Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT06795906
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AZD8630, Administered Once Daily Via Inhalation, for 2 Weeks, in Adults With Asthma on Medium-to-high Dose Inhaled Corticosteroids and Long-acting Beta-agonists
Status:
COMPLETED
Status Verified Date:
2025-09
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 randomised, placebo-controlled, double-blinded, sponsor-unblinded study to assess the safety, pharmacokinetic (PK), and pharmacodynamic (PD) effect of AZD8630 in adult participants with asthma on medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).
Detailed Description:
The purpose of this study is to assess the safety, PK, and PD of AZD8630 compared to placebo in participants with asthma and elevated fractional exhaled nitric oxide (FeNO) on a combination of medium-to-high dose ICS and LABA medications.
The study will comprise of:
* A Screening/Enrollment Period of up to 14 to 28 days before dosing.
* A Treatment Period/End of Treatment Visit. On Day 1, participants will be randomised to AZD8630 or corresponding placebo. Study intervention will be self-administered once daily up to Day 14. Participants will return to the study site for clinical and safety assessments on Day 7 and clinical and safety assessments and PK sampling on Day 14.
* A Follow-up Visit 1 week after last dose.
The study will comprise of:
* A Screening/Enrollment Period of up to 14 to 28 days before dosing.
* A Treatment Period/End of Treatment Visit. On Day 1, participants will be randomised to AZD8630 or corresponding placebo. Study intervention will be self-administered once daily up to Day 14. Participants will return to the study site for clinical and safety assessments on Day 7 and clinical and safety assessments and PK sampling on Day 14.
* A Follow-up Visit 1 week after last dose.
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?: