Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Concord, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9668

Drug

2 x 30 mg oral tablets twice daily (bid) for 12 weeks

AZD9668 Placebo

Drug

2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

Primary outcomes

  1. Baseline Pre-bronchodilator FEV1 (L)

    Time frame: Day 1

    Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

  2. End-value Pre-bronchodilator FEV1 (L)

    Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks

    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

Secondary outcomes

  1. Post-bronchodilator FEV1 (L) - Baseline

    Time frame: Day 1

    Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic

  2. Post-bronchodilator FEV1 (L) - End-value

    Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks

    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  3. Pre-bronchodilator FVC (L) - Baseline

    Time frame: Day 1

    Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

  4. Pre-bronchodilator FVC (L) - End-value

    Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks

    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  5. Post-bronchodilator FVC (L) - Baseline

    Time frame: Day 1

    Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic

  6. Post-bronchodilator FVC (L) - End-value

    Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks

    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  7. Pre-bronchodilator IC (L) - Baseline

    Time frame: Day 1

    Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic

  8. Pre-bronchodilator IC (L) - End-value

    Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks

    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  9. Post-bronchodilator IC (L) - Baseline

    Time frame: Day 1

    Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic

  10. Post-bronchodilator IC (L) - End-value

    Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks

    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  11. PEF - Baseline Measured by Patient at Home (L/Min) in the Morning

    Time frame: Baseline

    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

  12. PEF - End-value Measured by Patient at Home (L/Min) in the Morning

    Time frame: Last 6 weeks on treatment

    Peak Expiratory Flow (L/min)

  13. FEV1 - Baseline Measured by Patient at Home (L) in the Morning

    Time frame: Baseline

    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

  14. FEV1 - End-value Measured by Patient at Home (L) in the Morning

    Time frame: Last 6 weeks on treatment

    Forced Expiratory Volume in 1 second (L)

  15. EXACT - Baseline Total Score

    Time frame: Baseline

    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.

  16. EXACT - End-value Total Score

    Time frame: Measured daily in the evening for 12 weeks

    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.

  17. BCSS - Baseline Total Score

    Time frame: Baseline

    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

  18. BCSS - End-value Total Score

    Time frame: Measured daily in the evening for 12 weeks

    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

  19. Sputum Colour - Baseline

    Time frame: 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).

  20. Sputum Colour - End Value

    Time frame: Measured at clinic visits:1, 4, 8 and 12 weeks

    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

  21. Use of Reliever Medication

    Time frame: Last 6 weeks on treatment

    Daily average of number of inhalations of reliever medication

  22. Six-minute Walk Test - Distance Walked at Baseline (m)

    Time frame: Day 1

  23. Six-minute Walk Test - End-value Distance Walked (m)

    Time frame: Measured Day 1 and 12 weeks

    distance walked on vist 6 - last on treatment clinic visit

  24. St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline

    Time frame: Day 1

    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)).

  25. St George's Respiratory Questionnaire (COPD) - End-value Overall Score

    Time frame: Measured Day 1 and 12 weeks

    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)

  26. Exacerbations - Clinic Defined

    Time frame: Duration of the the treatment period - 12 weeks

    Number of patients having a clinic defined disease exacerbation

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 31, 2009
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.