Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT06795906
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.
Study:
NCT06795906
Study Brief:
Protocol Section:
NCT06795906