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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01023516
First received: December 1, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: AZD9668
Drug: 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: Treatment
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

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 (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 ] [ 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 (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 ] [ 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 (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 ] [ 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 (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 ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • Baseline Pre-bronchodilator FEV6 (L) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  • Baseline Post-bronchodilator FEV6 (L) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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 (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 ] [ 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 (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 ] [ 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 (PEF)

  • 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: Last 6 weeks on treatment ] [ 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).

  • 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: Last 6 weeks on treatment ] [ 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).

  • 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: End of treatment week 12 ] [ 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

  • Incremental Shuttle Walk Test - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Endurance time (s)

  • Incremental Shuttle Walk Test - End Value [ Time Frame: Week 12 - visit 6 ] [ Designated as safety issue: No ]
  • Endurance Shuttle Walk Test - Baseline [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Endurance time (s)

  • Endurance Shuttle Walk Test - End Value [ Time Frame: Week 12 - visit 6 ] [ Designated as safety issue: No ]
    Assessed at 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: 615
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD9668
2 x 30 mg oral tablets bd for 12 weeks
Placebo Comparator: 2 Drug: Placebo
2 x matched placebo to oral tablet bd 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
  • 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
  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: NCT01023516

  Show 67 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Piotr Kuna, Professor Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
  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: NCT01023516     History of Changes
Other Study ID Numbers: D0520C00020
Study First Received: December 1, 2009
Results First Received: January 24, 2012
Last Updated: June 19, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control

Keywords provided by AstraZeneca:
Chronic
obstructive
pulmonary
lung
respiratory disease
efficacy
placebo-controlled
COPD
FEV1
St Georges Respiratory Questionnaire

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Budesonide
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 16, 2014