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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

February 25, 2008
November 4, 2010
January 2008
June 2008   (final data collection date for primary outcome measure)
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
Incidence and nature of adverse events [ Time Frame: Once weekly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00629239 on ClinicalTrials.gov Archive Site
  • 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
  • Lung function [ Time Frame: Once weekly ] [ Designated as safety issue: No ]
  • Symptoms [ Time Frame: Once weekly ] [ Designated as safety issue: No ]
  • 6-minute walk test [ Time Frame: Once weekly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: AZD4818
    Dry Powder, inhalation, b.i.d., 4 weeks
  • Drug: Placebo
  • Experimental: 1
    AZD4818
    Intervention: Drug: AZD4818
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Netherlands,   Norway,   Sweden
 
NCT00629239
D3540C00005
No
Bengt Larsson/MD PhD Medical Science Director, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Huib AM Kerstjens, MD, PhD University Medical Centre, Groningen, The Netherlands
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP