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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01126437




Registration number
NCT01126437
Ethics application status
Date submitted
6/05/2010
Date registered
19/05/2010
Date last updated
20/06/2014

Titles & IDs
Public title
Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
Scientific title
A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Secondary ID [1] 0 0
2009-015713-51
Secondary ID [2] 0 0
205.452
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: Drugs - tiotropium 18 mcg
Treatment: Drugs - tiotropium 1.25 mcg (2 actuations/day)
Treatment: Drugs - tiotropium 2.5 mcg (2 actuations/day)

Experimental: tiotropium 2.5 mcg and placebo - Patients receive one of the active tiotropium arms daily

Active comparator: tiotropium 18 mcg and placebo - Patients receive one of the active tiotropium arms daily

Experimental: tiotropium 5 mcg and placebo - Patients receive one of the active tiotropium arms daily


Treatment: Drugs: tiotropium 18 mcg
HandiHaler

Treatment: Drugs: tiotropium 1.25 mcg (2 actuations/day)
soft mist inhaler 2 actuations=2 puffs/day

Treatment: Drugs: tiotropium 2.5 mcg (2 actuations/day)
soft mist inhaler (2 actuations=2 puffs/day)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to All-Cause Mortality
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Time to First COPD Exacerbation
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Number of COPD Exacerbations
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Time to First Hospitalization Associated With COPD Exacerbation
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Number of Hospitalizations Associated With COPD Exacerbation
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Time to First Moderate to Severe COPD Exacerbation
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Time to Onset of First Major Adverse Cardiovascular Event (MACE)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Time to Death From Major Adverse Cardiovascular Event (MACE)
Timepoint [7] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
Inclusion criteria:

1. All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. Male or female patients 40 years of age or older.
3. Patients must be current or ex-smokers with a smoking history of =10 pack-years. (Patients who have never smoked cigarettes must be excluded)
4. All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 = 70% of predicted normal and post-bronchodilator FEV1 / FVC =70%.

Pulmonary function tests (PFTs) were conducted after the inhalation of 400 µg salbutamol / albuterol (preferred), however testing with either 200 µg salbutamol/albuterol or a combination of salbutamol / albuterol with ipratropium bromide (2 to 4 actuations) was acceptable. Other short-acting beta agonists, such as terbutaline, may have been used for the testing. The medication used for the testing was documented. Further, historical data from measurements within the past 6 months either at the site or at a referral site may have been used (see Section 6.2.1 of the CTP, located in Appendix 16.1.1). Subjects were not to have been randomized to the study without the availability of spirometry data at the actual study site.

