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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00975195




Registration number
NCT00975195
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009
Date last updated
10/02/2015

Titles & IDs
Public title
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Scientific title
A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Secondary ID [1] 0 0
2007-002522-29
Secondary ID [2] 0 0
352.2046
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
Experimental: fluticasone high dose - fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate

Experimental: fluticasone medium & low doses - fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Moderate or Severe On-treatment COPD Exacerbation
Timepoint [1] 0 0
During randomised treatment, up to 488 days
Secondary outcome [1] 0 0
Number of Moderate or Severe On-treatment COPD Exacerbations
Timepoint [1] 0 0
During randomised treatment, up to 488 days
Secondary outcome [2] 0 0
Proportion of Patients With =1 Moderate or Severe On-treatment COPD Exacerbation
Timepoint [2] 0 0
During randomised treatment, up to 488 days
Secondary outcome [3] 0 0
Time to First Severe On-treatment COPD Exacerbation
Timepoint [3] 0 0
During randomised treatment, up to 488 days
Secondary outcome [4] 0 0
Number of Severe On-treatment COPD Exacerbations
Timepoint [4] 0 0
During randomised treatment, up to 488 days
Secondary outcome [5] 0 0
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
Timepoint [5] 0 0
During randomised treatment, up to 488 days
Secondary outcome [6] 0 0
Time to First On-treatment COPD Exacerbation
Timepoint [6] 0 0
During randomised treatment, up to 488 days
Secondary outcome [7] 0 0
Number of On-treatment COPD Exacerbations
Timepoint [7] 0 0
During randomised treatment, up to 488 days
Secondary outcome [8] 0 0
Proportion of Patients With at Least One On-treatment COPD Exacerbation
Timepoint [8] 0 0
During randomised treatment, up to 488 days
Secondary outcome [9] 0 0
Severity of On-treatment COPD Exacerbations
Timepoint [9] 0 0
During randomised treatment, up to 488 days
Secondary outcome [10] 0 0
Change in On-treatment Lung Function as Measured by Trough FEV1
Timepoint [10] 0 0
Baseline and week 6, 12, 18 and 52 visits
Secondary outcome [11] 0 0
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Timepoint [11] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [12] 0 0
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Timepoint [12] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [13] 0 0
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Timepoint [13] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [14] 0 0
Change in On-treatment BODE Index
Timepoint [14] 0 0
Baseline and week 18 and 52 visits
Secondary outcome [15] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Timepoint [15] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [16] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Timepoint [16] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [17] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Timepoint [17] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [18] 0 0
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Timepoint [18] 0 0
Baseline and week 12, 18 and 52 visits
Secondary outcome [19] 0 0
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Timepoint [19] 0 0
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Secondary outcome [20] 0 0
Change in On-treatment FVC as Measured by Home Based Spirometry
Timepoint [20] 0 0
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Secondary outcome [21] 0 0
Change in On-treatment PEFR as Measured by Home Based Spirometry
Timepoint [21] 0 0
Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
Secondary outcome [22] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Timepoint [22] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [23] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Timepoint [23] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [24] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Timepoint [24] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [25] 0 0
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Timepoint [25] 0 0
Baseline and week 27 and 52 visits
Secondary outcome [26] 0 0
Change in On-treatment Physician Global Evaluation
Timepoint [26] 0 0
Baseline and week 27 and 52 visits

