Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-29 @ 7:53 AM
Study NCT ID:
NCT02971293
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2016-10-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase IIa, Randomised, Multi-Centre, Double-Blind, Placebo-Controlled, 3 Periods, Crossover Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Inhaled AZD8871 Administered Once Daily for 2 Weeks in Patients With Moderate to Severe COPD.
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This is a proof-of-concept, randomised, double-blind, placebo-controlled, 3-way, complete crossover William's design, multiple dose study to investigate the efficacy, PK, safety, and tolerability of 2 dose levels of AZD8871 and placebo, administered using a dry powder inhaler (DPI) device once daily, for 2 weeks, in patients with moderate to severe COPD. AZD8871 is a new chemical entity with the combined properties of a LAMA and a LABA in a single molecule. AZD8871 is being developed as an inhaled long-acting bronchodilator for the maintenance treatment of COPD.
The objective of the study is to assess the efficacy, safety and PK of AZD8871 after a 14-day treatment period at 2 different doses in patients with moderate to severe COPD. The target population includes male and female (non-childbearing potential) adult patients with clinical diagnosis of moderate to severe COPD. The crossover design has been chosen to avoid inter-patient variability and optimize sample size. By randomly assigning treatment sequence, differences in baseline characteristics of the treatment groups will be minimised. The inclusion of a placebo arm is considered the most reliable method to minimise patient and Investigator bias. The proposed dose levels of AZD8871 in this study are 100 and 600 µg of AZD8871 given by inhalation once daily for 14 days through a single dose DPI. Doses have been selected based on the safety, tolerability, PK and pharmacodynamics (PD) information generated in previous clinical trials with AZD8871. The wash-out period proposed for this current study is a minimum of 28 days and up to 35 days in order to avoid any carry over effect between periods. The broad dose range selected (6 fold range from 100 to 600 µg) has been chosen to span the likely therapeutic dose and facilitate the dose selection for future studies. Considering the expected efficacy in patients with COPD and the available data to date, it is anticipated the benefits will outweigh the risks and support the continued investigation of AZD8871 in clinical studies.
The objective of the study is to assess the efficacy, safety and PK of AZD8871 after a 14-day treatment period at 2 different doses in patients with moderate to severe COPD. The target population includes male and female (non-childbearing potential) adult patients with clinical diagnosis of moderate to severe COPD. The crossover design has been chosen to avoid inter-patient variability and optimize sample size. By randomly assigning treatment sequence, differences in baseline characteristics of the treatment groups will be minimised. The inclusion of a placebo arm is considered the most reliable method to minimise patient and Investigator bias. The proposed dose levels of AZD8871 in this study are 100 and 600 µg of AZD8871 given by inhalation once daily for 14 days through a single dose DPI. Doses have been selected based on the safety, tolerability, PK and pharmacodynamics (PD) information generated in previous clinical trials with AZD8871. The wash-out period proposed for this current study is a minimum of 28 days and up to 35 days in order to avoid any carry over effect between periods. The broad dose range selected (6 fold range from 100 to 600 µg) has been chosen to span the likely therapeutic dose and facilitate the dose selection for future studies. Considering the expected efficacy in patients with COPD and the available data to date, it is anticipated the benefits will outweigh the risks and support the continued investigation of AZD8871 in clinical studies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: