NCT00758706

Brief Summary

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
4 countries

10 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

September 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6 years until next milestone

Results Posted

Study results publicly available

April 16, 2015

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

September 23, 2008

Results QC Date

July 25, 2011

Last Update Submit

April 14, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (3)

  • Ratio of TNF Alpha at Week 6 to Baseline

    Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

    Baseline and Week 6

  • Ratio of Sputum Total Cells at Week 6 to Baseline

    Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

    Baseline and Week 6

  • Ratio of Total Urine Desmosine at Week 6 to Baseline

    Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

    Baseline and Week 6

Secondary Outcomes (13)

  • Incidence of Adverse Events

    all study visits

  • Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6

    Baseline and Week 6

  • Change From Baseline in Forced Vital Capacity (FVC) at Week 6

    Baseline and Week 6

  • Change From Baseline in Vital Capacity (VC) at Week 6

    Baseline and Week 6

  • Change From Baseline in Inspiratory Capacity (IC) at Week 6

    Baseline and Week 6

  • +8 more secondary outcomes

Study Arms (2)

AZD1236

EXPERIMENTAL

oral tablet, 75 mg, twice daily during 6 weeks

Drug: AZD1236

Placebo

PLACEBO COMPARATOR

Dosing to match AZD1236

Drug: Placebo

Interventions

AZD1236DRUG

oral tablet, 75 mg, twice daily during 6 weeks

AZD1236
PlaceboDRUG

Dosing to match AZD1236

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD for 1 month
  • Men or postmenopausal women
  • Spirometry values indicating symptomatic patients
  • Smoking history equivalent to using 20 cigarettes a day for 10 years.

You may not qualify if:

  • Any current respiratory tract disorders other than COPD
  • Requirement for regular oxygen therapy
  • Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
  • Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Aalborg, Denmark

Location

Research Site

Arhus C, Denmark

Location

Research Site

København NV, Denmark

Location

Research Site

Odense C, Denmark

Location

Research Site

Helsinki, Finland

Location

Research Site

Tampere, Finland

Location

Research Site

Eindhoven, Netherlands

Location

Research Site

Nieuwegein, Netherlands

Location

Research Site

Oslo, Norway

Location

Research Site

Trondheim, Norway

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Ronald Dahl, MD, Professor

    Arhus Kommune HospitalMedicinsk

    PRINCIPAL INVESTIGATOR

  • Andrew Lockton, MD

    AstraZeneca R&D Charnwood

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 16, 2015

Results First Posted

April 16, 2015

Record last verified: 2015-04

Locations

DK(4)NO(2)NL(2)FI(2)