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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00949975




Registration number
NCT00949975
Ethics application status
Date submitted
21/07/2009
Date registered
31/07/2009
Date last updated
3/08/2012

Titles & IDs
Public title
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Scientific title
A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Secondary ID [1] 0 0
D0520C00012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 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 - AZD9668
Treatment: Drugs - AZD9668
Treatment: Drugs - AZD9668
Treatment: Drugs - AZD9668 Placebo

Active comparator: 1 - AZD9668 active treatment

Active comparator: 2 - AZD9668 active treatment

Active comparator: 3 - AZD9668 active treatment

Placebo comparator: 4 - AZD9668 placebo treatment


Treatment: Drugs: AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks

Treatment: Drugs: AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks

Treatment: Drugs: AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks

Treatment: Drugs: AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline Pre-bronchodilator FEV1 (L)
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
End-value Pre-bronchodilator FEV1 (L)
Timepoint [2] 0 0
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcome [1] 0 0
Post-bronchodilator FEV1 (L) - Baseline
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Post-bronchodilator FEV1 (L) - End-value
Timepoint [2] 0 0
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcome [3] 0 0
Pre-bronchodilator FVC (L) - Baseline
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Pre-bronchodilator FVC (L) - End-value
Timepoint [4] 0 0
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcome [5] 0 0
Post-bronchodilator FVC (L) - Baseline
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
Post-bronchodilator FVC (L) - End-value
Timepoint [6] 0 0
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcome [7] 0 0
Pre-bronchodilator IC (L) - Baseline
Timepoint [7] 0 0
Day 1
Secondary outcome [8] 0 0
Pre-bronchodilator IC (L) - End-value
Timepoint [8] 0 0
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcome [9] 0 0
Post-bronchodilator IC (L) - Baseline
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Post-bronchodilator IC (L) - End-value
Timepoint [10] 0 0
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcome [11] 0 0
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Timepoint [11] 0 0
Baseline
Secondary outcome [12] 0 0
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Timepoint [12] 0 0
Last 6 weeks on treatment
Secondary outcome [13] 0 0
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Timepoint [14] 0 0
Last 6 weeks on treatment
Secondary outcome [15] 0 0
EXACT - Baseline Total Score
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
EXACT - End-value Total Score
Timepoint [16] 0 0
Measured daily in the evening for 12 weeks
Secondary outcome [17] 0 0
BCSS - Baseline Total Score
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
BCSS - End-value Total Score
Timepoint [18] 0 0
Measured daily in the evening for 12 weeks
Secondary outcome [19] 0 0
Sputum Colour - Baseline
Timepoint [19] 0 0
Baseline
Secondary outcome [20] 0 0
Sputum Colour - End Value
Timepoint [20] 0 0
Measured at clinic visits:1, 4, 8 and 12 weeks
Secondary outcome [21] 0 0
Use of Reliever Medication
Timepoint [21] 0 0
Last 6 weeks on treatment
Secondary outcome [22] 0 0
Six-minute Walk Test - Distance Walked at Baseline (m)
Timepoint [22] 0 0
Day 1
Secondary outcome [23] 0 0
Six-minute Walk Test - End-value Distance Walked (m)
Timepoint [23] 0 0
Measured Day 1 and 12 weeks
Secondary outcome [24] 0 0
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
Timepoint [24] 0 0
Day 1
Secondary outcome [25] 0 0
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
Timepoint [25] 0 0
Measured Day 1 and 12 weeks
Secondary outcome [26] 0 0
Exacerbations - Clinic Defined
Timepoint [26] 0 0
Duration of the the treatment period - 12 weeks

Eligibility
Key inclusion criteria
* Diagnosis of COPD with symptoms over 1 year
* Smokers or ex-smokers
* Males or post-menopausal females between 40 and 80 years old
* Able to use electronic devices
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Past history or current evidence of clinically significant heart disease
* Current diagnosis of asthma
* Patients who require long term oxygen therapy
* Treatment with antibiotics within 4 weeks of study visit 1b

Study design
Purpose of the study
Other
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 2
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
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
838
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 - Glebe
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment hospital [4] 0 0
Research Site - Carina Heights
Recruitment hospital [5] 0 0
Research Site - Adelaide
Recruitment hospital [6] 0 0
Research Site - Daw Park
Recruitment hospital [7] 0 0
Research Site - Parkville
Recruitment hospital [8] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Glebe
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Carina Heights
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Daw Park
Recruitment postcode(s) [7] 0 0
- Parkville
Recruitment postcode(s) [8] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Newfoundland and Labrador
Country [11] 0 0
Canada
State/province [11] 0 0
Nova Scotia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Canada
State/province [14] 0 0
Saskatchewan
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Fulda
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
Germany
State/province [19] 0 0
Marburg
Country [20] 0 0
Japan
State/province [20] 0 0
Aichi
Country [21] 0 0
Japan
State/province [21] 0 0
Chiba
Country [22] 0 0
Japan
State/province [22] 0 0
Ehime
Country [23] 0 0
Japan
State/province [23] 0 0
Fukuoka
Country [24] 0 0
Japan
State/province [24] 0 0
Fukushima
Country [25] 0 0
Japan
State/province [25] 0 0
Hokkaido
Country [26] 0 0
Japan
State/province [26] 0 0
Hyogo
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Kyoto
Country [29] 0 0
Japan
State/province [29] 0 0
Nagano
Country [30] 0 0
Japan
State/province [30] 0 0
Oita
Country [31] 0 0
Japan
State/province [31] 0 0
Osaka
Country [32] 0 0
Japan
State/province [32] 0 0
Shimane
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Wakayama
Country [35] 0 0
Japan
State/province [35] 0 0
Bunkyo
Country [36] 0 0
Japan
State/province [36] 0 0
Hiroshima
Country [37] 0 0
Japan
State/province [37] 0 0
Kagoshima
Country [38] 0 0
Japan
State/province [38] 0 0
Kochi
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Gyeonggi-do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Kangwon-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Anyang
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Bucheon
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Daegu
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Philippines
State/province [45] 0 0
Iloilo City
Country [46] 0 0
Philippines
State/province [46] 0 0
Lipa City, Batangas
Country [47] 0 0
Philippines
State/province [47] 0 0
Quezon City
Country [48] 0 0
Poland
State/province [48] 0 0
Bydgoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Checiny
Country [50] 0 0
Poland
State/province [50] 0 0
Krakow
Country [51] 0 0
Poland
State/province [51] 0 0
Ostrow Wielkopolski
Country [52] 0 0
Poland
State/province [52] 0 0
Poznan
Country [53] 0 0
Poland
State/province [53] 0 0
Proszowice
Country [54] 0 0
Poland
State/province [54] 0 0
Tczew
Country [55] 0 0
Poland
State/province [55] 0 0
Wroclaw
Country [56] 0 0
Poland
State/province [56] 0 0
Zawadzkie
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Russia
Country [58] 0 0
Slovakia
State/province [58] 0 0
Bardejov
Country [59] 0 0
Slovakia
State/province [59] 0 0
Bojnice
Country [60] 0 0
Slovakia
State/province [60] 0 0
Bratislava
Country [61] 0 0
Slovakia
State/province [61] 0 0
Kosice
Country [62] 0 0
Slovakia
State/province [62] 0 0
Nove Mesto Nad Vahom
Country [63] 0 0
Slovakia
State/province [63] 0 0
Nove Zamky
Country [64] 0 0
Slovakia
State/province [64] 0 0
Poprad
Country [65] 0 0
Slovakia
State/province [65] 0 0
Presov
Country [66] 0 0
Slovakia
State/province [66] 0 0
Trnava
Country [67] 0 0
Slovakia
State/province [67] 0 0
Zilina
Country [68] 0 0
Slovakia
State/province [68] 0 0
Zvolen
Country [69] 0 0
Taiwan
State/province [69] 0 0
Kaohsiung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Keelung
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taichung
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taipei
Country [73] 0 0
Taiwan
State/province [73] 0 0
Tao-yuan
Country [74] 0 0
Ukraine
State/province [74] 0 0
Dnipropetrovsk
Country [75] 0 0
Ukraine
State/province [75] 0 0
Ivano-frankivsk
Country [76] 0 0
Ukraine
State/province [76] 0 0
Kharkiv
Country [77] 0 0
Ukraine
State/province [77] 0 0
Kyiv
Country [78] 0 0
Ukraine
State/province [78] 0 0
Lugansk

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
Trial website
https://clinicaltrials.gov/study/NCT00949975
Trial related presentations / publications
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
Vogelmeier C, Aquino TO, O'Brien CD, Perrett J, Gunawardena KA. A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. COPD. 2012 Apr;9(2):111-20. doi: 10.3109/15412555.2011.641803.
Public notes

Contacts
Principal investigator
Name 0 0
Claus Volgemeier, Dr.
Address 0 0
Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
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/NCT00949975