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

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ClinicalTrials.gov Identifier: NCT01023516
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 2, 2009
Results First Submitted Date  ICMJE January 24, 2012
Results First Posted Date  ICMJE August 3, 2012
Last Update Posted Date August 3, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
  • 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.
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Pre-bronchodilator FEV1 at clinic visits [ Time Frame: Variables will be measured at 1 week, 4 weeks, 8 weeks and 12 weeks. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • PEF - End-value Measured by Patient at Home (L/Min) in the Morning [ Time Frame: Last 6 weeks on treatment ]
    Peak expiratory flow (PEF)
  • 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.
  • 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)
  • 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.
  • 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).
  • 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.
  • 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).
  • 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).
  • 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
  • Use of Reliever Medication [ Time Frame: Last 6 weeks on treatment ]
    Daily average of number of inhalations of reliever medication
  • Incremental Shuttle Walk Test - Baseline [ Time Frame: Day 1 ]
    Endurance time (s)
  • Incremental Shuttle Walk Test - End Value [ Time Frame: Week 12 - visit 6 ]
  • Endurance Shuttle Walk Test - Baseline [ Time Frame: Day 1 ]
    Endurance time (s)
  • Endurance Shuttle Walk Test - End Value [ Time Frame: Week 12 - visit 6 ]
    Assessed at vist 6 -( last on treatment clinic visit)
  • 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)).
  • 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)
  • Exacerbations - Clinic Defined [ Time Frame: Duration of the the treatment period - 12 weeks ]
    Number of patients having a clinic defined disease exacerbation.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • Lung function including FEV1 (post-bronchodilator) FVC, FEV6, FEF25-75%, IC and home PEF and FEV1 recordings. [ Time Frame: Variables will be measured at 1 week, 4 weeks, 8 weeks and 12 weeks or at home throughout the study where appropriate. ]
  • Signs and symptoms including Patient Reported Outcome tools, symptom scores, COPD exacerbations and use of reliever medication. [ Time Frame: Variables will be measured at 1 week, 4 weeks, 8 weeks and 12 weeks or at home throughout the study where appropriate. ]
  • Exercise capacity; Health Related Quality of Life; Safety and Tolerability: Serious Adverse Events, Adverse Events [ Time Frame: Variables will be measured at 1 week, 4 weeks, 8 weeks and 12 weeks or at home throughout the study where appropriate. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: AZD9668
    2 x 30 mg oral tablets bd for 12 weeks
  • Drug: Placebo
    2 x matched placebo to oral tablet bd for 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: AZD9668
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2012)
615
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
600
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czech Republic,   Hungary,   Poland,   Romania,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023516
Other Study ID Numbers  ICMJE D0520C00020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Piotr Kuna, Professor Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
PRS Account AstraZeneca
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP