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

AstraZeneca838 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

838

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

AZD9668DRUG

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

AZD9668DRUG

2 x 10 mg oral tablets twice daily (bid) for 12 weeks

AZD9668DRUG

2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks

AZD9668 Placebo

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (105)

Outcomes

Primary Outcomes

Baseline Pre-bronchodilator FEV1 (L)

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

Time frame: Day 1

End-value Pre-bronchodilator FEV1 (L)

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

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

Secondary Outcomes

Post-bronchodilator FEV1 (L) - Baseline

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

Time frame: Day 1

Post-bronchodilator FEV1 (L) - End-value

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

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

Pre-bronchodilator FVC (L) - Baseline

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

Time frame: Day 1

Pre-bronchodilator FVC (L) - End-value

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

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

Post-bronchodilator FVC (L) - Baseline

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

Data from ClinicalTrials.gov

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

Research Site

Fullerton, California, United States

Research Site

Valparaiso, Indiana, United States

Research Site

Council Bluffs, Iowa, United States

Research Site

Hickory, North Carolina, United States

Research Site

Jefferson Hills, Pennsylvania, United States

Research Site

Gaffney, South Carolina, United States

Research Site

Greenville, South Carolina, United States

Research Site

Spartanburg, South Carolina, United States

Research Site

Boerne, Texas, United States

Research Site

Concord, New South Wales, Australia

...and 95 more locations

Post-bronchodilator FVC (L) - End-value

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

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

Pre-bronchodilator IC (L) - Baseline

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

Time frame: Day 1

Pre-bronchodilator IC (L) - End-value

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

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

Post-bronchodilator IC (L) - Baseline

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

Time frame: Day 1

Post-bronchodilator IC (L) - End-value

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

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

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

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

Time frame: Baseline

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

Peak Expiratory Flow (L/min)

Time frame: Last 6 weeks on treatment

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

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

Time frame: Baseline

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

Forced Expiratory Volume in 1 second (L)

Time frame: Last 6 weeks on treatment

EXACT - Baseline Total Score

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.

Time frame: Baseline

EXACT - End-value Total Score

Time frame: Measured daily in the evening for 12 weeks

BCSS - Baseline Total Score

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

Time frame: Baseline

BCSS - End-value Total Score

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

Time frame: Measured daily in the evening for 12 weeks

Sputum Colour - 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).

Time frame: Baseline

Sputum Colour - End Value

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

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

Use of Reliever Medication

Daily average of number of inhalations of reliever medication

Time frame: Last 6 weeks on treatment

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

Time frame: Day 1

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

distance walked on vist 6 - last on treatment clinic visit

Time frame: Measured Day 1 and 12 weeks

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

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)).

Time frame: Day 1

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

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)

Time frame: Measured Day 1 and 12 weeks

Exacerbations - Clinic Defined

Number of patients having a clinic defined disease exacerbation

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