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

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: AZD4818

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Research Site
  • København Nv, Denmark
    • Research Site
  • Odense C, Denmark
    • Research Site
• Finland
  • Helsinki, Finland
    • Research Site
  • Preitilä, Finland
    • Research Site
  • Tampere, Finland
    • Research Site
• Netherlands
  • Breda, Netherlands
    • Research Site
  • Groningen, Netherlands
    • Research Site
• Norway
  • Elverum, Norway
    • Research Site
  • Oslo, Norway
    • Research Site
  • Trondheim, Norway
    • Research Site
• Sweden
  • Lund, Sweden
    • Research Site

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo
Experimental: 1; AZD4818	Drug: AZD4818; Dry Powder, inhalation, b.i.d., 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Experiencing Adverse Events	Number of patients who had an Adverse Event	At all study visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume 1 (FEV1)	Change in (FEV1) from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Vital Capacity (FVC)	Change in FVC from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment
Vital Capacity (VC)	Change in VC from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment
Inspiratory Capacity (IC)	Change from IC baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Expiratory Flow (FEF) 25%-75%	Change in FEF from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment
Peak Expiratory Flow (PEF) Morning	Change from average during run-in to average during treatment	Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening	Change in PEF from average during run-in to average during treatment	Daily during run-in and treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total	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)	Before treatment and after 1, 2, 3 and 4 weeks of treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	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).	Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	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).	Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	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).	Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score	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).	Daily during run-in and treatment
6-minute Walk Test	Change from baseline to end of treatment	Before treatment and after 4 weeks of treatment

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Huib AM Kerstjens, MD, PhD, University Medical Centre, Groningen, The Netherlands

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: February 25, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): December 6, 2010
• Last Update Submitted That Met QC Criteria: November 4, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: tolerability; COPD; inhalation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D3540C00005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No