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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01054170

Purpose

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)

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, 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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) CT Scans

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

AWT-Pi10 (airway wall thickness of a theoretical airway with an internal perimeter of 10 mm) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

5th generation wall area percentage [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Air Trapping Index (ATI) on expiratory scans [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Total Lung Capacity (TLC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Functional Residual Capacity (FRC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Inspiratory Capacity (IC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Residual Volume (RV) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Specific Airway Conductance (SGaw) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Forced Vital Capacity (FVC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Pre-bronchodilator Slow Vital Capacity (SVC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Peak Expiratory Flow (PEF) morning [ Time Frame: Daily by last 6 weeks of treatment ] [ Designated as safety issue: No ]
Peak Expiratory Flow (PEF) evenings [ Time Frame: Daily by last 6 weeks of treatment ] [ Designated as safety issue: No ]
Forced Expiratory Volume in 1 second (FEV1) morning [ Time Frame: Daily by last 6 weeks of treatment ] [ Designated as safety issue: No ]
Forced Expiratory Volume in 1 second (FEV1) evenings [ Time Frame: Daily by last 6 weeks of treatment ] [ Designated as safety issue: No ]
Breathlessness, Cough and Sputum Scale (BCSS) total score [ Time Frame: Daily by last 6 weeks of treatment ] [ Designated as safety issue: No ]
Exacerbations of Chronic Pulmonary disease Tool (EXACT) total score [ Time Frame: Daily by last 6 weeks of treatment ] [ Designated as safety issue: No ]
St George's Respiratory Questionnaire for COPD patients (SGRQ-C) overall score [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Percentage of reliever free days [ Time Frame: Last 6 weeks of treatment ] [ Designated as safety issue: No ]
Number of patients experiencing at least one exacerbation [ Time Frame: At all study visits (after 1, 4, 8, and 12 weeks of treatment and at folllow up) ] [ Designated as safety issue: No ]
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Post-bronchodilator Forced Vital Capacity (FVC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Post-bronchodilator Slow Vital Capacity (SVC) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Enrollment:	109
Study Start Date:	January 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 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:	50 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 >= 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054170

Locations

Canada, Ontario
Research Site
Kingston, Ontario, Canada
Canada
Research Site
Quebec, Canada
Denmark
Research Site
Hellerup, Denmark
Research Site
Hvidovre, Denmark
Research Site
Odensec, Denmark
Netherlands
Research Site
Breda, Netherlands
Research Site
Nieuwegein, Netherlands
Romania
Research Site
Bucuresti, Romania
Ukraine
Research Site
Kyiv, Ukraine

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Professor Asger Dirksen

Gentofte Hospital, Department of Lung Medicine

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01054170 History of Changes
Other Study ID Numbers:	D0520C00014
Study First Received:	January 20, 2010
Last Updated:	November 15, 2011
Health Authority:	Canada: Health Canada Denmark: Danish Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Romania: National Medicines Agency Ukraine: Ministry of Health

Keywords provided by AstraZeneca:

Chronic
obstructive
pulmonary
lung
respiratory disease
efficacy

placebo-controlled
COPD
FEV1
St Georges Respiratory Questionnaire
Computed Tomography
MSCT

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012