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A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo twice daily

Olodaterol low daily dose twice daily

Olodaterol medium daily dose twice daily

Placebo twice daily

Olodaterol high daily dose once daily and placebo

Olodaterol medium daily dose once daily and placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients of either sex.
Aged 18 to 70 years.
A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4.
Prebronchodilator Forced Expiratory Volume in one second (FEV1) >= 60% predicted and < 90% predicted according to European Coal and Steel Community (ECSC).
Increase in FEV1 >=12% and >=200 mL 15 min. after 400 µg salbutamol (albuterol);
Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at least 48 hours prior to Visit 1b.

Exclusion criteria:

Patients with a significant disease other than asthma.
History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years).
Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.
Oral or other systemic corticosteroids in the past 6 weeks.
Patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Olodaterol medium daily dose

Olodaterol high daily dose

Arm Description

Olodaterol medium daily dose given either as once daily or split into two low doses daily or placebo only in randomised sequence of three cross-over treatment phases

Olodaterol high daily dose given either as once daily or split into two medium doses daily or placebo only in randomised sequence of three cross-over treatment phases

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.

Secondary Outcome Measures

FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

Peak FEV1 Within 24 Hours Post-dose Response

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

Trough FEV1 Response

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

Peak FVC Within 24 Hours Post-dose Response

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post-dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

Trough FVC Response

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FVC values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

Peak PEF Within 24 Hours Post-dose Response

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

Trough PEF Response

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 PEF values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

Mean Pre-dose Morning PEF (PEF a.m.)

PEF a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.

Mean Pre-dose Evening PEF (PEF p.m.)

PEF p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.

PEF Daily Variability

PEF daily variability was assessed by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.

Mean Pre-dose Morning FEV1 (FEV1 a.m.)

FEV1 a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.

Mean Pre-dose Evening FEV1 (FEV1 p.m.)

FEV1 p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.

Mean Number of Puffs of Rescue Medication During the Whole Day

Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM3 device (overall mean number obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.

Percentage of Asthma Symptom Free Days

Percentage of asthma-symptom free days of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM3 device.

Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)

Assessed by patients at home using the AM3 device during each period of randomised treatment.

Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)

Assessed by patients at home using the AM3 device during each period of randomised treatment .

Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)

Assessed by patients at home using the AM3 device during each period of randomised treatment.

Total Asthma Control Questionnaire (ACQ) Score

Control of asthma as assessed by the ACQ at the end of each 3-week treatment period.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.

Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event reporting includes 12 days into the subsequent washout or post-treatment period.

Full Information

NCT ID

NCT01311661

First Posted

March 4, 2011

Last Updated

March 28, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01311661

Brief Title

A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

Official Title

Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, Delivered With the Respimat® Inhaler, After 3 Weeks of Olodaterol Once Daily Medium Dose, Twice Daily Low Dose and Placebo or After 3 Weeks of Once Daily High Dose, Twice Daily Medium Dose and Placebo Administration in Patients With Moderate to Severe Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

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 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olodaterol medium daily dose

Arm Type

Experimental

Arm Description

Olodaterol medium daily dose given either as once daily or split into two low doses daily or placebo only in randomised sequence of three cross-over treatment phases

Arm Title

Olodaterol high daily dose

Arm Type

Experimental

Arm Description

Olodaterol high daily dose given either as once daily or split into two medium doses daily or placebo only in randomised sequence of three cross-over treatment phases

Intervention Type

Drug

Intervention Name(s)

Placebo twice daily

Intervention Description

Inhaled Placebo of Olodaterol twice daily

Intervention Type

Drug

Intervention Name(s)

Olodaterol low daily dose twice daily

Intervention Description

Inhaled Olodaterol medium daily dose administered as low dose twice daily

Intervention Type

Drug

Intervention Name(s)

Olodaterol medium daily dose twice daily

Intervention Description

Inhaled Olodaterol high daily dose administered as medium dose twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo twice daily

Intervention Description

Inhaled Placebo of Olodaterol twice daily

Intervention Type

Drug

Intervention Name(s)

Olodaterol high daily dose once daily and placebo

Intervention Description

Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily

Intervention Type

Drug

Intervention Name(s)

Olodaterol medium daily dose once daily and placebo

Intervention Description

Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily

Primary Outcome Measure Information:

Title

Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Secondary Outcome Measure Information:

Title

FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period

Description

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks

Title

FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period

Description

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Peak FEV1 Within 24 Hours Post-dose Response

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Trough FEV1 Response

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks

Title

FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response

Description

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response

Description

Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Peak FVC Within 24 Hours Post-dose Response

Description

Time Frame

Title

Trough FVC Response

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min related to morning dose after 3 weeks

Title

PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response

Description

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response

Description

Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Peak PEF Within 24 Hours Post-dose Response

Description

Time Frame

Title

Trough PEF Response

Description

Time Frame

1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks

Title

Mean Pre-dose Morning PEF (PEF a.m.)

Description

Time Frame

0-3 weeks

Title

Mean Pre-dose Evening PEF (PEF p.m.)

Description

Time Frame

0-3 weeks

Title

PEF Daily Variability

Description

Time Frame

0-3 weeks

Title

Mean Pre-dose Morning FEV1 (FEV1 a.m.)

Description

Time Frame

0-3 weeks

Title

Mean Pre-dose Evening FEV1 (FEV1 p.m.)

