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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
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
Timepoint [1] 0 0
Baseline and Day 337
Primary outcome [2] 0 0
Time to First Chronic Obstructive Pulmonary Disease (COPD) 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
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
Timepoint [2] 0 0
Baseline and Day 169
Secondary outcome [3] 0 0
Number of COPD Exacerbations Per Patient - Exposure Adjusted
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
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
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
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
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
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
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
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
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
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
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
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
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
Timepoint [16] 0 0
Baseline and Day 337
Secondary outcome [17] 0 0
Marked Changes From Baseline in Vital Signs at End of Treatment
Timepoint [17] 0 0
Baseline and end of treatment
Secondary outcome [18] 0 0
Clinically Relevant Findings in Physical Examination and ECG
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
Sex
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
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
3991
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
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- Redcliffe
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- Port Lincoln
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- 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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Turkey
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Bursa
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Turkey
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Edirne
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Turkey
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Istanbul
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Izmir
Country [209] 0 0
Turkey
State/province [209] 0 0
Kayseri
Country [210] 0 0
Turkey
State/province [210] 0 0
Konya
Country [211] 0 0
Turkey
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Samsun
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Aston Clinton, Aylesbury
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Carmarthen
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Chertsey
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Chesterfield
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Darlington
Country [217] 0 0
United Kingdom
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East Horsley
Country [218] 0 0
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Fowey
Country [219] 0 0
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Frome
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Greenisland
Country [221] 0 0
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Heywood
Country [222] 0 0
United Kingdom
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Isleworth
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Kirkby in Ashfield
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Mortimer
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Nottingham
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Penzance
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Plymouth
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Sheffield
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Sneinton, Nottingham
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St Just, Penzance
Country [231] 0 0
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State/province [231] 0 0
St. Austell
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Sunderland
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Wellingborough
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Westbury on Trym
Country [235] 0 0
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Windsor
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State/province [236] 0 0
Woking

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/study/NCT00387088
Trial related presentations / publications
Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.
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/NCT00387088