Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00629239

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: AZD4818 Drug: Placebo	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 4-Week Double-Blind, Placebo-Controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Incidence and nature of adverse events [ Time Frame: Once weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lung function [ Time Frame: Once weekly ] [ Designated as safety issue: No ]
Symptoms [ Time Frame: Once weekly ] [ Designated as safety issue: No ]
6-minute walk test [ Time Frame: Once weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD4818	Drug: AZD4818 Dry Powder, inhalation, b.i.d., 4 weeks
2: Placebo Comparator Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629239

Locations

Denmark
Research Site
Hvidovre, Denmark
Research Site
KØBENHAVN NV, Denmark
Research Site
ODENSE C, Denmark
Finland
Research Site
TAMPERE, Finland
Research Site
PREITILÄ, Finland
Research Site
HELSINKI, Finland
Netherlands
Research Site
BREDA, Netherlands
Research Site
GRONINGEN, Netherlands
Norway
Research Site
ELVERUM, Norway
Research Site
OSLO, Norway
Research Site
TRONDHEIM, Norway
Sweden
Research Site
LUND, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Huib AM Kerstjens, MD, PhD

University Medical Centre, Groningen, The Netherlands

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Bengt Larsson/MD PhD Medical Science Director )
Study ID Numbers:	D3540C00005
Study First Received:	February 25, 2008
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00629239
Health Authority:	Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by AstraZeneca:

COPD
tolerability
inhalation

Study placed in the following topic categories:

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

ClinicalTrials.gov processed this record on January 16, 2009