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AZD8871 100 µg

Phase 2

Chronic Obstructive Pulmonary Disease COPD | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 18, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

AZD8871 100 µg · 1 trial · 1 indication

Phase 2 1
NCT02971293Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871Chronic Obstructive Pulmonary Disease COPD
COMPLETED42 Analytics
PHASE2COMPLETED
Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871
Chronic Obstructive Pulmonary Disease COPDUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
On Day 15

The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in trough FEV1 on Day 15

Secondary Endpoints

Observed Maximum Plasma (Cmax) of AZD8871 and Its Metabolites (Single Dose)
Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.
Observed Maximum Plasma (Cmax) of AZD8871 and Its Metabolites (Multiple Doses, Day 14)
Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.
Time to Reach Maximum Plasma Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose)
Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD8871 100 µgEXPERIMENTALThe subjects will receive AZD8871 100 µg once daily, by dry powder inhaler (DPI) device. The treatment will be administered via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
PlaceboPLACEBO_COMPARATORThe placebo will be administered via single dose DPI that is an adaptation of the commercially available Genuair® with a smaller internal volume to enable delivery of single doses. To maintain blinding, each patient will receive one inhaled dose from placebo DPI provided to him/her on each day of the treatment period.
AZD8871 600 µgEXPERIMENTALThe subjects will receive AZD8871 600 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.

Interventions

NameTypeDescription
AZD8871 100 µgDRUGThe subjects will receive one dose of AZD8871 100 µg single dose DPI.
AZD8871 600 µgDRUGThe subjects will receive AZD8871, 600 µg single dose DPI.
PlaceboDRUGThe subject will receive Placebo single dose DPI.
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patient who provided of informed consent prior to any study-specific procedures 2. Male or female 40 to 80 years of age (both inclusive) at Screening (Visit 1). A female is eligible to enter and participate in the study if she is of non-childbearing potential. Note: A fem...

Countries:GermanyUnited Kingdom
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Frequently asked questions about AZD8871 100 µg

What is AZD8871 100 µg used for?

AZD8871 100 µg is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered via inhalation. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes AZD8871 100 µg?

AZD8871 100 µg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy, pharmacokinetics, safety, and tolerability in patients with COPD.

What phase is AZD8871 100 µg in?

AZD8871 100 µg is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. A Phase 2 trial has been completed to assess its effects in patients with Chronic Obstructive Pulmonary Disease (COPD).

What clinical trials is AZD8871 100 µg in?

AZD8871 100 µg has been studied in one completed Phase 2 clinical trial with the identifier NCT02971293. This randomized, double-blind, placebo-controlled study enrolled 42 participants with Chronic Obstructive Pulmonary Disease (COPD) and was conducted in Germany and the United Kingdom.

Is AZD8871 100 µg the same as AZD8871?

AZD8871 100 µg is a specific dosage strength of the drug AZD8871. The 100 µg designation refers to the amount of the active ingredient in each inhaled dose. The drug is being developed by AstraZeneca for the treatment of Chronic Obstructive Pulmonary Disease (COPD).