Eligibility for PFT sub-study: For subjects participating in the spirometry sub-study, historical data may not have been used for inclusion. These subjects must have qualified in the clinic at Visit 1 after performing a baseline measurement. These subjects performed a pre-dose PFT which was followed by the administration of 400 µg salbutamol / albuterol only (no other short-acting beta agonist was allowed), followed by a post-dose PFT for qualification.
5. Able to inhale from the HandiHaler® and the Respimat® devices.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
2. Patients with a recent history (i.e., six months or less) of myocardial infarction.
3. Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
4. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
5. Known active tuberculosis.
6. Patients with a history of asthma, cystic fibrosis, clinically evident bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
7. History of thoracotomy with pulmonary resection. Subjects with a history of thoracotomy for other reasons were to have been evaluated per exclusion criterion 1.
8. Subject was planning to undergo lung transplant or lung volume reduction surgery (LVRS).
9. Malignancy for which the subject had undergone resection, radiation, chemotherapy or biological treatments within the last 5 years. Subjects with treated basal cell carcinoma were allowed.
10. Known respiratory infection or exacerbation of COPD in the 4 weeks prior to randomization.
11. Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA), or any other components of the HandiHaler® or Respimat® inhalation solution delivery system.
12. Known moderate to severe renal impairment (as judged by the investigator).
13. Known narrow angle glaucoma.
14. Known significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms were controlled on treatment may have been included.
15. Use of systemic corticosteroid medication at unstable doses (i.e., less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day.
16. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for at least 3 months prior to and for the duration of the trial.
17. Significant alcohol or drug abuse within the past 12 months.
18. Subjects requiring the use of supplemental oxygen therapy for > 12 hours per day.
19. Subjects who had completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit or subjects who were currently in a pulmonary rehabilitation program that was not maintained throughout the duration of the study.
20. Subjects who had taken an investigational drug within 30 days prior to the Screening Visit.
21. Previous participation (receipt of randomized treatment) in this study.
22. Subjects who were currently participating in an interventional study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
17183
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
205.452.61006 Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [2] 0 0
205.452.61002 Boehringer Ingelheim Investigational Site - Woodville
Recruitment hospital [3] 0 0
205.452.61004 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [4] 0 0
205.452.61003 Boehringer Ingelheim Investigational Site - Footscray
Recruitment hospital [5] 0 0
205.452.61001 Boehringer Ingelheim Investigational Site - Frankston
Recruitment hospital [6] 0 0
205.452.61005 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Woodville
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Footscray
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
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France
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Saint Avertin
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France
State/province [195] 0 0
Saint Léger des Bois
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France
State/province [196] 0 0
Saintes
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France
State/province [197] 0 0
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France
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France
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Segre
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France
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France
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France
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St Jouan des Guerets
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France
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St Sebastien sur Loire
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France
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Strasbourg
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France
State/province [205] 0 0
Thouars
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France
State/province [206] 0 0
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France
State/province [207] 0 0
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France
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Tours
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France
State/province [209] 0 0
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France
State/province [210] 0 0
Vernoil
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France
State/province [211] 0 0
Vieux Condé
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France
State/province [212] 0 0
Vihiers
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France
State/province [213] 0 0
Villey St Etienne
Country [214] 0 0
France
State/province [214] 0 0
Wattrelos
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Georgia
State/province [215] 0 0
Tbilisi
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Germany
State/province [216] 0 0
Aschaffenburg
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Germany
State/province [217] 0 0
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Germany
State/province [218] 0 0
Backnang
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Germany
State/province [219] 0 0
Bad Kissingen
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Germany
State/province [220] 0 0
Bad Lippspringe
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Germany
State/province [221] 0 0
Bad Neustadt
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Germany
State/province [222] 0 0
Bad Wörishofen
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Germany
State/province [223] 0 0
Bamberg
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Germany
State/province [224] 0 0
Bensheim
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Germany
State/province [225] 0 0
Bergisch Gladbach
Country [226] 0 0
Germany
State/province [226] 0 0
Berlin
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Germany
State/province [227] 0 0
Bonn
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Germany
State/province [228] 0 0
Brake
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Germany
State/province [229] 0 0
Bruchsal
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Germany
State/province [230] 0 0
Celle
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Germany
State/province [231] 0 0
Cottbus
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Germany
State/province [232] 0 0
Deggendorf
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Germany
State/province [233] 0 0
Dillingen
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Germany
State/province [234] 0 0
Donaueschingen
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Germany
State/province [235] 0 0
Dortmund
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Germany
State/province [236] 0 0
Düren
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Germany
State/province [237] 0 0
Emden
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Germany
State/province [238] 0 0
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Germany
State/province [239] 0 0
Ense
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Germany
State/province [240] 0 0
Essen
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Germany
State/province [241] 0 0
Forchheim
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Germany
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Frankfurt
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Germany
State/province [243] 0 0
Fulda
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Germany
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Föhren
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Germany
State/province [245] 0 0
Gelnhausen
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Germany
State/province [246] 0 0
Gütersloh
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Germany
State/province [247] 0 0
Hagen
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Germany
State/province [248] 0 0
Hamburg
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Germany
State/province [249] 0 0
Hannover
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Germany
State/province [250] 0 0
Heidelberg
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Germany
State/province [251] 0 0
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Germany
State/province [252] 0 0
Hemmingen
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Germany
State/province [253] 0 0
Höchstädt
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Germany
State/province [254] 0 0
Ingelheim
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Germany
State/province [255] 0 0
Karlsruhe
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Germany
State/province [256] 0 0
Kassel
Country [257] 0 0
Germany
State/province [257] 0 0
Kaufbeuren
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Germany
State/province [258] 0 0
Koblenz
Country [259] 0 0
Germany
State/province [259] 0 0
Käbschütztal-Krögis
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Germany
State/province [260] 0 0
Köln
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Germany
State/province [261] 0 0
Landsberg am Lech
Country [262] 0 0
Germany
State/province [262] 0 0
Langen
Country [263] 0 0
Germany
State/province [263] 0 0
Leipzig
Country [264] 0 0
Germany
State/province [264] 0 0
Leonberg
Country [265] 0 0
Germany
State/province [265] 0 0
Mannheim
Country [266] 0 0
Germany
State/province [266] 0 0
Marburg
Country [267] 0 0
Germany
State/province [267] 0 0
Minden
Country [268] 0 0
Germany
State/province [268] 0 0
München
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Germany
State/province [269] 0 0
Neumünster
Country [270] 0 0
Germany
State/province [270] 0 0
Neuruppin
Country [271] 0 0
Germany
State/province [271] 0 0
Neuwied
Country [272] 0 0
Germany
State/province [272] 0 0
Oranienburg
Country [273] 0 0
Germany
State/province [273] 0 0
Oschersleben
Country [274] 0 0
Germany
State/province [274] 0 0
Paderborn
Country [275] 0 0
Germany
State/province [275] 0 0
Potsdam
Country [276] 0 0
Germany
State/province [276] 0 0
Radebeul
Country [277] 0 0
Germany
State/province [277] 0 0
Rathenow
Country [278] 0 0
Germany
State/province [278] 0 0
Raubach
Country [279] 0 0
Germany
State/province [279] 0 0
Rehau
Country [280] 0 0
Germany
State/province [280] 0 0
Reinfeld
Country [281] 0 0
Germany
State/province [281] 0 0
Rhaunen
Country [282] 0 0
Germany
State/province [282] 0 0
Rheine
Country [283] 0 0
Germany
State/province [283] 0 0
Rodgau-Dudenhofen
Country [284] 0 0
Germany
State/province [284] 0 0
Rüsselsheim
Country [285] 0 0
Germany
State/province [285] 0 0
Saarlouis
Country [286] 0 0
Germany
State/province [286] 0 0
Schwetzingen
Country [287] 0 0
Germany
State/province [287] 0 0
Solingen
Country [288] 0 0
Germany
State/province [288] 0 0
Tübingen
Country [289] 0 0
Germany
State/province [289] 0 0
Ulm
Country [290] 0 0
Germany
State/province [290] 0 0
Wallerfing
Country [291] 0 0
Germany
State/province [291] 0 0
Wardenburg
Country [292] 0 0
Germany
State/province [292] 0 0
Warendorf
Country [293] 0 0
Germany
State/province [293] 0 0
Weinheim
Country [294] 0 0
Germany
State/province [294] 0 0
Weyhe
Country [295] 0 0
Germany
State/province [295] 0 0
Wiesloch
Country [296] 0 0
Germany
State/province [296] 0 0
Witten
Country [297] 0 0
Germany
State/province [297] 0 0
Wolfsburg
Country [298] 0 0
Germany
State/province [298] 0 0
Zerbst
Country [299] 0 0
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State/province [299] 0 0
Athens
Country [300] 0 0
Greece
State/province [300] 0 0
Heraklion
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Greece
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Greece
State/province [302] 0 0
Kavala
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Greece
State/province [303] 0 0
Lamia
Country [304] 0 0
Greece
State/province [304] 0 0
Nafplio
Country [305] 0 0
Greece
State/province [305] 0 0
Rethymno
Country [306] 0 0
Greece
State/province [306] 0 0
Serres
Country [307] 0 0
Greece
State/province [307] 0 0
Thessaloniki
Country [308] 0 0
Guatemala
State/province [308] 0 0
Guatemala
Country [309] 0 0
Guatemala
State/province [309] 0 0
Nivel 12
Country [310] 0 0
Guatemala
State/province [310] 0 0
Nivel Guatemala
