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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00629239
First received: February 25, 2008
Last updated: November 4, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: AZD4818
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Patients Experiencing Adverse Events [ Time Frame: At all study visits ] [ Designated as safety issue: No ]
    Number of patients who had an Adverse Event


Secondary Outcome Measures:
  • Forced Expiratory Volume 1 (FEV1) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Change in (FEV1) from baseline to end of treatment

  • Forced Vital Capacity (FVC) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Change in FVC from baseline to end of treatment

  • Vital Capacity (VC) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Change in VC from baseline to end of treatment

  • Inspiratory Capacity (IC) [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Change from IC baseline to end of treatment

  • Forced Expiratory Flow (FEF) 25%-75% [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]
    Change in FEF from baseline to end of treatment

  • Peak Expiratory Flow (PEF) Morning [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    Change from average during run-in to average during treatment

  • Peak Expiratory Flow (PEF) Evening [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    Change in PEF from average during run-in to average during treatment

  • The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]
    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)

  • Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    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).

  • Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    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).

  • Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    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).

  • Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score [ Time Frame: Daily during run-in and treatment ] [ Designated as safety issue: No ]
    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).

  • 6-minute Walk Test [ Time Frame: Before treatment and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    Change from baseline to end of treatment


Enrollment: 65
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD4818
 Drug: AZD4818
Dry Powder, inhalation, b.i.d., 4 weeks
Placebo Comparator: 2
Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629239

Locations
Denmark
Research Site
Hvidovre, Denmark
Research Site
København Nv, Denmark
Research Site
Odense C, Denmark
Finland
Research Site
Helsinki, Finland
Research Site
Preitilä, Finland
Research Site
Tampere, Finland
Netherlands
Research Site
Breda, Netherlands
Research Site
Groningen, Netherlands
Norway
Research Site
Elverum, Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Huib AM Kerstjens, MD, PhD University Medical Centre, Groningen, The Netherlands
  More Information

No publications provided

Responsible Party: Bengt Larsson/MD PhD Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00629239     History of Changes
Other Study ID Numbers: D3540C00005
Study First Received: February 25, 2008
Results First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by AstraZeneca:
COPD
tolerability
inhalation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013