The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD) (Cricket)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01205269

First received: September 15, 2010

Last updated: May 11, 2011

Last verified: May 2011

History of Changes

Purpose

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: AZD8683 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Drug exposure [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Safety (Adverse events, clinical laboratory variables, physical examination, pulse and blood pressure, ECG, FEV1, FVC) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD8683 50ug	Drug: AZD8683 Dry powder for inhalation, single dose
Experimental: 2 AZD8683 200ug	Drug: AZD8683 Dry powder for inhalation, single dose
Placebo Comparator: 3 Placebo to AZD8683	Drug: Placebo Dry powder for inhalation, single dose

Detailed Description:

A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

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 =40 years Current or ex-smokers FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

Any clinically significant disease or disorder
Any clinically relevant abnormal findings at screening examinations
Family history or presence of glaucoma
Need of long term oxygen therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205269

Locations

Poland
Research Site
Białystok, Poland
Research Site
Bydgoszcz, Poland
Research Site
Proszowice, Poland
Research Site
Łódź, Poland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Carin Jorup, MD

AstraZeneca R&DEmerging

More Information

No publications provided

Responsible Party:	Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01205269 History of Changes
Other Study ID Numbers:	D1883C00004, EudraCT number: 2010-020506-15
Study First Received:	September 15, 2010
Last Updated:	May 11, 2011
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by AstraZeneca:

Chronic Obstructive Pulmonary Disease (COPD)
safety
inhalation
long-acting muscarinic receptor antagonist (LAMA)

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 16, 2013

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