Chronic obstructive pulmonary disease, COPD MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AZD8683 Turbuhaler
Product Code: AZD8683 Turbuhaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: -
CAS Number: 1194737-07-9
Current Sponsor code: AZD8683 bromide
Concentra
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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 be stable on a highly effective contraceptive method Clinical diagnosis of COPD for more than 1 year at Visit 1 FEV1 = 30 to =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the bronchodilatory effects of 4 different single doses of inhaled AZD8683 compared with placebo, with respect to peak and trough forced expiratory volume in the first second (FEV1), in patients with COPD.;Secondary Objective: To investigate dose-response within the tested dose-range for AZD8683 with respect to peak, trough, and average FEV1 To investigate the bronchodilatory effects of 4 different single doses of inhaled AZD8683 compared with an active comparator, Spiriva® (tiotropium bromide), with respect to peak, trough and average FEV1 To investigate the systemic effects with respect to heart rate (HR), QTcF, systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 4 different single doses of inhaled AZD8683 To investigate the safety and tolerability of single doses of inhaled AZD8683 To investigate AZD8683 plasma exposure after single doses of inhaled AZD8683 ;Primary end point(s): (1) Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments (2) Trough FEV1defined as the average FEV1 from the spirometry assessments;Timepoint(s) of evaluation of this end point: (1) During the first 24 hours following dose administration (2) During 22 to 26 hours following dose administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Average FEV1 from the spirometry assessments (2) Systemic effect by assessment of systolic blood pressure (SBP) (3) Systemic effect by assessment of diastolic blood pressure (DBP) (4) Systemic effect by assessment of heart rate (HR) (5) Systemic effect by assessment of QT interval corrected for heart rate using Fridericia's formula (QTcF) (6) Safety and tolerability of single doses of inhaled AZD8683 (7) Plasma concentrations of AZD8683 a single inhaled doses;Timepoint(s) of evaluation of this end point: (1) During the first 24 hours following dose administration (2) Change from pre-dose to maximum value during the first 24 hours following dose administration (3) Change from pre-dose to maximum value during the first 24 hours following dose administration (4) Change from pre-dose to maximum value during the first 24 hours following dose administration (5) Change from pre-dose to maximum value during the first 24 hours following dose administration (6) At screening, during 0-26 h post-dose and at follow-up (7) Pre-dose and during the first 24 hours following dose dministration | — |
Countries
Sweden
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed