NCT00629239

Brief Summary

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
5 countries

12 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, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 6, 2010

Completed
Last Updated

December 6, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

February 25, 2008

Results QC Date

November 4, 2010

Last Update Submit

November 4, 2010

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDtolerabilityinhalation

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Experiencing Adverse Events

    Number of patients who had an Adverse Event

    At all study visits

Secondary Outcomes (13)

  • Forced Expiratory Volume 1 (FEV1)

    Before treatment and after 1, 2, 3 and 4 weeks of treatment

  • Forced Vital Capacity (FVC)

    Before treatment and after 1, 2, 3 and 4 weeks of treatment

  • Vital Capacity (VC)

    Before treatment and after 1, 2, 3 and 4 weeks of treatment

  • Inspiratory Capacity (IC)

    Before treatment and after 1, 2, 3 and 4 weeks of treatment

  • Forced Expiratory Flow (FEF) 25%-75%

    Before treatment and after 1, 2, 3 and 4 weeks of treatment

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

AZD4818

Drug: AZD4818

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD4818DRUG

Dry Powder, inhalation, b.i.d., 4 weeks

1
PlaceboDRUG
2

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of COPD, with symptoms for more than 1 year
  • Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
  • Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

You may not qualify if:

  • Clinical suspicion of active tuberculosis
  • Any current clinically significant respiratory tract disorder other than COPD
  • History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Hvidovre, Denmark

Location

Research Site

København NV, Denmark

Location

Research Site

Odense C, Denmark

Location

Research Site

Helsinki, Finland

Location

Research Site

Preitilä, Finland

Location

Research Site

Tampere, Finland

Location

Research Site

Breda, Netherlands

Location

Research Site

Groningen, Netherlands

Location

Research Site

Elverum, Norway

Location

Research Site

Oslo, Norway

Location

Research Site

Trondheim, Norway

Location

Research Site

Lund, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Aspiration

Interventions

AZD-4818

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Huib AM Kerstjens, MD, PhD

    University Medical Centre, Groningen, The Netherlands

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

December 6, 2010

Results First Posted

December 6, 2010

Record last verified: 2010-11

Locations

NO(3)NL(2)SE(1)FI(3)DK(3)