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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949975
• Other study ID #: D0520C00012
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2009
• Last updated: June 19, 2012
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesJapan: Ministry of Health, Labor and WelfarePhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of HealthUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 838
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
• AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
• AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
• AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Carina Heights	Queensland
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Daw Park	South Australia
Australia	Research Site	Glebe	New South Wales
Australia	Research Site	Kogarah	New South Wales
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	Parkville	Victoria
Canada	Research Site	Antigonish	Nova Scotia
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Grimsby	Ontario
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	La Malbaie	Quebec
Canada	Research Site	Mirabel	Quebec
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Quebec
Canada	Research Site	Saint-leonard	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Germany	Research Site	Berlin
Germany	Research Site	Fulda
Germany	Research Site	Hannover
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
Japan	Research Site	Asahikawa	Hokkaido
Japan	Research Site	Bunkyo
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Fukuoka
Japan	Research Site	Himeji	Hyogo
Japan	Research Site	Hiroshima
Japan	Research Site	Kagoshima
Japan	Research Site	Kawasaki	Kanagawa
Japan	Research Site	Kishiwada	Osaka
Japan	Research Site	Kita-ku, Sakai	Osaka
Japan	Research Site	Kochi
Japan	Research Site	Matsue	Shimane
Japan	Research Site	Matsumoto	Nagano
Japan	Research Site	Nakano-ku	Tokyo
Japan	Research Site	Nihonmatsu	Fukushima
Japan	Research Site	Noda	Chiba
Japan	Research Site	Saeki	Oita
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Seto	Aichi
Japan	Research Site	Tanabe	Wakayama
Japan	Research Site	Touon	Ehime
Japan	Research Site	Ukyo-ku, Kyoto	Kyoto
Japan	Research Site	Yokohama	Kanagawa
Japan	Research Site	Yukuhashi	Fukuoka
Korea, Republic of	Research Site	Anyang
Korea, Republic of	Research Site	Bucheon
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Uijeongbu	Gyeonggi-do
Korea, Republic of	Research Site	Wonju	Kangwon-do
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City, Batangas
Philippines	Research Site	Quezon City
Poland	Research Site	Bydgoszcz
Poland	Research Site	Checiny
Poland	Research Site	Krakow
Poland	Research Site	Ostrow Wielkopolski
Poland	Research Site	Poznan
Poland	Research Site	Proszowice
Poland	Research Site	Tczew
Poland	Research Site	Wroclaw
Poland	Research Site	Zawadzkie
Russian Federation	Research Site	Barnaul	Russia
Russian Federation	Research Site	Ekaterinburg	Russia
Russian Federation	Research Site	Kazan	Russia
Russian Federation	Research Site	Moscow	Russia
Russian Federation	Research Site	Novosibirsk	Russia
Russian Federation	Research Site	St.petersburg	Russia
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bojnice
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Nove Mesto Nad Vahom
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Poprad
Slovakia	Research Site	Presov
Slovakia	Research Site	Trnava
Slovakia	Research Site	Zilina
Slovakia	Research Site	Zvolen
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Keelung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Tao-yuan
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Ivano-frankivsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lugansk
United States	Research Site	Boerne	Texas
United States	Research Site	Council Bluffs	Iowa
United States	Research Site	Fullerton	California
United States	Research Site	Gaffney	South Carolina
United States	Research Site	Greenville	South Carolina
United States	Research Site	Hickory	North Carolina
United States	Research Site	Jefferson Hills	Pennsylvania
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Valparaiso	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Japan,  Korea, Republic of,  Philippines,  Poland,  Russian Federation,  Slovakia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Pre-bronchodilator FEV1 (L)	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic	Day 1	No
Primary	End-value Pre-bronchodilator FEV1 (L)	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	Measured at clinic visits: 1, 4, 8 and 12 weeks	No
Secondary	Post-bronchodilator FEV1 (L) - Baseline	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic	Day 1	No
Secondary	Post-bronchodilator FEV1 (L) - End-value	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	Measured at clinic visits: 1, 4, 8 and 12 weeks	No
Secondary	Pre-bronchodilator FVC (L) - Baseline	Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic	Day 1	No
Secondary	Pre-bronchodilator FVC (L) - End-value	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	Measured at clinic visits: 1, 4, 8 and 12 weeks	No
Secondary	Post-bronchodilator FVC (L) - Baseline	Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic	Day 1	No
Secondary	Post-bronchodilator FVC (L) - End-value	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	Measured at clinic visits: 1, 4, 8 and 12 weeks	No
Secondary	Pre-bronchodilator IC (L) - Baseline	Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic	Day 1	No
Secondary	Pre-bronchodilator IC (L) - End-value	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	Measured at clinic visits: 1, 4, 8 and 12 weeks	No
Secondary	Post-bronchodilator IC (L) - Baseline	Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic	Day 1	No
Secondary	Post-bronchodilator IC (L) - End-value	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	Measured at clinic visits: 1, 4, 8 and 12 weeks	No
Secondary	PEF - Baseline Measured by Patient at Home (L/Min) in the Morning	Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment	Baseline	No
Secondary	PEF - End-value Measured by Patient at Home (L/Min) in the Morning	Peak Expiratory Flow (L/min)	Last 6 weeks on treatment	No
Secondary	FEV1 - Baseline Measured by Patient at Home (L) in the Morning	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment	Baseline	No
Secondary	FEV1 - End-value Measured by Patient at Home (L) in the Morning	Forced Expiratory Volume in 1 second (L)	Last 6 weeks on treatment	No
Secondary	EXACT - Baseline Total Score	EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.	Baseline	No
Secondary	EXACT - End-value Total Score	EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.	Measured daily in the evening for 12 weeks	No
Secondary	BCSS - Baseline Total Score	Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment	Baseline	No
Secondary	BCSS - End-value Total Score	Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment	Measured daily in the evening for 12 weeks	No
Secondary	Sputum Colour - Baseline	Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).	Baseline	No
Secondary	Sputum Colour - End Value	Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12	Measured at clinic visits:1, 4, 8 and 12 weeks	No
Secondary	Use of Reliever Medication	Daily average of number of inhalations of reliever medication	Last 6 weeks on treatment	No
Secondary	Six-minute Walk Test - Distance Walked at Baseline (m)		Day 1	No
Secondary	Six-minute Walk Test - End-value Distance Walked (m)	distance walked on vist 6 - last on treatment clinic visit	Measured Day 1 and 12 weeks	No
Secondary	St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline	St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).	Day 1	No
Secondary	St George's Respiratory Questionnaire (COPD) - End-value Overall Score	St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)	Measured Day 1 and 12 weeks	No
Secondary	Exacerbations - Clinic Defined	Number of patients having a clinic defined disease exacerbation	Duration of the the treatment period - 12 weeks	No