The study will evaluate the effect of AZD9164 in patients with Chronic Obstructive Pulmonary Disease - LaCrossE

Study identifier:D1882C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A double-blind, double-dummy, placebo-controlled, randomised, multi-centre, 5-way cross-over, single-dose study to investigate the local and systemic effects of inhaled AZD9164 compared to tiotropium in subjects with Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 2

Healthy volunteers

Study drug

AZD9164, Tiotropium, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Jun 2009

Primary Completion Date: 01 Nov 2009

Study Completion Date: 01 Nov 2009

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2011 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Lulea, Sweden

Location

Research Site

Lund, Sweden

Arms	Assigned Interventions
Experimental: AZD9164 100 mcg First, then Placebo for Spririva 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation	Drug: AZD9164 Solution for inhalation through nebulization, single dose Drug: Placebo Placebo
Experimental: AZD9164 400 mcg First, then Placebo for Spiriva 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation	Drug: AZD9164 Solution for inhalation through nebulization, single dose Drug: Placebo Placebo
Experimental: AZD9164 1200 mcg First, then Placebo for Spiriva 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation	Drug: AZD9164 Solution for inhalation through nebulization, single dose Drug: Placebo Placebo
Active Comparator: Spiriva 18 mcg First, then Placebo for AZD9164 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)	Drug: Tiotropium Dry powder for inhalation, single dose Other Name: Spiriva Drug: Placebo Placebo
Placebo Comparator: Placebo for Spiriva First, then Placebo for AZD9164 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)	Drug: Placebo Placebo

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=301&filename=CSR-D1882C00003.pdf
Download
CSR-D1882C00003.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Leif Bjermer

University Hospital in Lund, Sweden

The study will evaluate the effect of AZD9164 in patients with Chronic Obstructive Pulmonary Disease - LaCrossE

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=301&filename=CSR-D1882C00003.pdf

CSR-D1882C00003.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator