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

NCT01708057 | Terminated Phase 2 Results

• 2 other identifiers: D1883C00007EudraCT number: 2012-002900-42
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

COPD; Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Peak FEV1 (0-24h)

  The maximum value over 24 hours post-dose, as change from baseline

  The first 24 hours following dose administration

• Change From Baseline in Trough FEV1 (22-26h)

  The average over 22 to 26 hours, as change from baseline

  22 to 26 hours following dose administration

Secondary Outcomes (6)

• Average FEV1 as a Change From Baseline

  The first 24 hours following dose administration

• Maximum Increase in Systolic Blood Pressure [SBP]

  baseline, 24hr post dose

• Maximum Increase in Diastolic Blood Pressure [DBP]

  The first 24 hours following dose administration

• Maximum Increase Heart Rate [HR]

  baseline, 24hr post dose

• Maximum Increase in QTcF

  baseline, 24hr post dose

Study Arms (6)

1

EXPERIMENTAL

Single dose of AZD8683 50 µg

Drug: AZD8683

2

EXPERIMENTAL

Single dose of AZD8683 150 µg

Drug: AZD8683

3

EXPERIMENTAL

Single dose of AZD8683 300 µg

Drug: AZD8683

4

EXPERIMENTAL

Single dose of AZD8683 900 µg

Drug: AZD8683

5

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

6

ACTIVE COMPARATOR

Single dose of tiotropium 18 µg

Drug: Tiotropium

Interventions

AZD8683 DRUG

AZD8683 administered via inhalation

1; 2; 3; 4

Placebo DRUG

Placebo administered via inhalation

5

Tiotropium DRUG

Tiotropium administered via inhalation

6

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Proszowice, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Lund, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Carin Jorup
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Carin Jorup, MD

  AstraZeneca R&DMolndal, Sweden

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 15, 2014
• Results First Posted: September 30, 2013

Record last verified: 2013-12

Locations

SE (2); PL (4)