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The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease (LaCrossE)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

AZD9164

Tiotropium

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease (COPD), efficacy, safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A clinical diagnosis of COPD
FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

Any clinically relevant abnormal findings at screening examinations
Any clinically significant disease or disorder

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

AZD9164 100 mcg First, then Placebo for Spririva

AZD9164 400 mcg First, then Placebo for Spiriva

AZD9164 1200 mcg First, then Placebo for Spiriva

Spiriva 18 mcg First, then Placebo for AZD9164

Placebo for Spiriva First, then Placebo for AZD9164

Arm Description

1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)

1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose

Maximum FEV1 value

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose

Trough FEV1 value

Secondary Outcome Measures

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose

Average FEV1 value

Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose

15 min FEV1 value

Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Average systolic blood pressure value

Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Average diastolic blood pressure value

Pulse, Average Effect Over 0 - 4 Hours Post-dose

Average pulse value

Heart Rate, Average Effect Over 0 - 4 Hours Post-dose

Average heart rate value

QTcF, Average Effect Over 0 - 4 Hours Post-dose

Average QTcF value

Plasma AZD9164 Cmax

Maximum plasma concentration of AZD9164

Plasma AZD9164 AUC0-24

Area under the AZD9164 plasma concentration curve

Full Information

NCT ID

NCT00939211

First Posted

July 13, 2009

Last Updated

July 8, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00939211

Brief Title

The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease

Acronym

LaCrossE

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AZD9164 100 mcg First, then Placebo for Spririva

Arm Type

Experimental

Arm Description

1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Arm Title

AZD9164 400 mcg First, then Placebo for Spiriva

Arm Type

Experimental

Arm Description

1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Arm Title

AZD9164 1200 mcg First, then Placebo for Spiriva

Arm Type

Experimental

Arm Description

1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Arm Title

Spiriva 18 mcg First, then Placebo for AZD9164

Arm Type

Active Comparator

Arm Description

1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)

Arm Title

Placebo for Spiriva First, then Placebo for AZD9164

Arm Type

Placebo Comparator

Arm Description

1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)

Intervention Type

Drug

Intervention Name(s)

AZD9164

Intervention Description

Solution for inhalation through nebulization, single dose

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Other Intervention Name(s)

Spiriva

Intervention Description

Dry powder for inhalation, single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose

Description

Maximum FEV1 value

Time Frame

0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Title

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose

Description

Trough FEV1 value

Time Frame

22 h, 24 h, 26 h

Secondary Outcome Measure Information:

Title

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose

Description

Average FEV1 value

Time Frame

0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Title

Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose

Description

15 min FEV1 value

Time Frame

15 min

Title

Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Description

Average systolic blood pressure value

Time Frame

0, 30 min, 2 h, 4 h

Title

Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Description

Average diastolic blood pressure value

Time Frame

0, 30 min, 2 h, 4 h

Title

Pulse, Average Effect Over 0 - 4 Hours Post-dose

Description

Average pulse value

Time Frame

0, 30 min, 2 h, 4 h

Title

Heart Rate, Average Effect Over 0 - 4 Hours Post-dose

Description

Average heart rate value

Time Frame

0, 30 min, 2 h, 4 h

Title

QTcF, Average Effect Over 0 - 4 Hours Post-dose

Description

Average QTcF value

Time Frame

0, 30 min, 2 h, 4 h

Title

Plasma AZD9164 Cmax

Description

Maximum plasma concentration of AZD9164

Time Frame

0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

Title

Plasma AZD9164 AUC0-24

Description

Area under the AZD9164 plasma concentration curve

Time Frame

0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A clinical diagnosis of COPD FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70% Exclusion Criteria: Any clinically relevant abnormal findings at screening examinations Any clinically significant disease or disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leif Bjermer, Prof, MD, PhD

Organizational Affiliation

University Hospital in Lund, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Gothenburg

Country

Sweden

Facility Name

Research Site

City

Lulea

Country

Sweden

Facility Name

Research Site

City

Lund

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

23098686

Citation

Bjermer L, Bengtsson T, Jorup C, Lotvall J. Local and systemic effects of inhaled AZD9164 compared with tiotropium in patients with COPD. Respir Med. 2013 Jan;107(1):84-90. doi: 10.1016/j.rmed.2012.09.014. Epub 2012 Oct 23.

Results Reference

derived

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The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease

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