Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023516
• Other study ID #: D0520C00020
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2009
• Last updated: June 19, 2012
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Ministry of HealthRomania: National Medicines AgencySlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• 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

• FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator

• Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation

• At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

Exclusion Criteria:

• Past history or current evidence of clinically significant heart disease

• Current diagnosis of asthma

• Patients who require long term oxygen therapy

• Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids 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: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD9668
2 x 30 mg oral tablets bd for 12 weeks
• Placebo
2 x matched placebo to oral tablet bd for 12 weeks

Locations

Country	Name	City	State
Bulgaria	Research Site	Lovech
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Troyan
Bulgaria	Research Site	Varna
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Jindrichuv Hradec
Czech Republic	Research Site	Kladno
Czech Republic	Research Site	Krnov
Czech Republic	Research Site	Novy Jicin
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 5
Czech Republic	Research Site	Rokycany
Czech Republic	Research Site	Trebic
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Deszk
Hungary	Research Site	Gyor
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Pecs
Hungary	Research Site	Szazhalombatta
Hungary	Research Site	Szombathely
Hungary	Research Site	Torokbalint
Hungary	Research Site	Vasarosnameny
Poland	Research Site	Bialystok
Poland	Research Site	Gdynia
Poland	Research Site	Gorzow Wlkp
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Jelenia Gora
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Pila
Poland	Research Site	Skierniewice
Poland	Research Site	Szczecin
Poland	Research Site	Tarnow
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Constanta
Romania	Research Site	Deva	Hunedoara
Romania	Research Site	Iasi
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bojnice
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Dunajska Streda
Slovakia	Research Site	Humenne
Slovakia	Research Site	Kosice
Slovakia	Research Site	Liptovsky Hradok
Slovakia	Research Site	Nove Mesto Nad Vahom
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Poprad
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Presov
Slovakia	Research Site	Revuca
Slovakia	Research Site	Spisska Nova Ves
Slovakia	Research Site	Trnava
Slovakia	Research Site	Trstena
Slovakia	Research Site	Zilina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Hungary,  Poland,  Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Pre-bronchodilator FEV1 (L)	Forced expiratory volume in 1 second (FEV1) 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)	up to week 12	No
Secondary	Post-bronchodilator FEV1 (L) - Baseline	Forced expiratory volume in 1 second (FEV1) 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)	up to week 12	No
Secondary	Pre-bronchodilator FVC (L) - Baseline	Forced vital capacity (FVC) 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)	up to week 12	No
Secondary	Post-bronchodilator FVC (L) - Baseline	Forced vital capacity (FVC) 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)	up to week 12	No
Secondary	Baseline Pre-bronchodilator FEV6 (L)	Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.	Day 1	No
Secondary	End-value Pre-bronchodilator FEV6 (L)	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	up to week 12	No
Secondary	Baseline Post-bronchodilator FEV6 (L)	Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.	Day 1	No
Secondary	End-value Post-bronchodilator FEV6 (L)	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	up to week 12	No
Secondary	Baseline Pre-bronchodilator FEF25-75% (L/Sec)	Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.	Day 1	No
Secondary	End-value Pre-bronchodilator FEF25-75% (L/Sec)	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	up to week 12	No
Secondary	Baseline Post-bronchodilator FEF25-75% (L/Sec)	Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.	Day 1	No
Secondary	End-value Post-bronchodilator FEF25-75% (L/Sec)	End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)	up to week 12	No
Secondary	Pre-bronchodilator IC (L) - Baseline	Inspiratory capacity (IC) 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)	up to week 12	No
Secondary	Post-bronchodilator IC (L) - Baseline	Inspiratory capacity (IC) 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)	up to week 12	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 (PEF)	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	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	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	End of treatment week 12	No
Secondary	Use of Reliever Medication	Daily average of number of inhalations of reliever medication	Last 6 weeks on treatment	No
Secondary	Incremental Shuttle Walk Test - Baseline	Endurance time (s)	Day 1	No
Secondary	Incremental Shuttle Walk Test - End Value		Week 12 - visit 6	No
Secondary	Endurance Shuttle Walk Test - Baseline	Endurance time (s)	Day 1	No
Secondary	Endurance Shuttle Walk Test - End Value	Assessed at vist 6 -( last on treatment clinic visit)	Week 12 - visit 6	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