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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00528996
Other study ID # 1205.14
Secondary ID 2007-007946-42
Status Completed
Phase Phase 2
First received
Last updated
Start date September 6, 2007
Est. completion date May 5, 2009

Study information

Verified date July 2021
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2080
Est. completion date May 5, 2009
Est. primary completion date May 5, 2009
Accepts healthy volunteers No
Gender All
Age group 40 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
BEA 2180 BR
Solution
Tiotropium Bromide
Solution
Placebo
Solution

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hungary,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks 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 Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks 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.
Secondary Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks 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.
Secondary 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 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.
Secondary Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks 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.
Secondary Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks 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.
Secondary Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks 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.
Secondary Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point 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.
Secondary Individual Forced Vital Capacity (FVC) Measurements at Each Time Point 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.
Secondary Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5 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.
Secondary Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration 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.
Secondary Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration 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.
Secondary Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) 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.
Secondary Weekly Mean Evening Peak Expiratory Flow Rate (PEFR) 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.
Secondary Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol]) 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.
Secondary Physician's Global Evaluation 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.
Secondary Transition Dyspnea Index - Functional Impairment Domain Score 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.
Secondary Transition Dyspnea Index - Magnitude of Task Domain Score 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
Secondary Transition Dyspnea Index - Magnitude of Effort Domain Score 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
Secondary St. George's Respiratory Questionnaire (SGRQ) Total Score 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.
Secondary 36-item-health Survey (SF-36) 8 Domain Scores at Baseline 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).
Secondary 36-item-health Survey (SF-36) - Physical Function Domain Score 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.
Secondary 36-item-health Survey (SF-36) - Role Physical Domain Score 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.
Secondary 36-item-health Survey (SF-36) - Bodily Pain Domain Score 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.
Secondary 36-item-health Survey (SF-36) - General Physical Health Domain Score 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.
Secondary 36-item-health Survey (SF-36) - Vitality Domain Score 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.
Secondary 36-item-health Survey (SF-36) - Social Functioning Domain Score 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.
Secondary 36-item-health Survey (SF-36) - Role Emotional Domain Score 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.
Secondary 36-item-health Survey (SF-36) - General Mental Health Domain Score 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.
Secondary Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation 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.
Secondary Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation 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.
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