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

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Potassium

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Peak Forced Expiratory Volume in 1 second (FEV1), defined as the maximum FEV1 measurement during the first 24 hours after dose administration [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
Trough FEV1, defined as the average FEV1 measurements 22 to 26 hour from dose administration [ Time Frame: 22 to 26 hours following dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average FEV1 (0-24h) [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
Systolic blood pressure (SBP) - maximum increase from pre-dose value [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
Diastolic blood pressure (DBP) - maximum decrease from pre-dose value [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
Heart rate (HR) - maximum increase from pre-dose value [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
QT interval corrected for heart rate using Fridericia's formula (QTcF) - maximum increase from pre-dose value [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
Plasma concentrations of AZD8683 a single inhaled doses [ Time Frame: The first 24 hours following dose administration ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: At enrolment until follow-up ] [ Designated as safety issue: No ]
Plasma/Serum (P/S)- Albumin [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Alanine aminotransferase (ALT) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Aspartate aminotransferase (AST) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Alkaline phosphatase (ALP) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Bilirubin (total) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Calcium (total) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Creatinine [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Glucose [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Potassium [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Sodium [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-C-reactive protein (CRP) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
S-Urea [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
P/S-Thyroid stimulating hormone (TSH) [ Time Frame: At enrolment and follow-up ] [ Designated as safety issue: No ]
P/S-Thyroxine free (T4) [ Time Frame: At enrolment and follow-up ] [ Designated as safety issue: No ]
Blood (B)-Haemoglobin [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Leucocyte [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Neutrophils [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Eosinophils [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Basophils [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Lymphocytes [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Monocytes [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Platelet count [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
B-Haematocrit/erythrocyte volume fraction (EVF) [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
Urine (U)-Glucose STRIP [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
U-Haemoglobin STRIP [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
U-Protein STRIP [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
U-pregnancy test [ Time Frame: At enrolment, before dosing and at follow-up ] [ Designated as safety issue: No ]
RR [ Time Frame: At enrolment, during 0-24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
PR [ Time Frame: At enrolment, during 0-24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
QRS [ Time Frame: At enrolment, during 0-24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
QT intervals [ Time Frame: At enrolment, during 0-24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: At enrolment, pre-dose and 24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
Pulse [ Time Frame: At enrolment, during 0-24 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]
FVC [ Time Frame: At enrolment, during 0-26 hours following dose administration and at follow-up ] [ Designated as safety issue: No ]

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

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
Last Updated:	December 20, 2012
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013