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Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871

NCT02971293 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-06-18

Study results available
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Summary

This is a study to evaluate the effects of AZD8871 in patients with COPD. Adult male or female patients with moderate to severe COPD, who agree to be in this study, will receive 3 treatments, i.e. 2 different doses of AZD8871 and placebo (dummy medication containing no drug) at once a day for 2 weeks, in a random order. To make the comparison between AZD8871 and placebo as fair as possible, this study is "double blinded." This means that neither patient nor the study doctor will know in which order the 3 treatments will be given. This study will include patients who are between 40 and 80 years of age. In total there will be 42 patients participating in this study at two study centers in the United Kingdom and Germany. The study will have a total of 12 visits for each patient spanning for a period of 4 to 6 months. The study is anticipated to run for approximately 8 months and should not exceed 10 months.

Conditions

  • Chronic Obstructive Pulmonary Disease COPD

Interventions

DRUG

AZD8871 100 µg

The subjects will receive one dose of AZD8871 100 µg single dose DPI.

DRUG

AZD8871 600 µg

The subjects will receive AZD8871, 600 µg single dose DPI.

DRUG

Placebo

The subject will receive Placebo single dose DPI.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Dave Singh, Prof · Medicines Evaluation Unit, Manchester, United Kingdom

  • Rainard Fuhr, Dr · PAREXEL International GmbH EPCU Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2017-08-18
Completion
2017-08-18

Countries

  • Germany
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02971293 on ClinicalTrials.gov