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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01205269
First received: September 15, 2010
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Maximum FEV1 value

  • Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose [ Time Frame: 22 h, 24 h, 26 h ] [ Designated as safety issue: No ]
    Trough FEV1 value


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Average FEV1 value

  • 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 ] [ Designated as safety issue: No ]
    Maximum FVC value

  • Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average systolic blood pressure value

  • Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average diastolic blood pressure value

  • Pulse, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average pulse value

  • Heart Rate, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average heart rate value

  • QTcF, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula

  • 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 ] [ Designated as safety issue: No ]
    Maximum plasma concentration of AZD8683

  • 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 ] [ Designated as safety issue: No ]
    Area under the AZD8683 plasma concentration curve from 0 to 24 hours


Enrollment: 28
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  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
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01205269     History of Changes
Other Study ID Numbers: D1883C00004, EudraCT number: 2010-020506-15
Study First Received: September 15, 2010
Results First Received: September 10, 2013
Last Updated: February 24, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

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

ClinicalTrials.gov processed this record on August 19, 2014