An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

July 30, 2021 updated by: Boehringer Ingelheim

A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2080

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • 1205.14.146 Boehringer Ingelheim Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada
        • 1205.14.151 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1205.14.144 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 1205.14.148 Boehringer Ingelheim Investigational Site
    • Ontario
      • Burlington, Ontario, Canada
        • 1205.14.143 Boehringer Ingelheim Investigational Site
      • Downsview, Ontario, Canada
        • 1205.14.142 Boehringer Ingelheim Investigational Site
      • Grimsby, Ontario, Canada
        • 1205.14.150 Boehringer Ingelheim Investigational Site
      • Mississauga, Ontario, Canada
        • 1205.14.149 Boehringer Ingelheim Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada
        • 1205.14.145 Boehringer Ingelheim Investigational Site
  • Germany
      • Aschaffenburg, Germany
        • 1205.14.381 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.164 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.167 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.168 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.172 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.175 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.177 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.178 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.377 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.382 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.387 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1205.14.388 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 1205.14.165 Boehringer Ingelheim Investigational Site
      • Cottbus, Germany
        • 1205.14.176 Boehringer Ingelheim Investigational Site
      • Dortmund, Germany
        • 1205.14.171 Boehringer Ingelheim Investigational Site
      • Geesthacht, Germany
        • 1205.14.379 Boehringer Ingelheim Investigational Site
      • Gelnhausen, Germany
        • 1205.14.174 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1205.14.173 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1205.14.375 Boehringer Ingelheim Investigational Site
      • Koblenz, Germany
        • 1205.14.378 Boehringer Ingelheim Investigational Site
      • Lübeck, Germany
        • 1205.14.170 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1205.14.162 Boehringer Ingelheim Investigational Site
      • Marburg, Germany
        • 1205.14.384 Boehringer Ingelheim Investigational Site
      • Minden, Germany
        • 1205.14.166 Boehringer Ingelheim Investigational Site
      • Neumünster, Germany
        • 1205.14.372 Boehringer Ingelheim Investigational Site
      • Neuruppin, Germany
        • 1205.14.386 Boehringer Ingelheim Investigational Site
      • Oschersleben, Germany
        • 1205.14.385 Boehringer Ingelheim Investigational Site
      • Rüdersdorf, Germany
        • 1205.14.169 Boehringer Ingelheim Investigational Site
      • Rüsselsheim, Germany
        • 1205.14.179 Boehringer Ingelheim Investigational Site
      • Saarbrücken, Germany
        • 1205.14.376 Boehringer Ingelheim Investigational Site
      • Schwetzingen, Germany
        • 1205.14.374 Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • 1205.14.371 Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • 1205.14.373 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budakeszi, Hungary
        • 1205.14.279 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1205.14.273 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1205.14.283 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1205.14.287 Boehringer Ingelheim Investigational Site
      • Cegled, Hungary
        • 1205.14.286 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 1205.14.281 Boehringer Ingelheim Investigational Site
      • Deszk, Hungary
        • 1205.14.272 Boehringer Ingelheim Investigational Site
      • Deszk, Hungary
        • 1205.14.289 Boehringer Ingelheim Investigational Site
      • Erd, Hungary
        • 1205.14.271 Boehringer Ingelheim Investigational Site
      • Gyula, Hungary
        • 1205.14.282 Boehringer Ingelheim Investigational Site
      • Gödöllö, Hungary
        • 1205.14.276 Boehringer Ingelheim Investigational Site
      • Komarom, Hungary
        • 1205.14.277 Boehringer Ingelheim Investigational Site
      • Matrahaza, Hungary
        • 1205.14.278 Boehringer Ingelheim Investigational Site
      • Mosonmagyarovar, Hungary
        • 1205.14.280 Boehringer Ingelheim Investigational Site
      • Sopron, Hungary
        • 1205.14.285 Boehringer Ingelheim Investigational Site
      • Szarvas, Hungary
        • 1205.14.275 Boehringer Ingelheim Investigational Site
      • Szazhalombatta, Hungary
        • 1205.14.288 Boehringer Ingelheim Investigational Site
      • Tatabanya, Hungary
        • 1205.14.284 Boehringer Ingelheim Investigational Site
      • Zalaegerszeg, Hungary
        • 1205.14.274 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • 1205.14.225 Boehringer Ingelheim Investigational Site
      • Gyeonggi-do, Korea, Republic of
        • 1205.14.228 Boehringer Ingelheim Investigational Site
      • Seongdong-gu, Korea, Republic of
        • 1205.14.227 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1205.14.221 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1205.14.222 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1205.14.223 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1205.14.224 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1205.14.226 Boehringer Ingelheim Investigational Site
  • Mexico
      • Ciudad de Mexico, Mexico
        • 1205.14.117 Boehringer Ingelheim Investigational Site
      • Cuernavaca, Mor. México, Mexico
        • 1205.14.108 Boehringer Ingelheim Investigational Site
      • Hermosillo, Sonora, Mexico
        • 1205.14.101 Boehringer Ingelheim Investigational Site
      • Metepec, Mexico
        • 1205.14.119 Boehringer Ingelheim Investigational Site
      • Mexico City, Mexico
        • 1205.14.120 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1205.14.102 Boehringer Ingelheim Investigational Site
      • Monterrey, Nuevo León, Mexico
        • 1205.14.116 Boehringer Ingelheim Investigational Site
      • Zapopan, Jal., Mexico
        • 1205.14.105 Boehringer Ingelheim Investigational Site
  • Poland
      • Chrzanow, Poland
        • 1205.14.251 Boehringer Ingelheim Investigational Site
      • Gdansk, Poland
        • 1205.14.253 Boehringer Ingelheim Investigational Site
      • Gdansk, Poland
        • 1205.14.254 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1205.14.246 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 1205.14.241 Boehringer Ingelheim Investigational Site
      • Lodz, Poland
        • 1205.14.242 Boehringer Ingelheim Investigational Site
      • Miechow, Poland
        • 1205.14.255 Boehringer Ingelheim Investigational Site
      • Ruda Slaska, Poland
        • 1205.14.248 Boehringer Ingelheim Investigational Site
      • Tarnowskie Gory, Poland
        • 1205.14.249 Boehringer Ingelheim Investigational Site
      • Wilkowice, Poland
        • 1205.14.252 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 1205.14.243 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 1205.14.244 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 1205.14.245 Boehringer Ingelheim Investigational Site
      • Zabrze, Poland
        • 1205.14.247 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1205.14.301 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1205.14.302 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1205.14.303 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1205.14.304 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1205.14.305 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1205.14.306 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1205.14.310 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1205.14.311 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1205.14.312 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1205.14.313 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1205.14.314 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1205.14.307 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1205.14.308 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1205.14.309 Boehringer Ingelheim Investigational Site
  • Spain
      • Badajoz, Spain
        • 1205.14.182 Boehringer Ingelheim Investigational Site
      • Cáceres, Spain
        • 1205.14.186 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1205.14.183 Boehringer Ingelheim Investigational Site
      • Málaga, Spain
        • 1205.14.191 Boehringer Ingelheim Investigational Site
      • Terrassa (Barcelona), Spain
        • 1205.14.181 Boehringer Ingelheim Investigational Site
      • Torrevieja, Spain
        • 1205.14.190 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1205.14.189 Boehringer Ingelheim Investigational Site
      • Vigo, Spain
        • 1205.14.187 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Changhua, Taiwan
        • 1205.14.207 Boehringer Ingelheim Investigational Site
      • Chiayi City, Taiwan
        • 1205.14.208 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1205.14.210 Boehringer Ingelheim Investigational Site
      • Kaohsiung County, Taiwan
        • 1205.14.209 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1205.14.205 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1205.14.206 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1205.14.202 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1205.14.204 Boehringer Ingelheim Investigational Site
      • Taoyuan County, Taiwan
        • 1205.14.201 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Jasper, Alabama, United States
        • 1205.14.061 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 1205.14.054 Boehringer Ingelheim Investigational Site
