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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00387088




Registration number
NCT00387088
Ethics application status
Date submitted
11/10/2006
Date registered
12/10/2006
Date last updated
16/05/2014

Titles & IDs
Public title
Tiotropium / Respimat One Year Study in COPD.
Scientific title
Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
Secondary ID [1] 0 0
2006-001009-27
Secondary ID [2] 0 0
205.372
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Respimat
Treatment: Drugs - Tiotropium

Other: Tiotropium - Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Other: Placebo - Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)


Treatment: Devices: Respimat


Treatment: Drugs: Tiotropium


Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 - Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Timepoint [1] 0 0
Baseline and Day 337
Primary outcome [2] 0 0
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
Timepoint [2] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 - Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Timepoint [1] 0 0
Baseline and Day 29
Secondary outcome [2] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 - Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Timepoint [2] 0 0
Baseline and Day 169
Secondary outcome [3] 0 0
Number of COPD Exacerbations Per Patient - Exposure Adjusted - Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Timepoint [3] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [4] 0 0
Number of COPD Exacerbations Per Patient - naïve Estimate - Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Timepoint [4] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [5] 0 0
Number of Patients With at Least One COPD Exacerbation - Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Timepoint [5] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [6] 0 0
Time to First Hospitalisation for COPD Exacerbation - Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
Timepoint [6] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [7] 0 0
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted - Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Timepoint [7] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [8] 0 0
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate - Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Timepoint [8] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [9] 0 0
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation - Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Timepoint [9] 0 0
During actual study treatment period (planned Day 1 to Day 337)
Secondary outcome [10] 0 0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 - The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Timepoint [10] 0 0
Baseline and Day 337
Secondary outcome [11] 0 0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 - The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Timepoint [11] 0 0
Baseline and Day 169
Secondary outcome [12] 0 0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 - The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Timepoint [12] 0 0
Baseline and Day 337
Secondary outcome [13] 0 0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 - The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Timepoint [13] 0 0
Baseline and Day 169
Secondary outcome [14] 0 0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 - Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Timepoint [14] 0 0
Baseline and Day 29
Secondary outcome [15] 0 0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 - Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Timepoint [15] 0 0
Baseline and Day 169
Secondary outcome [16] 0 0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 - Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Timepoint [16] 0 0
Baseline and Day 337
Secondary outcome [17] 0 0
Marked Changes From Baseline in Vital Signs at End of Treatment - Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.
SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.
DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.
PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.
Timepoint [17] 0 0
Baseline and end of treatment
Secondary outcome [18] 0 0
Clinically Relevant Findings in Physical Examination and ECG - Clinically relevant findings in Physical Examination and ECG at end of treatment
Timepoint [18] 0 0
End of treatment

Eligibility
Key inclusion criteria
1. Male or female

2. At least 40 years old

3. Smoker or ex-smoker

4. Smoking history > 10 pack-years

5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or
hospitalisation for cardiac failure

2. History of asthma or allergic conditions.

3. Malignancy requiring treatment within past 5 years

4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident
bronchiectasis

5. Known active tuberculosis

6. Known hypersensitivity to anticholinergic drugs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
205.372.61002 Woolcock Institute of Medical Research - Glebe
Recruitment hospital [2] 0 0
205.372.61009 Thoracic & General Physician - Cairns
Recruitment hospital [3] 0 0
205.372.61005 Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 0 0
205.372.61006 The Investigator Clinic - Port Lincoln
Recruitment hospital [5] 0 0
205.372.61007 The Burnside War Memorial Hospital - Toorak Gardens
Recruitment hospital [6] 0 0
205.372.61004 Boehringer Ingelheim Investigational Site - Woodville
Recruitment hospital [7] 0 0
205.372.61010 Ecru - Box Hill
Recruitment hospital [8] 0 0
205.372.61008 Geelong Clinical Research Centre - Geelong
Recruitment hospital [9] 0 0
205.372.61001 Emeritus Research - Malvern
Recruitment hospital [10] 0 0
205.372.61003 Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Glebe
Recruitment postcode(s) [2] 0 0
- Cairns
Recruitment postcode(s) [3] 0 0
- Redcliffe
Recruitment postcode(s) [4] 0 0
- Port Lincoln
Recruitment postcode(s) [5] 0 0
- Toorak Gardens
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment postcode(s) [9] 0 0
- Malvern
Recruitment postcode(s) [10] 0 0
- Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Iowa
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Kansas
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Louisiana
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Maine
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Maryland
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Michigan
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Missouri
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Nebraska
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North Carolina
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Virginia
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Washington
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Brazil
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Florianópolis
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Goiânia
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Brazil
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Recife
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Brazil
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São Paulo - SP
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Brazil
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Vitória
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Alberta
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New Brunswick
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Nîmes
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Ollioules
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Reims
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Saint Laurent du Var
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Six Four les Plages
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Germany
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Bonn
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Germany
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Bruchsal
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Germany
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Frankfurt/Main
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Gütersloh
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Hannover
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Kassel
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Minden
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München
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Weinheim
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Weyhe
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Wiesloch
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Witten
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Greece
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Athens
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Heraklion-Crete
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Serres
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Erd
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Mosonmagyarovar
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Sopron
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India
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India
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Coimbatore
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India
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indore,MP
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Mumbai
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India
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New Delhi
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Punjab
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India
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Tamil Nadu
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India
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Uttar Pradesh
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Ireland
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Mullingar
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Italy
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Bussolengo (vr)
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Orbassano (to)
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Italy
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Pisa
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Italy
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Pordenone
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Italy
State/province [129] 0 0
Prato (fi)
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Italy
State/province [130] 0 0
Roma
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Italy
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Trieste
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Korea, Republic of
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Anyang
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejoen
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonbuk
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Korea, Republic of
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Kwangju
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Johor Baharu
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Malaysia
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Kelantan Darul Naim
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching, Sarawak
Country [146] 0 0
Malaysia
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Penang
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Malaysia
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Selangor
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Mexico
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Chihuahua
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Mexico
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Col. Seccion XVI
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Mexico
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Cuernavaca, Mor. México
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Mexico
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Guadalajara Jal.
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Mexico
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Guadalajara
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Mexico
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Hermosillo, Sonora
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Mexico
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Huixquilucan Edo.Mex.
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Merida Yuc.
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Mexicali Baja California Norte
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Mexico
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Monterrey, Nuevo León
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Mérida Yucatán
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Mexico
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San Luis Potosi
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Mexico
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Zapopan, Jal.
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Netherlands
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Amsterdam
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Drachten
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Groningen
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Hoofddorp
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Leeuwarden
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Roosendaal
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Sneek
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Utrecht
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Voorburg
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Weerselo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the study is to evaluate the long-term (one year) efficacy and safety of
tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study
will examine the effect of treatment on COPD exacerbations.
Trial website
https://clinicaltrials.gov/show/NCT00387088
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications