Clinical trial NCT00949975: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic
Obstructive
Pulmonary
Lung
Respiratory disease
Efficacy
Safety and tolerability
Placebo-controlled
Pharmacokinetics
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-31
Enrollment: 838
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Baseline Pre-bronchodilator FEV1 (L)
timeFrame: Day 1
measure: End-value Pre-bronchodilator FEV1 (L)
timeFrame: Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcomes:
measure: Post-bronchodilator FEV1 (L) - Baseline
timeFrame: Day 1
measure: Post-bronchodilator FEV1 (L) - End-value
timeFrame: Measured at clinic visits: 1, 4, 8 and 12 weeks
measure: Pre-bronchodilator FVC (L) - Baseline
timeFrame: Day 1
measure: Pre-bronchodilator FVC (L) - End-value
timeFrame: Measured at clinic visits: 1, 4, 8 and 12 weeks
measure: Post-bronchodilator FVC (L) - Baseline
timeFrame: Day 1
measure: Post-bronchodilator FVC (L) - End-value
timeFrame: Measured at clinic visits: 1, 4, 8 and 12 weeks
measure: Pre-bronchodilator IC (L) - Baseline
timeFrame: Day 1
measure: Pre-bronchodilator IC (L) - End-value
timeFrame: Measured at clinic visits: 1, 4, 8 and 12 weeks
measure: Post-bronchodilator IC (L) - Baseline
timeFrame: Day 1
measure: Post-bronchodilator IC (L) - End-value
timeFrame: Measured at clinic visits: 1, 4, 8 and 12 weeks
measure: PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
timeFrame: Baseline
measure: PEF - End-value Measured by Patient at Home (L/Min) in the Morning
timeFrame: Last 6 weeks on treatment
measure: FEV1 - Baseline Measured by Patient at Home (L) in the Morning
timeFrame: Baseline
measure: FEV1 - End-value Measured by Patient at Home (L) in the Morning
timeFrame: Last 6 weeks on treatment
measure: EXACT - Baseline Total Score
timeFrame: Baseline
measure: EXACT - End-value Total Score
timeFrame: Measured daily in the evening for 12 weeks
measure: BCSS - Baseline Total Score
timeFrame: Baseline
measure: BCSS - End-value Total Score
timeFrame: Measured daily in the evening for 12 weeks
measure: Sputum Colour - Baseline
timeFrame: Baseline
measure: Sputum Colour - End Value
timeFrame: Measured at clinic visits:1, 4, 8 and 12 weeks
measure: Use of Reliever Medication
timeFrame: Last 6 weeks on treatment
measure: Six-minute Walk Test - Distance Walked at Baseline (m)
timeFrame: Day 1
measure: Six-minute Walk Test - End-value Distance Walked (m)
timeFrame: Measured Day 1 and 12 weeks
measure: St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
timeFrame: Day 1
measure: St George's Respiratory Questionnaire (COPD) - End-value Overall Score
timeFrame: Measured Day 1 and 12 weeks
measure: Exacerbations - Clinic Defined
timeFrame: Duration of the the treatment period - 12 weeks
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Research Site
state: California
city: Valparaiso
country: United States
facility: Research Site
state: Indiana
city: Council Bluffs
country: United States
facility: Research Site
state: Iowa
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Jefferson Hills
country: United States
facility: Research Site
state: Pennsylvania
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Boerne
country: United States
facility: Research Site
state: Texas
city: Concord
country: Australia
facility: Research Site
state: New South Wales
city: Glebe
country: Australia
facility: Research Site
state: New South Wales
city: Kogarah
country: Australia
facility: Research Site
state: New South Wales
city: Carina Heights
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Daw Park
country: Australia
facility: Research Site
state: South Australia
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Antigonish
country: Canada
facility: Research Site
state: Nova Scotia
city: Grimsby
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: La Malbaie
country: Canada
facility: Research Site
state: Quebec
city: Mirabel
country: Canada
facility: Research Site
state: Quebec
city: Saint-leonard
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Noda
country: Japan
facility: Research Site
state: Chiba
city: Touon
country: Japan
facility: Research Site
state: Ehime
city: Yukuhashi
country: Japan
facility: Research Site
state: Fukuoka
city: Nihonmatsu
country: Japan
facility: Research Site
state: Fukushima
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Himeji
country: Japan
facility: Research Site
state: Hyogo
city: Kawasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Ukyo-ku, Kyoto
country: Japan
facility: Research Site
state: Kyoto
city: Matsumoto
country: Japan
facility: Research Site
state: Nagano
city: Saeki
country: Japan
facility: Research Site
state: Oita
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Kita-ku, Sakai
country: Japan
facility: Research Site
state: Osaka
city: Matsue
country: Japan
facility: Research Site
state: Shimane
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Research Site
state: Tokyo
city: Tanabe
country: Japan
facility: Research Site
state: Wakayama
city: Bunkyo
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Uijeongbu
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Kangwon-do
city: Anyang
country: Korea, Republic of
facility: Research Site
city: Bucheon
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Lipa City, Batangas
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Checiny
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Ostrow Wielkopolski
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Tczew
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zawadzkie
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
state: Russia
city: Ekaterinburg
country: Russian Federation
facility: Research Site
state: Russia
city: Kazan
country: Russian Federation
facility: Research Site
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
city: Novosibirsk
country: Russian Federation
facility: Research Site
state: Russia
city: St.petersburg
country: Russian Federation
facility: Research Site
state: Russia
city: Bardejov
country: Slovakia
facility: Research Site
city: Bojnice
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Nove Mesto Nad Vahom
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Zvolen
country: Slovakia
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Keelung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-yuan
country: Taiwan
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Ivano-frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
Study officials:
affiliation: Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
name: Claus Volgemeier, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.