NCT00758459

Brief Summary

The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2008

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

Geographic Reach
5 countries

14 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
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 19, 2011

Completed
Last Updated

August 19, 2011

Status Verified

July 1, 2011

First QC Date

September 23, 2008

Results QC Date

July 25, 2011

Last Update Submit

July 25, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Number of patients who had an Adverse Event

    all study visits

Secondary Outcomes (13)

  • Forced Expiratory Volume in 1 Second (FEV1)

    Before treatment and after 1, 2, 4 and 6 weeks of treatment

  • Forced Vital Capacity (FVC)

    Before treatment and after 1, 2, 4 and 6 weeks of treatment

  • Vital Capacity (VC)

    Before treatment and after 1, 2, 4 and 6 weeks of treatment

  • Inspiratory Capacity (IC)

    Before treatment and after 1, 2, 4 and 6 weeks of treatment

  • Forced Expiratory Flow (FEF)25-75%

    Before treatment and after 1, 2, 4 and 6 weeks of treatment

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD1236

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1236DRUG

oral tablet, 75 mg, twice daily during 6 weeks

1
PlaceboDRUG

Dosing to match AZD1236

2

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 reduced lung function
  • 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
  • Use of oral or parenteral glucocorticosteroids within 30 days prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Rousse, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Helsinki, Finland

Location

Research Site

Oulu, Finland

Location

Research Site

Preitilä, Finland

Location

Research Site

Berlin, Germany

Location

Research Site

Grobhansdorf, Germany

Location

Research Site

Győr, Hungary

Location

Research Site

Komló, Hungary

Location

Research Site

Pécs, Hungary

Location

Research Site

Vásárosnamény, Hungary

Location

Research Site

Bojnice, Slovakia

Location

Research Site

Liptovský Hrádok, Slovakia

Location

Research Site

Žilina, Slovakia

Location

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
aztrial_results_posting@astrazeneca.com

Study Officials

  • Helgo Magnussen, MD, Professor

    Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany

    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

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

September 1, 2008

Study Completion

March 1, 2009

Last Updated

August 19, 2011

Results First Posted

August 19, 2011

Record last verified: 2011-07

Locations

BU(2)HU(4)SL(3)DE(2)FI(3)