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Completed

NCT Number: NCT01205269

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) 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, Bialystok, Poland

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About this study

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)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of COPD
  • 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

Treatment and study plan

AZD8683, 50 mcg

Drug

Dry powder for inhalation, single dose

Placebo

Drug

Dry powder for inhalation, single dose

AZD8683, 200 mcg

Drug

Dry powder for inhalation, single dose

Primary outcomes

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

    Time frame: 0, 5 min, 15 min, 30 min, 1 h, 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, 5 min, 15 min, 30 min, 1 h, 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 Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose

    Time frame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

    Maximum FVC 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. QTcF = QT interval corrected for heart rate using Fridericia's formula

  8. Plasma AZD8683 Cmax

    Time frame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

    Maximum plasma concentration of AZD8683

  9. Plasma AZD8683 AUC0-24

    Time frame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

    Area under the AZD8683 plasma concentration curve from 0 to 24 hours

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 20, 2010
Registry last updated
Mar 19, 2014

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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