| Primary | Part 1: Number of Participants With Adverse Events (AEs) | The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated. | The safety set included all patients who were randomised and received any investigational product (IP). | Posted | | Count of Participants | | Participants | | From Screening (Week -6) until Follow-up (Day 56) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 1: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| | Units | Counts |
|---|
| Participants | - OG00011
- OG00110
- OG00213
- OG003
|
| | Title | Denominators | Categories |
|---|
| Any AE | | |
| |
| Primary | Part 2: Change From Baseline in Pre-bronchodilator FEV1 | The efficacy of inhaled AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated. | The full analysis set included all patients who were randomised and received any IP. | Posted | | Least Squares Mean | Standard Error | Liters (L) | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 2: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Secondary | Part 1 and Part 2: Antidrug Antibodies (ADA) Titers | ADA-positive samples were tested to investigate the immunogenicity of AZD1402. | The immunogenicity set included all participants in the safety set with at least one post-treatment ADA result (positive or negative). Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. Participants in the Part 1: Placebo arm did not have any post-treatment ADA results and were excluded from analysis. | Posted | | Median | Inter-Quartile Range | Titer | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 1: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
|
| Secondary | Part 1 and Part 2: Maximum Observed Serum (Peak) Drug Concentration (Cmax) | The pharmacokinetic (PK) profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms Per Milliliter (ng/mL) | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours (h) | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Observed Lowest Drug Concentration Reached Before the Next Dose is Administered (Pre-dose) (Ctrough) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | |
|
| Secondary | Part 1 and Part 2: Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (L/h) | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Median | Full Range | Hours | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Time of Last Observed (Quantifiable) Concentration (Tlast) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Median | Full Range | Hours | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Accumulation Ratio for AUCτ (Rac AUC) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 1 and Part 2: Accumulation Ratio for Cmax (Rac Cmax) | The PK profile of AZD1402 was investigated. | The PK set included all patients in the safety set who had detectable PK data and with no major protocol deviations considered to impact on the analysis of PK data. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Day 1 until Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. |
|
| Secondary | Part 2: Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) at Week 4 and Average Over the Treatment Period | The efficacy of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA was further investigated. The ACQ was developed to measure asthma control. In the ACQ-6, participants were asked to recall how their asthma had been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated a worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Mean | Standard Deviation | Score on scale | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. |
|
| Secondary | Part 2: Participants With a Decrease in ACQ 6 Score of ≥ 0.5 From Baseline to Week 4 | The efficacy of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA was further investigated. The ACQ was developed to measure asthma control. In the ACQ-6, participants were asked to recall how their asthma had been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated a worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Count of Participants | | Participants | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. |
|
| Secondary | Part 2: Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period | The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Peak expiratory flow was measured by the participants at home using a peak flow meter. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Mean | Standard Deviation | Liters/minute (L/m) | | Baseline, 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 2: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Secondary | Part 2: Change From Baseline in Average Evening PEF Over the Treatment Period | The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Peak expiratory flow was measured by the participants at home using a peak flow meter. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Mean | Standard Deviation | Liters/minute (L/m) | | Baseline, 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 2: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Secondary | Part 2: Change From Baseline in Daily Average Asthma Symptom Score (AM/PM) Over the Treatment Period | The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Severity scores for asthma symptoms were recorded twice daily in the morning and evening and documented in an e-Diary. Asthma symptom scores during night-time and day-time were assessed by the participant each morning and evening according to the following scoring system: 0: You have no asthma symptoms. 1: You are aware of your asthma symptoms but you can easily tolerate the symptoms. 2: Your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep). 3: You are unable to do your normal activities (or to sleep) because of your asthma. Higher scores indicated worse outcome. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Mean | Standard Deviation | Score on scale | | Baseline, 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | |
|
| Secondary | Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period | The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Least Squares Mean | Standard Error | Liters (L) | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 2: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Secondary | Part 2: Change From Baseline in FeNO (In-clinic) at Week 4 and Average Over the Treatment Period | The effect of AZD1402 compared to placebo on airway inflammation in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO was performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation were followed such that plateau definition could be evaluated over a minimum of 3 seconds. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Parts per billion (ppb) | | Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 2: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
|
| Secondary | Part 2: Number of Participants With Adverse Events (AEs) | The safety and tolerability of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was evaluated. | The safety set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Count of Participants | | Participants | | From Screening (Week -6) until Follow-up (Day 56) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 2: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 2: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Primary | Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) | The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated. | The safety set included all patients who were randomised and received any IP. | Posted | | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | | Baseline, Day 12, Day 16, and Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 1: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Primary | Part 1: Change From Baseline in FEV1 In-clinic Spirometry | The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated. | The safety set included all patients who were randomised and received any IP. | Posted | | Mean | Standard Deviation | Liters (L) | | Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 1: Placebo | Randomised participants received oral inhalation of matching placebo via DPI. |
| |
| Primary | Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic) | The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated. | The full analysis set included all patients who were randomised and received any IP. Here, 'number of participants analyzed' specifies participants evaluated for this outcome measure at specific timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Part per billion (ppb) | | Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: AZD1402 Dose 1 | Randomised participants received oral inhalation of AZD1402 Dose 1 via DPI. | | OG001 | Part 1: AZD1402 Dose 2 | Randomised participants received oral inhalation of AZD1402 Dose 2 via DPI. | | OG002 | Part 1: AZD1402 Dose 3 | Randomised participants received oral inhalation of AZD1402 Dose 3 via DPI. | | OG003 | Part 1: Placebo | |
|