    • California
      • Berkeley, California, United States
        • 1205.14.042 Boehringer Ingelheim Investigational Site
      • La Jolla, California, United States
        • 1205.14.017 Boehringer Ingelheim Investigational Site
      • Lakewood, California, United States
        • 1205.14.022 Boehringer Ingelheim Investigational Site
      • Riverside, California, United States
        • 1205.14.046 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1205.14.008 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1205.14.047 Boehringer Ingelheim Investigational Site
      • Sepulveda, California, United States
        • 1205.14.037 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 1205.14.041 Boehringer Ingelheim Investigational Site
      • Fort Collins, Colorado, United States
        • 1205.14.027 Boehringer Ingelheim Investigational Site
      • Wheat Ridge, Colorado, United States
        • 1205.14.034 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Stamford, Connecticut, United States
        • 1205.14.050 Boehringer Ingelheim Investigational Site
    • Florida
      • Bay Pines, Florida, United States
        • 1205.14.013 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • 1205.14.016 Boehringer Ingelheim Investigational Site
      • DeLand, Florida, United States
        • 1205.14.048 Boehringer Ingelheim Investigational Site
      • Panama City, Florida, United States
        • 1205.14.043 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1205.14.040 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 1205.14.007 Boehringer Ingelheim Investigational Site
      • Stockbridge, Georgia, United States
        • 1205.14.053 Boehringer Ingelheim Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • 1205.14.014 Boehringer Ingelheim Investigational Site
    • Kansas
      • Olathe, Kansas, United States
        • 1205.14.035 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • 1205.14.057 Boehringer Ingelheim Investigational Site
      • Shreveport, Louisiana, United States
        • 1205.14.052 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • 1205.14.036 Boehringer Ingelheim Investigational Site
      • Livonia, Michigan, United States
        • 1205.14.019 Boehringer Ingelheim Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States
        • 1205.14.018 Boehringer Ingelheim Investigational Site
      • Saint Louis, Missouri, United States
        • 1205.14.032 Boehringer Ingelheim Investigational Site
    • Nevada
      • Reno, Nevada, United States
        • 1205.14.033 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Brick, New Jersey, United States
        • 1205.14.044 Boehringer Ingelheim Investigational Site
      • Cherry Hill, New Jersey, United States
        • 1205.14.056 Boehringer Ingelheim Investigational Site
      • Summit, New Jersey, United States
        • 1205.14.058 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 1205.14.010 Boehringer Ingelheim Investigational Site
    • New York
      • Larchmont, New York, United States
        • 1205.14.062 Boehringer Ingelheim Investigational Site
      • Mineola, New York, United States
        • 1205.14.028 Boehringer Ingelheim Investigational Site
      • New Hyde Park, New York, United States
        • 1205.14.030 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1205.14.021 Boehringer Ingelheim Investigational Site
    • Ohio
      • Toledo, Ohio, United States
        • 1205.14.059 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1205.14.012 Boehringer Ingelheim Investigational Site
    • Oregon
      • Medford, Oregon, United States
        • 1205.14.031 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1205.14.003 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 1205.14.004 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Johnston, Rhode Island, United States
        • 1205.14.005 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • 1205.14.029 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, United States
        • 1205.14.055 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • 1205.14.020 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, United States
        • 1205.14.045 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1205.14.025 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, United States
        • 1205.14.060 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1205.14.002 Boehringer Ingelheim Investigational Site
    • Virginia
      • Richmond, Virginia, United States
        • 1205.14.023 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 1205.14.024 Boehringer Ingelheim Investigational Site
      • Roanoke, Virginia, United States
        • 1205.14.026 Boehringer Ingelheim Investigational Site
    • Washington
      • Spokane, Washington, United States
        • 1205.14.009 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 1205.14.039 Boehringer Ingelheim Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • 1205.14.001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.

  2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:

    Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).

  3. Male or female patients 40 years of age or older.
  4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
  5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
  6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

Exclusion Criteria:

  1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
  2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
  3. Patients with a recent history (one year or less) of myocardial infarction.
  4. Patients with any unstable or life-threatening cardiac arrhythmia.
  5. Patients who have been hospitalized for heart failure within the past 3 years.
  6. Patients with a 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.
  7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
  8. Patients with known narrow-angle glaucoma.
  9. Patients with asthma or a history of asthma.
  10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
  11. Patients with known active tuberculosis.
  12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Solution
Experimental: BEA 2180 BR low dose
Low dose
Drug: BEA 2180 BR
Solution
Experimental: BEA 2180 BR medium dose
Medium dose
Drug: BEA 2180 BR
Solution
Experimental: BEA 2180 BR high dose
High dose
Drug: BEA 2180 BR
Solution
Experimental: Tiotropium Bromide
Drug: Tiotropium Bromide
Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.
Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.
40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.
Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.
40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.
Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.
Trough forced vital capacity (FVC) response was defined as the change from baseline in trough FVC. Trough FVC was defined as the mean of the two FVC measurements recorded at the pre-dose measurements (40 and 15 minutes before drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler), which were obtained through spirometry at the same time points as for forced expiratory volume in one second. Baseline FVC was the mean of the two measurements of FVC taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.
40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced expiratory volume in one second (FEV1) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FEV1 AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FEV1. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.
40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced vital capacity (FVC) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FVC AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FVC. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.
40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced expiratory volume in one second (FEV1) peak response after 0, 4, 12, and 24 weeks were reported. Peak FEV1 response was the maximum change from baseline for the post-dose measurements of FEV1. Baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration.
40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks
Time Frame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Forced Vital Capacity (FVC) peak response after 0, 4, 12, and 24 weeks were reported. Peak FVC response was the maximum change from baseline for the post-dose measurements of FVC. Baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration.
40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point
Time Frame: 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
Individual Forced expiratory volume in one second (FEV1) values measured at each time points at Week 0, 4, 12, and 24 were reported.
15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
Individual Forced Vital Capacity (FVC) Measurements at Each Time Point
Time Frame: 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
Individual Forced Vital Capacity (FVC) values measured at each time point at Week 0, 4, 12, and 24 were reported.
15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5
Time Frame: 40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period.
Trough Forced expiratory volume in one second (FEV1) response on Day 3 and 5 are reported, for which the FEV1 response is the change from baseline in trough FEV1. Trough FEV1 for respective day (Day 3 or Day 5)was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler) at that day. Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.
40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period.
Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration
Time Frame: 3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
Forced expiratory volume in one second (FEV1) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.
3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration
Time Frame: 3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
Forced Vital Capacity (FVC) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.
3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR)
Time Frame: Assessed before drug administration per day during 24 weeks with weekly mean values reporting.
The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean morning peak expiratory flow rate (PEFR) is reported.
Assessed before drug administration per day during 24 weeks with weekly mean values reporting.
Weekly Mean Evening Peak Expiratory Flow Rate (PEFR)
Time Frame: Assessed at bed time per day during 24 weeks with weekly mean values reporting.
The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean of evening peak expiratory flow rate (PEFR) is reported.
Assessed at bed time per day during 24 weeks with weekly mean values reporting.
Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol])
Time Frame: Assessed once per day during 24 weeks with weekly mean values reporting.
The patient recorded the number of occasions salbutamol (albuterol) Metered Dose Inhaler (MDI) was used each day and night during the entire evaluation period. The weekly mean number of occasions of rescue therapy used per day (PRN salbutamol [albuterol]) is reported.
Assessed once per day during 24 weeks with weekly mean values reporting.
Physician's Global Evaluation
Time Frame: At Week 0, 4, 12, and 24.
Physicians make a global evaluation reflecting the physician's global opinion of the overall clinical condition of the patient as "poor" (score 1 or 2), "fair" (score 3 or 4), "good" (score 5 or 6), or "excellent" (score 7 or 8). These assessments are made prior to pulmonary function testing and are summarized on pulmonary function test days. This evaluation was based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations. The score ranges from 1 to 8 with higher score indicating better overall clinical condition.