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male or female aged 40 years or more
2. Severe to very severe chronic obstructive pulmonary disease (COPD)
3. Current or ex-smoker with smoking history of at least 10 pack years
4. At least one documented exacerbation of COPD in previous year
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; significant alcohol or drug abuse
2. Current clinical diagnosis of asthma requiring steroid treatment
3. History of thoracotomy with pulmonary resection
4. Regular use of daytime oxygen
5. Recent history (within 3 months) of myocardial infarction
6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
9. Recent (within 1 year) hospitalisation for cardiac failure
10. Malignancy requiring chemotherapy or radiotherapy
11. Clinical diagnosis of bronchiectasis
12. Pregnant or nursing women
13. Known hypersensitivity to study drugs
14. Current or recent (within 30 days) participation in another clinical study
15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
2488
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
352.2046.61006 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [2] 0 0
352.2046.61001 Boehringer Ingelheim Investigational Site - Glebe
Recruitment hospital [3] 0 0
352.2046.61002 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [4] 0 0
352.2046.61004 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [5] 0 0
352.2046.61003 Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [6] 0 0
352.2046.61005 Boehringer Ingelheim Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Glebe
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Daw Park
Recruitment postcode(s) [5] 0 0
- Toorak Gardens
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Eupen
Country [3] 0 0
Belgium
State/province [3] 0 0
Gilly
Country [4] 0 0
Belgium
State/province [4] 0 0
Herentals
Country [5] 0 0
Belgium
State/province [5] 0 0
Jambes
Country [6] 0 0
Belgium
State/province [6] 0 0
Lebbeke
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Middelheim
Country [9] 0 0
Belgium
State/province [9] 0 0
Montigny-le-Tilleul
Country [10] 0 0
Belgium
State/province [10] 0 0
Turnhout
Country [11] 0 0
Brazil
State/province [11] 0 0
Goiania
Country [12] 0 0
Brazil
State/province [12] 0 0
Goiânia
Country [13] 0 0
Brazil
State/province [13] 0 0
Porto Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Bourgas
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Rousse
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Stara Zagora
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Veliko Tarnovo
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Chongqing
Country [22] 0 0
China
State/province [22] 0 0
Guangzhou
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
China
State/province [24] 0 0
Wuhan
Country [25] 0 0
Denmark
State/province [25] 0 0
Aarhus C
Country [26] 0 0
Denmark
State/province [26] 0 0
København NV
Country [27] 0 0
Denmark
State/province [27] 0 0
Odense C
Country [28] 0 0
France
State/province [28] 0 0
Brest
Country [29] 0 0
France
State/province [29] 0 0
Castelnau le Lez
Country [30] 0 0
France
State/province [30] 0 0
Clermont Ferrand cedex 1
Country [31] 0 0
France
State/province [31] 0 0
Forbach
Country [32] 0 0
France
State/province [32] 0 0
Marseille cedex 20
Country [33] 0 0
France
State/province [33] 0 0
Marseille
Country [34] 0 0
France
State/province [34] 0 0
Montpellier
Country [35] 0 0
France
State/province [35] 0 0
Nantes Cedex 1
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Nîmes
Country [38] 0 0
France
State/province [38] 0 0
Perpignan
Country [39] 0 0
France
State/province [39] 0 0
Saint Laurent du Var
Country [40] 0 0
France
State/province [40] 0 0
Saint-Pierre cedex
Country [41] 0 0
France
State/province [41] 0 0
Toulouse cedex 9
Country [42] 0 0
France
State/province [42] 0 0
Toulouse
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Bochum
Country [45] 0 0
Germany
State/province [45] 0 0
Cottbus
Country [46] 0 0
Germany
State/province [46] 0 0
Donaustauf
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt/Main
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt
Country [49] 0 0
Germany
State/province [49] 0 0
Geesthacht
Country [50] 0 0
Germany
State/province [50] 0 0
Gelnhausen
Country [51] 0 0
Germany
State/province [51] 0 0
Großhansdorf
Country [52] 0 0
Germany
State/province [52] 0 0
Heidelberg
Country [53] 0 0
Germany
State/province [53] 0 0
Immenhausen
Country [54] 0 0
Germany
State/province [54] 0 0
Kiel
Country [55] 0 0
Germany
State/province [55] 0 0
Köln
Country [56] 0 0
Germany
State/province [56] 0 0
Mainz
Country [57] 0 0
Germany
State/province [57] 0 0
Marburg
Country [58] 0 0
Germany
State/province [58] 0 0
München
Country [59] 0 0
Greece
State/province [59] 0 0
Athens
Country [60] 0 0
Greece
State/province [60] 0 0
Heraklion
Country [61] 0 0
Greece
State/province [61] 0 0
Larisa
Country [62] 0 0
Greece
State/province [62] 0 0
Thessaloniki
Country [63] 0 0
Hungary
State/province [63] 0 0
Cegled
Country [64] 0 0
Hungary
State/province [64] 0 0
Deszk
Country [65] 0 0
Hungary
State/province [65] 0 0
Komarom
Country [66] 0 0
Hungary
State/province [66] 0 0
Pecs
Country [67] 0 0
Hungary
State/province [67] 0 0
Szarvas
Country [68] 0 0
Hungary
State/province [68] 0 0
Szazhalombatta
Country [69] 0 0
Hungary
State/province [69] 0 0
Szigetszentmiklos
Country [70] 0 0
Italy
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Catania
Country [71] 0 0
Italy
State/province [71] 0 0
Cona
Country [72] 0 0
Italy
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Foggia
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Modena
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Montescano (pv)
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Pisa
Country [76] 0 0
Italy
State/province [76] 0 0
Sesto S. Giovanni (mi)
