NCT01054170

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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 25, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

10 months

First QC Date

January 20, 2010

Results QC Date

January 24, 2012

Last Update Submit

August 14, 2012

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronicobstructivepulmonarylungrespiratory diseaseefficacyplacebo-controlledCOPDFEV1St Georges Respiratory QuestionnaireComputed TomographyMSCT

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (23)

  • 5th Generation Wall Area Percentage

    Measured after 12 weeks treatment (day 84)

  • Air Trapping Index (ATI) on Expiratory Scans

    Measured after 12 weeks treatment (day 84)

  • Pre-bronchodilator Inspiratory Capacity (IC)

    Measured after 12 weeks treatment (day 84)

  • Pre-bronchodilator Total Lung Capacity (TLC)

    Measured after 12 weeks treatment (day 84)

  • Pre-bronchodilator Functional Residual Capacity (FRC)

    Measured after 12 weeks treatment (day 84)

  • +18 more secondary outcomes

Study Arms (2)

AZD9668

EXPERIMENTAL
Drug: AZD9668

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD9668DRUG

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

AZD9668
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Kingston, Ontario, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Hellerup, Denmark

Location

Research Site

Hvidovre, Denmark

Location

Research Site

Odensec, Denmark

Location

Research Site

Breda, Netherlands

Location

Research Site

Nieuwegein, Netherlands

Location

Research Site

Bucharest, Romania

Location

Research Site

Kyiv, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 26043724DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchiolitis Obliterans SyndromeRespiration Disorders

Interventions

N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesGraft vs Host DiseaseImmune System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Professor Asger Dirksen

    Gentofte Hospital, Department of Lung Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 20, 2012

Results First Posted

July 25, 2012

Record last verified: 2012-08

Locations

RO(1)CA(2)UA(1)DK(3)NL(2)