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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00496470




Registration number
NCT00496470
Ethics application status
Date submitted
3/07/2007
Date registered
4/07/2007
Date last updated
9/11/2012

Titles & IDs
Public title
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
Scientific title
A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
Secondary ID [1] 0 0
Eudract no:2006-006796-21
Secondary ID [2] 0 0
D5892C00015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease, COPD 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 - Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Treatment: Drugs - Spiriva (tiotropium bromide 18ug)

Active comparator: Symbicort+TIO - Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily

Active comparator: Spiriva® + Placebo Turbuhaler - Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily


Treatment: Drugs: Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Treatment: Drugs: Spiriva (tiotropium bromide 18ug)
Spiriva (tiotropium bromide 18ug)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Timepoint [1] 0 0
Baseline to 12 weeks
Secondary outcome [1] 0 0
Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Timepoint [1] 0 0
Baseline to 12 weeks
Secondary outcome [2] 0 0
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Timepoint [2] 0 0
Baseline to 12 weeks
Secondary outcome [3] 0 0
Forced Vital Capacity (FVC) Pre-dose
Timepoint [3] 0 0
Baseline to 12 weeks
Secondary outcome [4] 0 0
Forced Vital Capacity (FVC) 5 Minutes Post-dose
Timepoint [4] 0 0
Baseline to 12 weeks
Secondary outcome [5] 0 0
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Timepoint [5] 0 0
Baseline to 12 weeks
Secondary outcome [6] 0 0
Inspiratory Capacity (IC) Pre-dose
Timepoint [6] 0 0
Baseline to 12 weeks
Secondary outcome [7] 0 0
Inspiratory Capacity (IC) 60 Minutes Post-dose
Timepoint [7] 0 0
Baseline to 12 weeks
Secondary outcome [8] 0 0
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
Timepoint [8] 0 0
Baseline and 12 weeks
Secondary outcome [9] 0 0
Morning Peak Expiratory Flow (PEF) Pre-dose
Timepoint [9] 0 0
Baseline to 12 weeks
Secondary outcome [10] 0 0
Evening Peak Expiratory Flow (PEF) Pre-dose
Timepoint [10] 0 0
Baseline to 12 weeks
Secondary outcome [11] 0 0
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Timepoint [11] 0 0
Baseline to 12 weeks
Secondary outcome [12] 0 0
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Timepoint [12] 0 0
Baseline to 12 weeks
Secondary outcome [13] 0 0
Morning Diary FEV1 Pre-dose
Timepoint [13] 0 0
Baseline to 12 weeks
Secondary outcome [14] 0 0
Evening Diary FEV1, Pre-dose
Timepoint [14] 0 0
Baseline to 12 weeks
Secondary outcome [15] 0 0
Morning Diary FEV1, 5 Minutes Post-dose
Timepoint [15] 0 0
Baseline to 12 weeks
Secondary outcome [16] 0 0
Morning Diary FEV1, 15 Minutes Post-dose
Timepoint [16] 0 0
Baseline to 12 weeks
Secondary outcome [17] 0 0
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
Timepoint [17] 0 0
Baseline to 12 weeks
Secondary outcome [18] 0 0
GCSQ Score, 5 Minutes Post-dose
Timepoint [18] 0 0
Baseline to 12 weeks
Secondary outcome [19] 0 0
GCSQ Score, 15 Minutes Post-dose
Timepoint [19] 0 0
Baseline to 12 weeks
Secondary outcome [20] 0 0
Capacity of Day Living in the Morning (CDLM) Score
Timepoint [20] 0 0
Baseline to 12 weeks
Secondary outcome [21] 0 0
Use of Rescue Medication, Night
Timepoint [21] 0 0
Baseline to 12 weeks
Secondary outcome [22] 0 0
Use of Rescue Medication, Morning
Timepoint [22] 0 0
Baseline to 12 weeks
Secondary outcome [23] 0 0
Use of Rescue Medication, Day
Timepoint [23] 0 0
Baseline to 12 weeks
Secondary outcome [24] 0 0
Use of Rescue Medication, Total
Timepoint [24] 0 0
Baseline to 12 weeks
Secondary outcome [25] 0 0
COPD Symptoms, Breathing Score
Timepoint [25] 0 0
Baseline to 12 weeks
Secondary outcome [26] 0 0
COPD Symptoms, Sleeping Score
Timepoint [26] 0 0
Baseline to 12 weeks
Secondary outcome [27] 0 0
COPD Symptoms, Chest Score
Timepoint [27] 0 0
Baseline to 12 weeks
Secondary outcome [28] 0 0
COPD Symptoms, Cough Score
Timepoint [28] 0 0
Baseline to 12 weeks
Secondary outcome [29] 0 0
Severe COPD Exacerbations
Timepoint [29] 0 0
12 weeks
Secondary outcome [30] 0 0
Serum High-sensitivity C-reactive Protein (hsCRP)
Timepoint [30] 0 0
Baseline to 12 weeks
Secondary outcome [31] 0 0
Serum Interleukin 6 (IL-6)
Timepoint [31] 0 0
Baseline to 12 weeks
Secondary outcome [32] 0 0
Serum Interleukin 8 (IL-8)
Timepoint [32] 0 0
Baseline to 12 weeks
Secondary outcome [33] 0 0
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Timepoint [33] 0 0
Baseline to 12 weeks
Secondary outcome [34] 0 0
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Timepoint [34] 0 0
Baseline to 12 weeks
Secondary outcome [35] 0 0
Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Timepoint [35] 0 0
Baseline to 12 weeks
Secondary outcome [36] 0 0
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Timepoint [36] 0 0
Baseline to 12 weeks

Eligibility
Key inclusion criteria
* >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder

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 administering the treatment/s
The people assessing the outcomes
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
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
660
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Concord
Recruitment hospital [2] 0 0
Research Site - Sydney
Recruitment hospital [3] 0 0
Research Site - Auchenflower
Recruitment hospital [4] 0 0
Research Site - Carina Heights
Recruitment hospital [5] 0 0
Research Site - North Mackay
Recruitment hospital [6] 0 0
Research Site - Adelaide
Recruitment hospital [7] 0 0
Research Site - Daw Park
Recruitment hospital [8] 0 0
Research Site - Clayton
Recruitment hospital [9] 0 0
Research Site - Malvern
Recruitment hospital [10] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Auchenflower
Recruitment postcode(s) [4] 0 0
- Carina Heights
Recruitment postcode(s) [5] 0 0
- North Mackay
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Daw Park
Recruitment postcode(s) [8] 0 0
- Clayton
Recruitment postcode(s) [9] 0 0
- Malvern
Recruitment postcode(s) [10] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
France
State/province [9] 0 0
Chamalieres
Country [10] 0 0
France
State/province [10] 0 0
Creil
Country [11] 0 0
France
State/province [11] 0 0
Ferolles Attilly
Country [12] 0 0
France
State/province [12] 0 0
Grasse
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Marseille Cedex 06
Country [15] 0 0
France
State/province [15] 0 0
Metz
Country [16] 0 0
France
State/province [16] 0 0
Montpellier
Country [17] 0 0
France
State/province [17] 0 0
Perpignan
Country [18] 0 0
France
State/province [18] 0 0
Poitiers Cedex
Country [19] 0 0
France
State/province [19] 0 0
Selestat
Country [20] 0 0
France
State/province [20] 0 0
St Laurent Du Var
Country [21] 0 0
France
State/province [21] 0 0
Strasbourg Cedex
Country [22] 0 0
France
State/province [22] 0 0
Toulouse Cedex 9
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Gelsenkirchen
Country [25] 0 0
Germany
State/province [25] 0 0
Hagen
Country [26] 0 0
Germany
State/province [26] 0 0
Hannover
Country [27] 0 0
Germany
State/province [27] 0 0
Kassel
Country [28] 0 0
Germany
State/province [28] 0 0
Koblenz
Country [29] 0 0
Germany
State/province [29] 0 0
Leipzig
Country [30] 0 0
Germany
State/province [30] 0 0
Marburg
Country [31] 0 0
Germany
State/province [31] 0 0
Potsdam
Country [32] 0 0
Hungary
State/province [32] 0 0
Aszod
Country [33] 0 0
Hungary
State/province [33] 0 0
Baja
Country [34] 0 0
Hungary
State/province [34] 0 0
Balassagyarmat
