A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations
- Registration Number
- NCT06529419
- Lead Sponsor
- AstraZeneca
- Brief Summary
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) and who have had ≥ 1 documented severe asthma exacerbation in the 12 months prior to enrolment.
- Detailed Description
This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with asthma, who have had at least one severe exacerbation within the last 12 months, and whose asthma remains uncontrolled on medium to high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA). AZD8630 will be delivered via the inhaler which is designed to be a self-administered device for use by patients. The treatment period is 12 weeks, with an optional safety extension period of up to 52 weeks of total dosing. The study will evaluate the incidence of CompEx Asthma and other efficacy parameters, such as lung function and quality of life, and will provide adequate safety information in order to characterise the benefit-risk profile of AZD8630 treatment in patients with asthma.
This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 516
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD8630 dose C Inhaler Inhaled AZD8630 administered at a dose C AZD8630 dose B Inhaler Inhaled AZD8630 administered at a dose B Placebo Placebo Inhaled placebo AZD8630 dose B AZD8630 Inhaled AZD8630 administered at a dose B Placebo Inhaler Inhaled placebo AZD8630 dose A Inhaler Inhaled AZD8630 administered at a dose A AZD8630 dose A AZD8630 Inhaled AZD8630 administered at a dose A AZD8630 dose C AZD8630 Inhaled AZD8630 administered at a dose C
- Primary Outcome Measures
Name Time Method Time to first CompEx Asthma event 12 weeks The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables:
* PEF
* Asthma symptom score (0 to 3)
* Use of rescue medication
- Secondary Outcome Measures
Name Time Method Pre-BD FEV1 12 weeks Change from baseline in pre-bronchodilator forced expiratory volume in 1 second.
ACQ-6: 12 weeks Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6). The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease
AQLQ12+ 12 weeks Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains
SGRQ 12 weeks Change from baseline in the St. George's Respiratory Questionnaire. The SGRQ includes 50 questions grouped into two parts: Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
FeNO 12 weeks Change from baseline to: FeNO: Weeks 1, 2, 4, 8, and 12
Trial Locations
- Locations (1)
Research Site
🇬🇧Portsmouth, United Kingdom