Country [311] 0 0
Guatemala
State/province [311] 0 0
Quetzaltenango
Country [312] 0 0
Hungary
State/province [312] 0 0
Baja
Country [313] 0 0
Hungary
State/province [313] 0 0
Budapest
Country [314] 0 0
Hungary
State/province [314] 0 0
Debrecen
Country [315] 0 0
Hungary
State/province [315] 0 0
Deszk
Country [316] 0 0
Hungary
State/province [316] 0 0
Dombovar
Country [317] 0 0
Hungary
State/province [317] 0 0
Erd
Country [318] 0 0
Hungary
State/province [318] 0 0
Farkasgyepü
Country [319] 0 0
Hungary
State/province [319] 0 0
Györ
Country [320] 0 0
Hungary
State/province [320] 0 0
Hajduböszörmeny
Country [321] 0 0
Hungary
State/province [321] 0 0
Hodmezovasarhely
Country [322] 0 0
Hungary
State/province [322] 0 0
Kaposvar
Country [323] 0 0
Hungary
State/province [323] 0 0
Kapuvar
Country [324] 0 0
Hungary
State/province [324] 0 0
Kecskemet
Country [325] 0 0
Hungary
State/province [325] 0 0
Makó
Country [326] 0 0
Hungary
State/province [326] 0 0
Mohacs
Country [327] 0 0
Hungary
State/province [327] 0 0
Mosonmagyarovar
Country [328] 0 0
Hungary
State/province [328] 0 0
Nagykanizsa
Country [329] 0 0
Hungary
State/province [329] 0 0
Nyiregyhaza
Country [330] 0 0
Hungary
State/province [330] 0 0
Pecs
Country [331] 0 0
Hungary
State/province [331] 0 0
Siófok
Country [332] 0 0
Hungary
State/province [332] 0 0
Szarvas
Country [333] 0 0
Hungary
State/province [333] 0 0
Szeged
Country [334] 0 0
Hungary
State/province [334] 0 0
Tatabanya
Country [335] 0 0
Hungary
State/province [335] 0 0
Törökbálint
Country [336] 0 0
India
State/province [336] 0 0
Ahmedabad
Country [337] 0 0
India
State/province [337] 0 0
Chennai
Country [338] 0 0
India
State/province [338] 0 0
Coimbatore
Country [339] 0 0
India
State/province [339] 0 0
Dadar(East)
Country [340] 0 0
India
State/province [340] 0 0
Hyderabad
Country [341] 0 0
India
State/province [341] 0 0
Jaipur
Country [342] 0 0
India
State/province [342] 0 0
Karnataka
Country [343] 0 0
India
State/province [343] 0 0
Maharashtra
Country [344] 0 0
India
State/province [344] 0 0
Maharastra
Country [345] 0 0
India
State/province [345] 0 0
Punjab
Country [346] 0 0
Ireland
State/province [346] 0 0
Co. Cork
Country [347] 0 0
Ireland
State/province [347] 0 0
Co. Tipperary
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Ireland
State/province [348] 0 0
Co. Wexford
Country [349] 0 0
Ireland
State/province [349] 0 0
Dublin 24
Country [350] 0 0
Ireland
State/province [350] 0 0
Dublin
Country [351] 0 0
Ireland
State/province [351] 0 0
Limerick
Country [352] 0 0
Ireland
State/province [352] 0 0
Offaly
Country [353] 0 0
Israel
State/province [353] 0 0
Ashkelon
Country [354] 0 0
Israel
State/province [354] 0 0
Beer Sheva
Country [355] 0 0
Israel
State/province [355] 0 0
Haifa
Country [356] 0 0
Israel
State/province [356] 0 0
Jerusalem
Country [357] 0 0
Israel
State/province [357] 0 0
Kfar Saba
Country [358] 0 0
Israel
State/province [358] 0 0
Petach Tikva
Country [359] 0 0
Israel
State/province [359] 0 0
Rehovot
Country [360] 0 0
Israel
State/province [360] 0 0
Tel-Aviv
Country [361] 0 0
Italy
State/province [361] 0 0
Arenzano (ge)
Country [362] 0 0
Italy
State/province [362] 0 0
Ascoli Piceno
Country [363] 0 0
Italy
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Avellino
Country [364] 0 0
Italy
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Benevento
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Italy
State/province [365] 0 0
Brescia
Country [366] 0 0
Italy
State/province [366] 0 0
Busto Arsizio (va)
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Italy
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Cagliari
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Italy
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Catanzaro
Country [369] 0 0
Italy
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Chieti Scalo
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Italy
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Firenze
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Italy
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Monza
Country [372] 0 0
Italy
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Napoli
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Italy
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Italy
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Palermo
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Italy
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Parma
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Italy
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Perugia
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Italy
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Prato
Country [378] 0 0
Italy
State/province [378] 0 0
Reggio Emilia
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Italy
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Roma
Country [380] 0 0
Italy
State/province [380] 0 0
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Korea, Republic of
State/province [381] 0 0
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Korea, Republic of
State/province [382] 0 0
Busan
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Korea, Republic of
State/province [383] 0 0
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Korea, Republic of
State/province [384] 0 0
Daejoen
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Korea, Republic of
State/province [385] 0 0
Gangwon-Do
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Korea, Republic of
State/province [386] 0 0
Goyang
Country [387] 0 0
Korea, Republic of
State/province [387] 0 0
Gwangju
Country [388] 0 0
Korea, Republic of
State/province [388] 0 0
Incheon
Country [389] 0 0
Korea, Republic of
State/province [389] 0 0
Jeonju
Country [390] 0 0
Korea, Republic of
State/province [390] 0 0
Seoul
Country [391] 0 0
Korea, Republic of
State/province [391] 0 0
Uijeongbu
Country [392] 0 0
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Daugavpils
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Latvia
State/province [393] 0 0
Kraslava
Country [394] 0 0
Latvia
State/province [394] 0 0
Riga
Country [395] 0 0
Latvia
State/province [395] 0 0
Talsi
Country [396] 0 0
Latvia
State/province [396] 0 0
Valmiera
Country [397] 0 0
Lithuania
State/province [397] 0 0
Alytus
Country [398] 0 0
Lithuania
State/province [398] 0 0
Kaunas
Country [399] 0 0
Lithuania
State/province [399] 0 0
Klaipeda
Country [400] 0 0
Lithuania
State/province [400] 0 0
Siauliai
Country [401] 0 0
Lithuania
