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

July 8, 2011 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Research Site
      • Lulea, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Placebo
Placebo
Drug: AZD9164
Solution for inhalation through nebulization, single dose
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: Placebo
Placebo
Drug: AZD9164
Solution for inhalation through nebulization, single dose
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: Placebo
Placebo
Drug: AZD9164
Solution for inhalation through nebulization, single dose
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: Placebo
Placebo
Drug: Tiotropium
Dry powder for inhalation, single dose
Other Names:
  • Spiriva
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
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
Maximum FEV1 value
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
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
Time Frame: 22 h, 24 h, 26 h
Trough FEV1 value
22 h, 24 h, 26 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose
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
Average FEV1 value
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
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose
Time Frame: 15 min
15 min FEV1 value
15 min
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Time Frame: 0, 30 min, 2 h, 4 h
Average systolic blood pressure value
0, 30 min, 2 h, 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Time Frame: 0, 30 min, 2 h, 4 h
Average diastolic blood pressure value
0, 30 min, 2 h, 4 h
Pulse, Average Effect Over 0 - 4 Hours Post-dose
Time Frame: 0, 30 min, 2 h, 4 h
Average pulse value
0, 30 min, 2 h, 4 h
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
Time Frame: 0, 30 min, 2 h, 4 h
Average heart rate value
0, 30 min, 2 h, 4 h
QTcF, Average Effect Over 0 - 4 Hours Post-dose
Time Frame: 0, 30 min, 2 h, 4 h
Average QTcF value
0, 30 min, 2 h, 4 h
Plasma AZD9164 Cmax
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
Maximum plasma concentration of AZD9164
0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Plasma AZD9164 AUC0-24
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
Area under the AZD9164 plasma concentration curve
0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Leif Bjermer, Prof, MD, PhD, University Hospital in Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (ESTIMATE)

July 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2011

Last Update Submitted That Met QC Criteria

July 8, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1882C00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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