehringer Ingelheim Investigational Site

City

Iasi

Country

Romania

12. IPD Sharing Statement

Citations:

PubMed Identifier

32180164

Citation

Halpin DMG, Hamelmann EH, Frith PA, Moroni-Zentgraf PM, van Hecke B, Unseld A, Kerstjens HAM, Szefler SJ. Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis. Pulm Ther. 2020 Jun;6(1):131-140. doi: 10.1007/s41030-020-00113-w. Epub 2020 Mar 16.

Results Reference

derived

PubMed Identifier

31654891

Citation

Casale TB, Aalbers R, Bleecker ER, Meltzer EO, Zaremba-Pechmann L, de la Hoz A, Kerstjens HAM. Tiotropium Respimat(R) add-on therapy to inhaled corticosteroids in patients with symptomatic asthma improves clinical outcomes regardless of baseline characteristics. Respir Med. 2019 Oct-Nov;158:97-109. doi: 10.1016/j.rmed.2019.09.014. Epub 2019 Sep 30.

Results Reference

derived

PubMed Identifier

31319851

Citation

Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6.

Results Reference

derived

PubMed Identifier

29174062

Citation

Casale TB, Bateman ED, Vandewalker M, Virchow JC, Schmidt H, Engel M, Moroni-Zentgraf P, Kerstjens HAM. Tiotropium Respimat Add-on Is Efficacious in Symptomatic Asthma, Independent of T2 Phenotype. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):923-935.e9. doi: 10.1016/j.jaip.2017.08.037. Epub 2017 Nov 22.

Results Reference

derived

PubMed Identifier

25682232

Citation

Kerstjens HA, Casale TB, Bleecker ER, Meltzer EO, Pizzichini E, Schmidt O, Engel M, Bour L, Verkleij CB, Moroni-Zentgraf P, Bateman ED. Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials. Lancet Respir Med. 2015 May;3(5):367-76. doi: 10.1016/S2213-2600(15)00031-4. Epub 2015 Feb 12.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.419_U12-2467-01-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.419_Literature.pdf

Description

Related Info

Learn more about this trial

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Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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