State/province [401] 0 0
Utena
Country [402] 0 0
Lithuania
State/province [402] 0 0
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Johor Bahru
Country [404] 0 0
Malaysia
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Kuala Lumpur
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Malaysia
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Pahang
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Malaysia
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Malaysia
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Country [408] 0 0
Malaysia
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Mexico
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Mexico
State/province [410] 0 0
Distrito Federal
Country [411] 0 0
Mexico
State/province [411] 0 0
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Country [412] 0 0
Mexico
State/province [412] 0 0
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Country [413] 0 0
Mexico
State/province [413] 0 0
México
Country [414] 0 0
Mexico
State/province [414] 0 0
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Country [415] 0 0
Netherlands
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Almere
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Netherlands
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Andijk
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Netherlands
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Beek En Donk
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Netherlands
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Beek
Country [419] 0 0
Netherlands
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Ermelo
Country [420] 0 0
Netherlands
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Hoogwoud
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Netherlands
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Netherlands
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Oude Pekela
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Netherlands
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Roelofarendsveen
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New Zealand
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Dunedin
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New Zealand
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Newtown Wellington NZ
Country [427] 0 0
New Zealand
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Tauranga
Country [428] 0 0
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State/province [428] 0 0
Drammen
Country [429] 0 0
Norway
State/province [429] 0 0
Fredrikstad
Country [430] 0 0
Norway
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Hønefoss
Country [431] 0 0
Norway
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Kløfta
Country [432] 0 0
Norway
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Kolbjørnsvik
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Norway
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Løvenstad
Country [434] 0 0
Norway
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Oslo
Country [435] 0 0
Norway
State/province [435] 0 0
Sandvika
Country [436] 0 0
Norway
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Svelvik
Country [437] 0 0
Norway
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Trollåsen
Country [438] 0 0
Panama
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Carrasquilla
Country [439] 0 0
Panama
State/province [439] 0 0
Marbella
Country [440] 0 0
Peru
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Bellavista
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Peru
State/province [441] 0 0
Cusco
Country [442] 0 0
Peru
State/province [442] 0 0
Jesús Maria
Country [443] 0 0
Peru
State/province [443] 0 0
Jesús María
Country [444] 0 0
Peru
State/province [444] 0 0
Lima
Country [445] 0 0
Peru
State/province [445] 0 0
San Isidro
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Peru
State/province [446] 0 0
San Martin de Porres
Country [447] 0 0
Philippines
State/province [447] 0 0
Cavite City
Country [448] 0 0
Philippines
State/province [448] 0 0
Davao City
Country [449] 0 0
Philippines
State/province [449] 0 0
Iloilo City
Country [450] 0 0
Philippines
State/province [450] 0 0
Manila
Country [451] 0 0
Philippines
State/province [451] 0 0
Quezon City
Country [452] 0 0
Poland
State/province [452] 0 0
Babice
Country [453] 0 0
Poland
State/province [453] 0 0
Bialystok
Country [454] 0 0
Poland
State/province [454] 0 0
Bydgoszcz
Country [455] 0 0
Poland
State/province [455] 0 0
Checiny
Country [456] 0 0
Poland
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Gdansk
Country [457] 0 0
Poland
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Gdynia
Country [458] 0 0
Poland
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Gorzow Wlkp
Country [459] 0 0
Poland
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Ilawa
Country [460] 0 0
Poland
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Country [461] 0 0
Poland
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Krakow
Country [462] 0 0
Poland
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Libiaz
Country [463] 0 0
Poland
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Lodz
Country [464] 0 0
Poland
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Olsztyn
Country [465] 0 0
Poland
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Ostrow Wielkopolska
Country [466] 0 0
Poland
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Piaseczno
Country [467] 0 0
Poland
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Poznan
Country [468] 0 0
Poland
State/province [468] 0 0
Rokietnica
Country [469] 0 0
Poland
State/province [469] 0 0
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Country [470] 0 0
Poland
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Slawkow
Country [471] 0 0
Poland
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Szczecin
Country [472] 0 0
Poland
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Tarnow
Country [473] 0 0
Poland
State/province [473] 0 0
Tczew
Country [474] 0 0
Poland
State/province [474] 0 0
Torun
Country [475] 0 0
Poland
State/province [475] 0 0
Tranow
Country [476] 0 0
Poland
State/province [476] 0 0
Turek
Country [477] 0 0
Poland
State/province [477] 0 0
Warsaw
Country [478] 0 0
Poland
State/province [478] 0 0
Warszawa
Country [479] 0 0
Poland
State/province [479] 0 0
Wolomin
Country [480] 0 0
Poland
State/province [480] 0 0
Wroclaw
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St Just, Penzance

