Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00629239
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : December 6, 2010
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: AZD4818 Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Patients Experiencing Adverse Events [ Time Frame: At all study visits ]
    Number of patients who had an Adverse Event


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629239


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Huib AM Kerstjens, MD, PhD University Medical Centre, Groningen, The Netherlands
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bengt Larsson/MD PhD Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00629239    
Other Study ID Numbers: D3540C00005
First Posted: March 5, 2008    Key Record Dates
Results First Posted: December 6, 2010
Last Update Posted: December 6, 2010
Last Verified: November 2010
Keywords provided by AstraZeneca:
COPD
tolerability
inhalation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases