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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00949975
First received: July 21, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: AZD9668
Drug: AZD9668 Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Baseline Pre-bronchodilator FEV1 (L) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

  • End-value Pre-bronchodilator FEV1 (L) [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)


Secondary Outcome Measures:
  • Post-bronchodilator FEV1 (L) - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic

  • Post-bronchodilator FEV1 (L) - End-value [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • Pre-bronchodilator FVC (L) - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

  • Pre-bronchodilator FVC (L) - End-value [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • Post-bronchodilator FVC (L) - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic

  • Post-bronchodilator FVC (L) - End-value [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • Pre-bronchodilator IC (L) - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

  • Pre-bronchodilator IC (L) - End-value [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • Post-bronchodilator IC (L) - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic

  • Post-bronchodilator IC (L) - End-value [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • PEF - Baseline Measured by Patient at Home (L/Min) in the Morning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • PEF - End-value Measured by Patient at Home (L/Min) in the Morning [ Time Frame: Last 6 weeks on treatment ] [ Designated as safety issue: No ]
    Peak Expiratory Flow (L/min)

  • FEV1 - Baseline Measured by Patient at Home (L) in the Morning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • FEV1 - End-value Measured by Patient at Home (L) in the Morning [ Time Frame: Last 6 weeks on treatment ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (L)

  • EXACT - Baseline Total Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • EXACT - End-value Total Score [ Time Frame: Measured daily in the evening for 12 weeks ] [ Designated as safety issue: No ]
    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.

  • BCSS - Baseline Total Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • BCSS - End-value Total Score [ Time Frame: Measured daily in the evening for 12 weeks ] [ Designated as safety issue: No ]
    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

  • Sputum Colour - Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Sputum Colour - End Value [ Time Frame: Measured at clinic visits:1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    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

  • Use of Reliever Medication [ Time Frame: Last 6 weeks on treatment ] [ Designated as safety issue: No ]
    Daily average of number of inhalations of reliever medication

  • Six-minute Walk Test - Distance Walked at Baseline (m) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Six-minute Walk Test - End-value Distance Walked (m) [ Time Frame: Measured Day 1 and 12 weeks ] [ Designated as safety issue: No ]
    distance walked on vist 6 - last on treatment clinic visit

  • St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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)).

  • St George's Respiratory Questionnaire (COPD) - End-value Overall Score [ Time Frame: Measured Day 1 and 12 weeks ] [ Designated as safety issue: No ]
    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)

  • Exacerbations - Clinic Defined [ Time Frame: Duration of the the treatment period - 12 weeks ] [ Designated as safety issue: No ]
    Number of patients having a clinic defined disease exacerbation


Enrollment: 838
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AZD9668 active treatment
Drug: AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Active Comparator: 2
AZD9668 active treatment
Drug: AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
Active Comparator: 3
AZD9668 active treatment
Drug: AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
Placebo Comparator: 4
AZD9668 placebo treatment
Drug: AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949975

  Show 105 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Claus Volgemeier, Dr. Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00949975     History of Changes
Other Study ID Numbers: D0520C00012
Study First Received: July 21, 2009
Results First Received: January 24, 2012
Last Updated: June 19, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Chronic
Obstructive
Pulmonary
Lung
Respiratory disease
Efficacy
Safety and tolerability
Placebo-controlled
Pharmacokinetics
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014