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
Trial website
https://clinicaltrials.gov/study/NCT01126437
Trial related presentations / publications
Wise RA, Calverley PM, Carter K, Clerisme-Beaty E, Metzdorf N, Anzueto A. Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR(R) trial. Int J Chron Obstruct Pulmon Dis. 2018 Feb 14;13:605-616. doi: 10.2147/COPD.S148393. eCollection 2018.
Calverley PMA, Mueller A, Fowler A, Metzdorf N, Wise RA. The Effect of Defining Chronic Obstructive Pulmonary Disease by the Lower Limit of Normal of FEV1/FVC Ratio in Tiotropium Safety and Performance in Respimat Participants. Ann Am Thorac Soc. 2018 Feb;15(2):200-208. doi: 10.1513/AnnalsATS.201703-194OC.
Dahl R, Calverley PM, Anzueto A, Metzdorf N, Fowler A, Mueller A, Wise R, Dusser D. Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial. BMJ Open. 2015 Dec 29;5(12):e009015. doi: 10.1136/bmjopen-2015-009015.
Anzueto A, Wise R, Calverley P, Dusser D, Tang W, Metzdorf N, Dahl R. The Tiotropium Safety and Performance in Respimat(R) (TIOSPIR(R)) Trial: Spirometry Outcomes. Respir Res. 2015 Sep 15;16(1):107. doi: 10.1186/s12931-015-0269-4.
Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, Dusser D, Joseph E, Kattenbeck S, Koenen-Bergmann M, Pledger G, Calverley P; TIOSPIR Investigators. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013 Oct 17;369(16):1491-501. doi: 10.1056/NEJMoa1303342. Epub 2013 Aug 30.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01126437