Country [77] 0 0
Italy
State/province [77] 0 0
Tradate (va)
Country [78] 0 0
Netherlands
State/province [78] 0 0
Heerlen
Country [79] 0 0
Netherlands
State/province [79] 0 0
Leeuwarden
Country [80] 0 0
Netherlands
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Rotterdam
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Netherlands
State/province [81] 0 0
Veldhoven
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New Zealand
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Auckland NZ
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
Country [86] 0 0
New Zealand
State/province [86] 0 0
Newtown Wellington NZ
Country [87] 0 0
New Zealand
State/province [87] 0 0
Otahuhu New Zealand
Country [88] 0 0
New Zealand
State/province [88] 0 0
Tauranga
Country [89] 0 0
Philippines
State/province [89] 0 0
Caloocan
Country [90] 0 0
Philippines
State/province [90] 0 0
Manila
Country [91] 0 0
Philippines
State/province [91] 0 0
Muntinlupa
Country [92] 0 0
Philippines
State/province [92] 0 0
Quezon City
Country [93] 0 0
Philippines
State/province [93] 0 0
Quezon
Country [94] 0 0
Poland
State/province [94] 0 0
Bytom
Country [95] 0 0
Poland
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Ostrow Wielkopolska
Country [96] 0 0
Poland
State/province [96] 0 0
Poznan
Country [97] 0 0
Poland
State/province [97] 0 0
Rzeszow
Country [98] 0 0
Poland
State/province [98] 0 0
Tarnowskie Gory
Country [99] 0 0
Poland
State/province [99] 0 0
Warsaw
Country [100] 0 0
Poland
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Wroclaw
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Ekaterinburg
Country [102] 0 0
Russian Federation
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Ivanovo
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Moscow
Country [104] 0 0
Russian Federation
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Samara
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Saratov
Country [106] 0 0
Russian Federation
State/province [106] 0 0
St. Petersburg
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Yaroslavl
Country [108] 0 0
South Africa
State/province [108] 0 0
Amanzimtoti
Country [109] 0 0
South Africa
State/province [109] 0 0
Bellville
Country [110] 0 0
South Africa
State/province [110] 0 0
Cape Town
Country [111] 0 0
South Africa
State/province [111] 0 0
Pretoria
Country [112] 0 0
South Africa
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Somerset West
Country [113] 0 0
South Africa
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Tygerberg
Country [114] 0 0
Spain
State/province [114] 0 0
Badajoz
Country [115] 0 0
Spain
State/province [115] 0 0
Barakaldo (Bilbao)
Country [116] 0 0
Spain
State/province [116] 0 0
Barcelona
Country [117] 0 0
Spain
State/province [117] 0 0
Hospitalet de Llobregat
Country [118] 0 0
Spain
State/province [118] 0 0
Palma de Mallorca
Country [119] 0 0
Spain
State/province [119] 0 0
Pozuelo de Alarcón
Country [120] 0 0
Spain
State/province [120] 0 0
Salt (Girona)
Country [121] 0 0
Spain
State/province [121] 0 0
Sevilla
Country [122] 0 0
Taiwan
State/province [122] 0 0
Kaohsiung
Country [123] 0 0
Taiwan
State/province [123] 0 0
Taichung
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taipei
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taiwan
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Tunisia
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Ariana
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Tunisia
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Sfax
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Tunisia
State/province [128] 0 0
Sousse
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Tunisia
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Tunis
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Ankara
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Turkey
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Bursa
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Turkey
State/province [132] 0 0
Denizli
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Izmit
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Turkey
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Kayseri
Country [137] 0 0
Turkey
State/province [137] 0 0
Mersin
Country [138] 0 0
Turkey
State/province [138] 0 0
Samsun
Country [139] 0 0
Ukraine
State/province [139] 0 0
Ivano-Frankivsk
Country [140] 0 0
Ukraine
State/province [140] 0 0
Kharkiv
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkov
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kiev
Country [143] 0 0
Ukraine
State/province [143] 0 0
Vinnitsa
Country [144] 0 0
Ukraine
State/province [144] 0 0
Vinnytsya
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Baillieston, Glasgow
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Barnsley
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Belfast
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Birmingham
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Cambridge
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Chertsey
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Chesterfield
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Cottingham, Hull
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Inverness
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Isleworth
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Liverpool
Country [156] 0 0
United Kingdom
State/province [156] 0 0
London
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Norwich
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United Kingdom
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Sheffield
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Sunderland
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Windsor

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00975195