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The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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: NCT01205269
Recruitment Status : Completed
First Posted : September 20, 2010
Results First Posted : November 13, 2013
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: AZD8683, 50 mcg Drug: Placebo Drug: AZD8683, 200 mcg Phase 2

Detailed Description:
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : October 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: First 50 mcg, then 200 mcg, then placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
Drug: AZD8683, 50 mcg
Dry powder for inhalation, single dose
Drug: Placebo
Dry powder for inhalation, single dose
Drug: AZD8683, 200 mcg
Dry powder for inhalation, single dose
Experimental: First 50 mcg, then placebo, then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
Drug: AZD8683, 50 mcg
Dry powder for inhalation, single dose
Drug: Placebo
Dry powder for inhalation, single dose
Drug: AZD8683, 200 mcg
Dry powder for inhalation, single dose
Experimental: First 200 mcg, then placebo, then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
Drug: AZD8683, 50 mcg
Dry powder for inhalation, single dose
Drug: Placebo
Dry powder for inhalation, single dose
Drug: AZD8683, 200 mcg
Dry powder for inhalation, single dose
Experimental: First 200 mcg, then 50 mcg, then placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
Drug: AZD8683, 50 mcg
Dry powder for inhalation, single dose
Drug: Placebo
Dry powder for inhalation, single dose
Drug: AZD8683, 200 mcg
Dry powder for inhalation, single dose
Experimental: First placebo, then 200 mcg, then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
Drug: AZD8683, 50 mcg
Dry powder for inhalation, single dose
Drug: Placebo
Dry powder for inhalation, single dose
Drug: AZD8683, 200 mcg
Dry powder for inhalation, single dose
Experimental: First placebo, then 50 mcg, then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
Drug: AZD8683, 50 mcg
Dry powder for inhalation, single dose
Drug: Placebo
Dry powder for inhalation, single dose
Drug: AZD8683, 200 mcg
Dry powder for inhalation, single dose


Outcome Measures

Primary Outcome Measures :
  1. Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose [ Time Frame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h ]
    Maximum FEV1 value

  2. Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose [ Time Frame: 22 h, 24 h, 26 h ]
    Trough FEV1 value


Secondary Outcome Measures :
  1. Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose [ Time Frame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h ]
    Average FEV1 value

  2. Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose [ Time Frame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h ]
    Maximum FVC value

  3. Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ]
    Average systolic blood pressure value

  4. Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ]
    Average diastolic blood pressure value

  5. Pulse, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ]
    Average pulse value

  6. Heart Rate, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ]
    Average heart rate value

  7. QTcF, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ]
    Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula

  8. Plasma AZD8683 Cmax [ Time Frame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h ]
    Maximum plasma concentration of AZD8683

  9. Plasma AZD8683 AUC0-24 [ Time Frame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h ]
    Area under the AZD8683 plasma concentration curve from 0 to 24 hours


Eligibility Criteria

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.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD
  • Current or ex-smokers
  • FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings at screening examinations
  • Family history or presence of glaucoma
  • Need of long term oxygen therapy
Contacts and Locations

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): NCT01205269


Locations
Poland
Research Site
Białystok, Poland
Research Site
Bydgoszcz, Poland
Research Site
Proszowice, Poland
Research Site
Łódź, Poland
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Piotr Kuna, MD Professor Poland
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01205269     History of Changes
Other Study ID Numbers: D1883C00004
EudraCT number: 2010-020506-15
First Posted: September 20, 2010    Key Record Dates
Results First Posted: November 13, 2013
Last Update Posted: March 19, 2014
Last Verified: February 2014

Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease (COPD)
safety
inhalation
long-acting muscarinic receptor antagonist (LAMA)

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