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NCT Number: NCT00939211

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9164

Drug

Solution for inhalation through nebulization, single dose

Tiotropium

Drug

Dry powder for inhalation, single dose

Other names: Spiriva

Placebo

Drug

Placebo

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

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

    Time frame: 15 min

    15 min FEV1 value

  3. 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

  4. 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

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

    Time frame: 0, 30 min, 2 h, 4 h

    Average pulse value

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

    Time frame: 0, 30 min, 2 h, 4 h

    Average heart rate value

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

    Time frame: 0, 30 min, 2 h, 4 h

    Average QTcF value

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: LaCrossE

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2009
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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