Description

Time Frame

0-3 weeks

Title

Mean Number of Puffs of Rescue Medication During the Whole Day

Description

Time Frame

0-3 weeks

Title

Percentage of Asthma Symptom Free Days

Description

Time Frame

0-3 weeks

Title

Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)

Description

Assessed by patients at home using the AM3 device during each period of randomised treatment.

Time Frame

0-3 weeks

Title

Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)

Description

Assessed by patients at home using the AM3 device during each period of randomised treatment .

Time Frame

0-3 weeks

Title

Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)

Description

Assessed by patients at home using the AM3 device during each period of randomised treatment.

Time Frame

0-3 weeks

Title

Total Asthma Control Questionnaire (ACQ) Score

Description

Time Frame

3 weeks

Title

Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

Description

Time Frame

3 weeks + 12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients of either sex. Aged 18 to 70 years. A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4. Prebronchodilator Forced Expiratory Volume in one second (FEV1) >= 60% predicted and < 90% predicted according to European Coal and Steel Community (ECSC). Increase in FEV1 >=12% and >=200 mL 15 min. after 400 µg salbutamol (albuterol); Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at least 48 hours prior to Visit 1b. Exclusion criteria: Patients with a significant disease other than asthma. History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years). Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b. Oral or other systemic corticosteroids in the past 6 weeks. Patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.

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

1222.29.11006 Boehringer Ingelheim Investigational Site

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

1222.29.11001 Boehringer Ingelheim Investigational Site

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

1222.29.11012 Boehringer Ingelheim Investigational Site

City

Wheat Ridge

State/Province

Colorado

Country

United States

Facility Name

1222.29.11002 Boehringer Ingelheim Investigational Site

City

Overland Park

State/Province

Kansas

Country

United States

Facility Name

1222.29.11004 Boehringer Ingelheim Investigational Site

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

1222.29.11011 Boehringer Ingelheim Investigational Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

1222.29.11009 Boehringer Ingelheim Investigational Site

City

Skillman

State/Province

New Jersey

Country

United States

Facility Name

1222.29.11003 Boehringer Ingelheim Investigational Site

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

1222.29.11008 Boehringer Ingelheim Investigational Site

City

Canton

State/Province

Ohio

Country

United States

Facility Name

1222.29.11007 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

1222.29.11005 Boehringer Ingelheim Investigational Site

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

1222.29.11010 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1222.29.43003 Boehringer Ingelheim Investigational Site

City

Linz

Country

Austria

Facility Name

1222.29.43002 Boehringer Ingelheim Investigational Site

City

Schlüsslberg

Country

Austria

Facility Name

1222.29.43001 Boehringer Ingelheim Investigational Site

City

Thalheim bei Wels

Country

Austria

Facility Name

1222.29.43004 Boehringer Ingelheim Investigational Site

City

Wels

Country

Austria

Facility Name

1222.29.49004 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1222.29.49006 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1222.29.49007 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1222.29.49008 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1222.29.49002 Boehringer Ingelheim Investigational Site

City

Frankfurt

Country

Germany

Facility Name

1222.29.49010 Boehringer Ingelheim Investigational Site

City

Großhansdorf

Country

Germany

Facility Name

1222.29.49003 Boehringer Ingelheim Investigational Site

City

Lübeck

Country

Germany

Facility Name

1222.29.49005 Boehringer Ingelheim Investigational Site

City

Rüdersdorf

Country

Germany

Facility Name

1222.29.49001 Boehringer Ingelheim Investigational Site

City

Wiesbaden

Country

Germany

Facility Name

1222.29.49009 Boehringer Ingelheim Investigational Site

City

Wiesloch

Country

Germany

Facility Name

1222.29.36002 Boehringer Ingelheim Investigational Site

City

Mosonmagyarovar

Country

Hungary

Facility Name

1222.29.36003 Boehringer Ingelheim Investigational Site

City

Nyiregyhaza

Country

Hungary

Facility Name

1222.29.36001 Boehringer Ingelheim Investigational Site

City

Sopron

Country

Hungary

Facility Name

1222.29.36004 Boehringer Ingelheim Investigational Site

City

Zalaegerszeg

Country

Hungary

Facility Name

1222.29.42001 Boehringer Ingelheim Investigational Site

City

Bardejov

Country

Slovakia

Facility Name

1222.29.42002 Boehringer Ingelheim Investigational Site

City

Martin

Country

Slovakia

Facility Name

1222.29.42004 Boehringer Ingelheim Investigational Site

City

Nitra

Country

Slovakia

Facility Name

1222.29.42003 Boehringer Ingelheim Investigational Site

City

Spisska Nova Ves

Country

Slovakia

Facility Name

1222.29.38003 Boehringer Ingelheim Investigational Site

City

Golnik

Country

Slovenia

Facility Name

1222.29.38002 Boehringer Ingelheim Investigational Site

City

Kamnik

Country

Slovenia

12. IPD Sharing Statement

Citations:

PubMed Identifier

26177937

Citation

Beeh KM, LaForce C, Gahlemann M, Wenz A, Toorawa R, Flezar M. Randomised, double-blind, placebo-controlled crossover study to investigate different dosing regimens of olodaterol delivered via Respimat(R) in patients with moderate to severe persistent asthma. Respir Res. 2015 Jul 16;16(1):87. doi: 10.1186/s12931-015-0243-1.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1222/1222.29_U12-1132-01-DS.pdf

Description

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A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

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A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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