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
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014