At Week 0, 4, 12, and 24.
Transition Dyspnea Index - Functional Impairment Domain Score
Time Frame: At Week 0 (baseline), 4, 12 and 24.
The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of functional impairment is reported, which domain score ranges from -3 (major deterioration in the ability of working and doing activities due to shortness of breath; the worst score) to 3 (major improvement in the ability of working and doing activities; mild restriction on full activities due to the improvement of shortness of breath; the best score).
At Week 0 (baseline), 4, 12 and 24.
Transition Dyspnea Index - Magnitude of Task Domain Score
Time Frame: At week 0 (baseline), 4, 12 and 24
The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of task is reported, which domain score ranges from -3 (major deterioration from baseline status; the worst score) to 3 (major improvement from baseline status; the best score).
At week 0 (baseline), 4, 12 and 24
Transition Dyspnea Index - Magnitude of Effort Domain Score
Time Frame: At Week 0 (baseline), 4, 12 and 24
The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of effort is reported, which sub-score ranges from -3 (severe decrease in effort from baseline to avoid shortness of breath. Activities now take 50-100% longer to complete than required at baseline; the worst score) to 3 (Able to do things with much greater effort than previously with few pauses. Activities may be performed 50- 100% more rapidly than at baseline; the best score).
At Week 0 (baseline), 4, 12 and 24
St. George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: At Week 0, 4, 12, and 24.
The St. George's Respiratory Questionnaire (SGRQ) is a well-established, self-completed tool measuring health-related quality of life in patients with diseases of airways obstruction on three aspects of symptoms, activity, and impacts. The total SGRQ score is reported, which ranges from 0 (the best score) to 100 (the worst score) with smaller score value indicating less limitations due to breathlessness and better quality of life.
At Week 0, 4, 12, and 24.
36-item-health Survey (SF-36) 8 Domain Scores at Baseline
Time Frame: At baseline (Week 0, Day 1 of treatment period).
The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function (10 questions), role physical (4 questions), Bodily pain (2 questions), General physical health (5 questions), Vitality (4 questions), Social functioning (2 questions), role emotional (3 questions), and General mental health (5 questions). Each domain score is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the score value, the better the health condition.
At baseline (Week 0, Day 1 of treatment period).
36-item-health Survey (SF-36) - Physical Function Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of physical function (based on 10 questions) is reported, which is the weighted sum of the questions in corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical function.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - Role Physical Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of role limitations due to physical health problems (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitations in roles due to physical health problems.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - Bodily Pain Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of bodily pain (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less severer the bodily pain.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - General Physical Health Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of general physical health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical health in general.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - Vitality Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of vitality (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the more vitality and less fatigue one has.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - Social Functioning Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of Social functioning (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the social functioning.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - Role Emotional Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of role emotional (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitation in roles due to emotional problems.
At Week 4, 12, and 24.
36-item-health Survey (SF-36) - General Mental Health Domain Score
Time Frame: At Week 4, 12, and 24.

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health.

The domain score of general mental health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the mental health in general.
At Week 4, 12, and 24.
Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time Frame: From first does until 30 days after the end of treatment, up to 205 days.
Number of patients with at least one Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as "a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment", where a "complex of lower respiratory events / symptoms" means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness.
From first does until 30 days after the end of treatment, up to 205 days.
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time Frame: From first does until 30 days after the end of treatment, up to 205 days.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as "a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment", where a "complex of lower respiratory events / symptoms" means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness.
From first does until 30 days after the end of treatment, up to 205 days.

Collaborators and Investigators

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Sponsor

Boehringer Ingelheim

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2007

Primary Completion (Actual)

May 5, 2009

Study Completion (Actual)

May 5, 2009

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

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Terms related to this study

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Other Study ID Numbers

  • 1205.14
  • 2007-007946-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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