Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A 12-week, Phase II, Double-blind, Placebo-Controlled, Randomised, Parallel-Group, Multi-Centre Study to Assess the Effect of 60mg AZD9668 Administered Orally Twice Daily on Structural Changes in the Airways by Multi-Slice Computed Tomography in Patients With Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054170
• Other study ID #: D0520C00014
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2010
• Last updated: August 14, 2012
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaDenmark: Danish Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Romania: National Medicines AgencyUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of COPD with symptoms over 1 year

• FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator

• Ex-smokers for at least 12 months

Exclusion Criteria:

• Past history or current evidence of clinically significant heart disease

• Current diagnosis of asthma

• Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
• Placebo
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks

Locations

Country	Name	City	State
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Quebec
Denmark	Research Site	Hellerup
Denmark	Research Site	Hvidovre
Denmark	Research Site	Odensec
Netherlands	Research Site	Breda
Netherlands	Research Site	Nieuwegein
Romania	Research Site	Bucuresti
Ukraine	Research Site	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Denmark,  Netherlands,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)	AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	5th Generation Wall Area Percentage	5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Air Trapping Index (ATI) on Expiratory Scans	ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Inspiratory Capacity (IC)	Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Total Lung Capacity (TLC)	Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Functional Residual Capacity (FRC)	Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Residual Volume (RV)	Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Specific Airway Conductance (SGaw)	Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)	Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).	Measured after 12 weeks treatment (day 84)	No
Secondary	Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Forced Vital Capacity (FVC)	Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).	Measured after 12 weeks treatment (day 84)	No
Secondary	Post-bronchodilator Forced Vital Capacity (FVC)	Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).	Measured after 12 weeks treatment (day 84)	No
Secondary	Pre-bronchodilator Slow Vital Capacity (SVC)	Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).	Measured after 12 weeks treatment (day 84)	No
Secondary	Post-bronchodilator Slow Vital Capacity (SVC)	Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).	Measured after 12 weeks treatment (day 84)	No
Secondary	Peak Expiratory Flow (PEF) Morning (Daily Recordings)	Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	Peak Expiratory Flow (PEF) Evening (Daily Recordings)	Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)	Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	Breathlessness, Cough and Sputum Scale (BCSS) 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).	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) 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).	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) 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)).	Measured after 12 weeks treatment (day 84)	No
Secondary	Percentage of Reliever Free Days in Last Six Weeks of Treatment	Percentage of reliever free days in last 6 weeks on treatment.	Average from measurements recorded daily by patient in last 6 weeks of treatment.	No
Secondary	Exacerbations	Number of patients experiencing disease exacerbations on treatment.	Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)	No