Clinical trial NCT01054170: Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic
obstructive
pulmonary
lung
respiratory disease
efficacy
placebo-controlled
COPD
FEV1
St Georges Respiratory Questionnaire
Computed Tomography
MSCT
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
timeFrame: Measured after 12 weeks treatment (day 84)
Secondary outcomes:
measure: 5th Generation Wall Area Percentage
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Air Trapping Index (ATI) on Expiratory Scans
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Inspiratory Capacity (IC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Total Lung Capacity (TLC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Functional Residual Capacity (FRC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Residual Volume (RV)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Specific Airway Conductance (SGaw)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Forced Vital Capacity (FVC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Post-bronchodilator Forced Vital Capacity (FVC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Pre-bronchodilator Slow Vital Capacity (SVC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Post-bronchodilator Slow Vital Capacity (SVC)
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Peak Expiratory Flow (PEF) Morning (Daily Recordings)
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: Peak Expiratory Flow (PEF) Evening (Daily Recordings)
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: Breathlessness, Cough and Sputum Scale (BCSS) Total Score
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
timeFrame: Measured after 12 weeks treatment (day 84)
measure: Percentage of Reliever Free Days in Last Six Weeks of Treatment
timeFrame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
measure: Exacerbations
timeFrame: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Quebec
country: Canada
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Odensec
country: Denmark
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
Study officials:
affiliation: Gentofte Hospital, Department of Lung Medicine
name: Professor Asger Dirksen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordenmark LH, Taylor R, Jorup C. Feasibility of Computed Tomography in a Multicenter COPD Trial: A Study of the Effect of AZD9668 on Structural Airway Changes. Adv Ther. 2015 Jun;32(6):548-66. doi: 10.1007/s12325-015-0215-3. Epub 2015 Jun 5.