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).
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 uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks. This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
534
Time to first CompEx Asthma event
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
Time frame: 12 weeks
Pre-BD FEV1
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second.
Time frame: 12 weeks
ACQ-6:
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
Time frame: 12 weeks
AQLQ12+
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
Time frame: 12 weeks
SGRQ
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.
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Research Site
Mesa, Arizona, United States
Research Site
Huntington Beach, California, United States
Research Site
La Mesa, California, United States
Research Site
Laguna Niguel, California, United States
Research Site
Lancaster, California, United States
Research Site
Long Beach, California, United States
Research Site
San Jose, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
DeBary, Florida, United States
Research Site
Jacksonville, Florida, United States
...and 186 more locations
Time frame: 12 weeks
FeNO
Change from baseline to: FeNO: Weeks 1, 2, 4, 8, and 12
Time frame: 12 weeks