A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01708057
First received: October 1, 2012
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
Drug: AZD8683
Drug: Placebo
Drug: Tiotropium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses 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:
  • Change From Baseline in Peak FEV1 (0-24h) [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
    The maximum value over 24 hours post-dose, as change from baseline

  • Change From Baseline in Trough FEV1 (22-26h) [ Time Frame: 22 to 26 hours following dose administration ] [ Designated as safety issue: No ]
    The average over 22 to 26 hours, as change from baseline


Secondary Outcome Measures:
  • Average FEV1 as a Change From Baseline [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
    Average FEV1 (0-24h): The average over 0 to 24 hours

  • Maximum Increase in Systolic Blood Pressure [SBP] [ Time Frame: baseline, 24hr post dose ] [ Designated as safety issue: No ]
    Maximum (post-dose values - baseline value) for each treatment visit.

  • Maximum Increase in Diastolic Blood Pressure [DBP] [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
    Maximum (post-dose values - baseline value) for each treatment visit.

  • Maximum Increase Heart Rate [HR] [ Time Frame: baseline, 24hr post dose ] [ Designated as safety issue: No ]
    Maximum (post-dose values - baseline value) for each treatment visit.

  • Maximum Increase in QTcF [ Time Frame: baseline, 24hr post dose ] [ Designated as safety issue: No ]
    maximum (post-dose values - baseline value) for each treatment visit.

  • PK Parameters (AZD8683) [ Time Frame: Pre-dose, 24hr post-dose ] [ Designated as safety issue: No ]
    Cmax, tmax, AUC


Enrollment: 3
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single dose of AZD8683 50 µg
Drug: AZD8683
AZD8683 administered via inhalation
Experimental: 2
Single dose of AZD8683 150 µg
Drug: AZD8683
AZD8683 administered via inhalation
Experimental: 3
Single dose of AZD8683 300 µg
Drug: AZD8683
AZD8683 administered via inhalation
Experimental: 4
Single dose of AZD8683 900 µg
Drug: AZD8683
AZD8683 administered via inhalation
Placebo Comparator: 5
Single dose of placebo
Drug: Placebo
Placebo administered via inhalation
Active Comparator: 6
Single dose of tiotropium 18 µg
Drug: Tiotropium
Tiotropium administered via inhalation

Detailed Description:

A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses 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:

  • Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
  • Clinical diagnosis of COPD for more than 1 year at Visit 1
  • FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC < 70%
  • Reversible airway obstruction

Exclusion Criteria:

  • Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
  • An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
  • Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
  • Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
  • Long-term oxygen therapy, as judged by the Investigator
  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: NCT01708057

Locations
Poland
Bialystok, Poland
Lodz, Poland
Proszowice, Poland
Wroclaw, Poland
Sweden
Goteborg, Sweden
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carin Jorup, MD AstraZeneca R&DMolndal, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01708057     History of Changes
Other Study ID Numbers: D1883C00007, EudraCT number: 2012-002900-42
Study First Received: October 1, 2012
Results First Received: July 30, 2013
Last Updated: December 13, 2013
Health Authority: Sweden: Medical Products Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by AstraZeneca:
COPD
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014