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Cegled
Country [37] 0 0
Hungary
State/province [37] 0 0
Debrecen
Country [38] 0 0
Hungary
State/province [38] 0 0
Fuzesabony
Country [39] 0 0
Hungary
State/province [39] 0 0
Jaszbereny
Country [40] 0 0
Hungary
State/province [40] 0 0
Komlo
Country [41] 0 0
Hungary
State/province [41] 0 0
Nyiregyhaza
Country [42] 0 0
Hungary
State/province [42] 0 0
Torokbalint
Country [43] 0 0
Hungary
State/province [43] 0 0
Vásárosnamény
Country [44] 0 0
Poland
State/province [44] 0 0
Bydgoszcz
Country [45] 0 0
Poland
State/province [45] 0 0
Chrzanów
Country [46] 0 0
Poland
State/province [46] 0 0
Ilawa
Country [47] 0 0
Poland
State/province [47] 0 0
Krakow
Country [48] 0 0
Poland
State/province [48] 0 0
Lomza
Country [49] 0 0
Poland
State/province [49] 0 0
Piekary Slaskie
Country [50] 0 0
Poland
State/province [50] 0 0
Tarnow
Country [51] 0 0
Poland
State/province [51] 0 0
Turek
Country [52] 0 0
Poland
State/province [52] 0 0
Zawadzkie
Country [53] 0 0
Slovakia
State/province [53] 0 0
Kosice
Country [54] 0 0
Slovakia
State/province [54] 0 0
Liptovsky Hradok
Country [55] 0 0
Slovakia
State/province [55] 0 0
Lucenec
Country [56] 0 0
Slovakia
State/province [56] 0 0
Nove Mesto Nad Vahom
Country [57] 0 0
Slovakia
State/province [57] 0 0
Nove Zamky
Country [58] 0 0
Slovakia
State/province [58] 0 0
Piestany
Country [59] 0 0
Slovakia
State/province [59] 0 0
Poprad
Country [60] 0 0
Slovakia
State/province [60] 0 0
Povazska Bystrica
Country [61] 0 0
Slovakia
State/province [61] 0 0
Presov
Country [62] 0 0
Slovakia
State/province [62] 0 0
Prievidza
Country [63] 0 0
Slovakia
State/province [63] 0 0
Revuca
Country [64] 0 0
Slovakia
State/province [64] 0 0
Trnava
Country [65] 0 0
Slovakia
State/province [65] 0 0
Zilina
Country [66] 0 0
Spain
State/province [66] 0 0
Cataluna
Country [67] 0 0
Spain
State/province [67] 0 0
Comunidad de Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Comunidad Valenciana
Country [69] 0 0
Spain
State/province [69] 0 0
Galicia
Country [70] 0 0
Sweden
State/province [70] 0 0
Orebro Lan
Country [71] 0 0
Sweden
State/province [71] 0 0
Atvidaberg
Country [72] 0 0
Sweden
State/province [72] 0 0
Hollviken
Country [73] 0 0
Sweden
State/province [73] 0 0
Limhamn
Country [74] 0 0
Sweden
State/province [74] 0 0
Lund
Country [75] 0 0
Sweden
State/province [75] 0 0
Malmo
Country [76] 0 0
Sweden
State/province [76] 0 0
Motala
Country [77] 0 0
Sweden
State/province [77] 0 0
Stockholm
Country [78] 0 0
Sweden
State/province [78] 0 0
Uppsala

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tomas Andersson, MD
Address 0 0
AstraZeneca R&D Lund
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/NCT00496470