Clinical trial NCT00523991: Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Official title: A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2007-09-03
Enrollment: 457
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.


Eligibility criteria: Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio \< 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 \>50% and \< 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of \>=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score \>= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Primary outcomes:
measure: Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
timeFrame: baseline, week 24
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
timeFrame: Baseline
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
timeFrame: Baseline, week 8
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
timeFrame: Baseline, week 16
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
timeFrame: Baseline, week 24
measure: Peak Forced Expiratory Volume in 1 Second (Baseline)
timeFrame: Baseline
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
timeFrame: Baseline, week 8
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
timeFrame: Baseline, week 16
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
timeFrame: Baseline, week 24
measure: Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
timeFrame: Baseline
measure: Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
timeFrame: baseline, 30 minutes
measure: Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
timeFrame: baseline, 60 minutes
measure: Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
timeFrame: Baseline, 120 minutes
measure: Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
timeFrame: Baseline, 180 minutes
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
timeFrame: baseline, week 8, pre-dose
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
timeFrame: Baseline, week 8, 30 minutes
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
timeFrame: baseline, week 8, 60 minutes
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
timeFrame: baseline, week 8, 120 minutes
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
timeFrame: baseline, week 8, 180 minutes
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
timeFrame: baseline, week 16, pre-dose
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
timeFrame: Baseline, week 16, 30 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
timeFrame: baseline, week 16, 60 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
timeFrame: baseline, week 16, 120 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
timeFrame: baseline, week 16, 180 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
timeFrame: baseline, week 24, pre-dose
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
timeFrame: baseline, week 24, 30 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
timeFrame: baseline, week 24, 60 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
timeFrame: baseline, week 24, 120 minutes
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
timeFrame: baseline, week 24, 180 minutes
measure: FVC AUC0-3 at Baseline
timeFrame: baseline
measure: FVC AUC0-3 at Week 8 Minus Baseline
timeFrame: baseline, week 8
measure: FVC AUC0-3 at Week 16 Minus Baseline
timeFrame: baseline, week 16
measure: FVC AUC0-3 at Week 24 Minus Baseline
timeFrame: baseline, week 24
measure: Trough Forced Vital Capacity (Baseline)
timeFrame: baseline
measure: Change From Baseline in Trough Forced Vital Capacity (at Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Trough Forced Vital Capacity (at Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Trough Forced Vital Capacity (at Week 24)
timeFrame: baseline, week 24
measure: Peak Forced Vital Capacity (FVC) (Baseline)
timeFrame: baseline
measure: Change From Baseline in Peak Forced Vital Capacity (at Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Peak Forced Vital Capacity (at Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Peak Forced Vital Capacity (at Week 24)
timeFrame: baseline, week 24
measure: Forced Vital Capacity (Baseline, Pre-dose)
timeFrame: baseline
measure: Forced Vital Capacity (Baseline, 30 Minutes)
timeFrame: baseline, 30 minutes
measure: Forced Vital Capacity (Baseline, 60 Minutes)
timeFrame: baseline, 60 minutes
measure: Forced Vital Capacity (Baseline, 120 Minutes)
timeFrame: baseline, 120 minutes
measure: Forced Vital Capacity (Baseline, 180 Minutes)
timeFrame: baseline, 180 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
timeFrame: baseline, week 8, pre-dose
measure: Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
timeFrame: baseline, week 8, 30 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
timeFrame: baseline, week 8, 60 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
timeFrame: baseline, week 8, 120 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
timeFrame: baseline, week 8, 180 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
timeFrame: baseline, week 16, pre-dose
measure: Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
timeFrame: baseline, week 16, 30 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
timeFrame: baseline, week 16, 60 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
timeFrame: baseline, week 16, 120 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
timeFrame: baseline, week 16, 180 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
timeFrame: baseline, week 24, pre-dose
measure: Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
timeFrame: baseline, week 24, 30 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
timeFrame: baseline, week 24, 60 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
timeFrame: baseline, week 24, 120 minutes
measure: Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
timeFrame: baseline, week 24, 180 minutes
measure: Albuterol Use p.r.n. (Baseline)
timeFrame: baseline
measure: Change From Baseline in Albuterol Use p.r.n. - (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Albuterol Use p.r.n. - (Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Albuterol Use p.r.n. -(Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Albuterol Use p.r.n. - (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Albuterol Use p.r.n. -(Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Albuterol Use p.r.n. - (Week 24)
timeFrame: baseline, week 24
measure: Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
timeFrame: baseline
measure: Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
timeFrame: week 12
measure: Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
timeFrame: week 24
measure: Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
timeFrame: baseline
measure: Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
timeFrame: week 12
measure: Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
timeFrame: week 24
measure: Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
timeFrame: baseline
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
timeFrame: baseline, week 24
measure: Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
timeFrame: baseline
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)
timeFrame: baseline, week 24
measure: Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)
timeFrame: baseline
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)
timeFrame: baseline, week 24
measure: Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)
timeFrame: baseline
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)
timeFrame: baseline, week 24
measure: Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline
measure: Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 4
measure: Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 8
measure: Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 12
