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OpenTrials
Completed

NCT Number: NCT01023516

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) 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, Lovech, Bulgaria

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
  • 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

Treatment and study plan

AZD9668

Drug

2 x 30 mg oral tablets bd for 12 weeks

Placebo

Drug

2 x matched placebo to oral tablet bd for 12 weeks

Primary outcomes

  1. Baseline Pre-bronchodilator FEV1 (L)

    Time frame: Day 1

    Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

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

    Time frame: up to week 12

    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 (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

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

    Time frame: up to week 12

    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 (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

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

    Time frame: up to week 12

    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 (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

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

    Time frame: up to week 12

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

  7. Baseline Pre-bronchodilator FEV6 (L)

    Time frame: Day 1

    Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

  8. End-value Pre-bronchodilator FEV6 (L)

    Time frame: up to week 12

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

  9. Baseline Post-bronchodilator FEV6 (L)

    Time frame: Day 1

    Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.

  10. End-value Post-bronchodilator FEV6 (L)

    Time frame: up to week 12

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

  11. Baseline Pre-bronchodilator FEF25-75% (L/Sec)

    Time frame: Day 1

    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.

  12. End-value Pre-bronchodilator FEF25-75% (L/Sec)

    Time frame: up to week 12

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

  13. Baseline Post-bronchodilator FEF25-75% (L/Sec)

    Time frame: Day 1

    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.

  14. End-value Post-bronchodilator FEF25-75% (L/Sec)

    Time frame: up to week 12

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

  15. Pre-bronchodilator IC (L) - Baseline

    Time frame: Day 1

    Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

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

    Time frame: up to week 12

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

  17. Post-bronchodilator IC (L) - Baseline

    Time frame: Day 1

    Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.

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

    Time frame: up to week 12

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

  19. 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.

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

    Time frame: Last 6 weeks on treatment

    Peak expiratory flow (PEF)

  21. 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.

  22. 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)

  23. 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.

  24. EXACT - End-value Total Score

    Time frame: Last 6 weeks on treatment

    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).

  25. 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.

  26. BCSS - End-value Total Score

    Time frame: Last 6 weeks on treatment

    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).

  27. 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).

  28. Sputum Colour - End Value

    Time frame: End of treatment week 12

    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

  29. Use of Reliever Medication

    Time frame: Last 6 weeks on treatment

    Daily average of number of inhalations of reliever medication

  30. Incremental Shuttle Walk Test - Baseline

    Time frame: Day 1

    Endurance time (s)

  31. Incremental Shuttle Walk Test - End Value

    Time frame: Week 12 - visit 6

  32. Endurance Shuttle Walk Test - Baseline

    Time frame: Day 1

    Endurance time (s)

  33. Endurance Shuttle Walk Test - End Value

    Time frame: Week 12 - visit 6

    Assessed at vist 6 -( last on treatment clinic visit)

  34. 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)).

  35. 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)

  36. 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 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 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.

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