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Completed

NCT Number: NCT00629239

Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

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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, Hvidovre, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of COPD, with symptoms for more than 1 year
  • Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
  • Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion criteria

  • Clinical suspicion of active tuberculosis
  • Any current clinically significant respiratory tract disorder other than COPD
  • History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina

Treatment and study plan

AZD4818

Drug

Dry Powder, inhalation, b.i.d., 4 weeks

Placebo

Drug

Primary outcomes

  1. Number of Patients Experiencing Adverse Events

    Time frame: At all study visits

    Number of patients who had an Adverse Event

Secondary outcomes

  1. Forced Expiratory Volume 1 (FEV1)

    Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment

    Change in (FEV1) from baseline to end of treatment

  2. Forced Vital Capacity (FVC)

    Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment

    Change in FVC from baseline to end of treatment

  3. Vital Capacity (VC)

    Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment

    Change in VC from baseline to end of treatment

  4. Inspiratory Capacity (IC)

    Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment

    Change from IC baseline to end of treatment

  5. Forced Expiratory Flow (FEF) 25%-75%

    Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment

    Change in FEF from baseline to end of treatment

  6. Peak Expiratory Flow (PEF) Morning

    Time frame: Daily during run-in and treatment

    Change from average during run-in to average during treatment

  7. Peak Expiratory Flow (PEF) Evening

    Time frame: Daily during run-in and treatment

    Change in PEF from average during run-in to average during treatment

  8. The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total

    Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment

    Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

  9. Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness

    Time frame: Daily during run-in and treatment

    Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

  10. Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness

    Time frame: Daily during run-in and treatment

    Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

  11. Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score

    Time frame: Daily during run-in and treatment

    Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

  12. Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score

    Time frame: Daily during run-in and treatment

    Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

  13. 6-minute Walk Test

    Time frame: Before treatment and after 4 weeks of treatment

    Change from baseline to end of treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Acronym: TOP

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2008
Registry last updated
Dec 6, 2010

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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