measure: Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 16
measure: Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 20
measure: Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 24
measure: Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline
measure: Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 4
measure: Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 8
measure: Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 12
measure: Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 16
measure: Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 20
measure: Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
timeFrame: baseline, week 24
measure: Number of Participants With Healthy Lifestyle (Baseline)
timeFrame: baseline
measure: Number of Participants With Healthy Lifestyle (Week 4)
timeFrame: week 4
measure: Number of Participants With Healthy Lifestyle (Week 8)
timeFrame: week 8
measure: Number of Participants With Healthy Lifestyle (Week 12)
timeFrame: week 12
measure: Number of Participants With Healthy Lifestyle (Week 16)
timeFrame: week 16
measure: Number of Participants With Healthy Lifestyle (Week 20)
timeFrame: week 20
measure: Number of Participants With Healthy Lifestyle (Week 24)
timeFrame: week 24
measure: Active Energy Expenditure (Baseline)
timeFrame: baseline
measure: Change From Baseline in Active Energy Expenditure (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Active Energy Expenditure (Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Active Energy Expenditure (Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Active Energy Expenditure (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Active Energy Expenditure (Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Active Energy Expenditure (Week 24)
timeFrame: baseline, week 24
measure: Number of Steps Per Day (Baseline)
timeFrame: baseline
measure: Change From Baseline in Number of Steps Per Day (Week 4)
timeFrame: baseline, week 4
measure: Change From Baseline in Number of Steps Per Day(Week 8)
timeFrame: baseline, week 8
measure: Change From Baseline in Number of Steps Per Day (Week 12)
timeFrame: baseline, week 12
measure: Change From Baseline in Number of Steps Per Day (Week 16)
timeFrame: baseline, week 16
measure: Change From Baseline in Number of Steps Per Day (Week 20)
timeFrame: baseline, week 20
measure: Change From Baseline in Number of Steps Per Day (Week 24)
timeFrame: baseline, week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 205.365.1003 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 205.365.1004 Boehringer Ingelheim Investigational Site
state: Alabama
city: Jasper
country: United States
facility: 205.365.1098 Boehringer Ingelheim Investigational Site
state: Alabama
city: Palo Alto
country: United States
facility: 205.365.1023 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 205.365.1125 Boehringer Ingelheim Investigational Site
state: California
city: Lexington
country: United States
facility: 205.365.1024 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: 205.365.1012 Boehringer Ingelheim Investigational Site
state: Maryland
city: Bloomington
country: United States
facility: 205.365.1086 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: 205.365.1006 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: 205.365.1085 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: 205.365.1010 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: 205.365.1007 Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: 205.365.1080 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 205.365.1118 Boehringer Ingelheim Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: 205.365.1033 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Kingsport
country: United States
facility: 205.365.1092 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Clarksburg
country: United States
facility: 205.365.1122 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Gilly
country: Belgium
facility: 205.365.1103 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 205.365.1059 Boehringer Ingelheim Investigational Site
city: Menen
country: Belgium
facility: 205.365.1057 Boehringer Ingelheim Investigational Site
city: Yvoir
country: Belgium
facility: 205.365.1058 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 205.365.1042 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Kingston
country: Canada
facility: 205.365.1056 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 205.365.1104 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ste-Foy
country: Canada
facility: 205.365.1041 Boehringer Ingelheim Investigational Site
state: Quebec
city: Cvikov
country: Czech Republic
facility: 205.365.1064 Boehringer Ingelheim Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: 205.365.1107 Boehringer Ingelheim Investigational Site
city: Karlovy Vary
country: Czech Republic
facility: 205.365.1061 Boehringer Ingelheim Investigational Site
city: Liberec
country: Czech Republic
facility: 205.365.1077 Boehringer Ingelheim Investigational Site
city: Neratovice
country: Czech Republic
facility: 205.365.1079 Boehringer Ingelheim Investigational Site
city: Pardubice
country: Czech Republic
facility: 205.365.1116 Boehringer Ingelheim Investigational Site
city: Praha 10
country: Czech Republic
facility: 205.365.1062 Boehringer Ingelheim Investigational Site
city: Praha 3
country: Czech Republic
facility: 205.365.1083 Boehringer Ingelheim Investigational Site
city: Praha 6
country: Czech Republic
facility: 205.365.1117 Boehringer Ingelheim Investigational Site
city: Strakonice
country: Czech Republic
facility: 205.365.1075 Boehringer Ingelheim Investigational Site
city: Tabor
country: Czech Republic
facility: 205.365.1063 Boehringer Ingelheim Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: 205.365.1076 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 205.365.1055 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 205.365.1066 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 205.365.1054 Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: 205.365.1052 Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: 205.365.1050 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.365.1067 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 205.365.1127 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 205.365.1126 Boehringer Ingelheim Investigational Site
city: Enschede
country: Netherlands
facility: 205.365.1070 Boehringer Ingelheim Investigational Site
city: Etten Leur
country: Netherlands
facility: 205.365.1072 Boehringer Ingelheim Investigational Site
city: Spijkenisse
country: Netherlands
facility: 205.365.1071 Boehringer Ingelheim Investigational Site
city: Zutphen
country: Netherlands
facility: 205.365.1069 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 205.365.1025 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 205.365.1020 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 205.365.1022 Boehringer Ingelheim Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: 205.365.1128 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 205.365.1110 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 205.365.1108 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 205.365.1112 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 205.365.1114 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 205.365.1115 Boehringer Ingelheim Investigational Site
city: Simferopol
country: Ukraine
facility: 205.365.1113 Boehringer Ingelheim Investigational Site
city: Garston, Watford
country: United Kingdom
facility: 205.365.44002 Boehringer Ingelheim Investigational Site
city: Harrow
country: United Kingdom
facility: 205.365.44003 Boehringer Ingelheim Investigational Site
city: Warminster
country: United Kingdom
facility: 205.365.44004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3.