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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study will assess the efficacy and safety of multiple dose levels of AZD7594 administered once daily (QD) by inhalation in a 12-week treatment period on asthma subjects. The activity will be assessed by comparing AZD7594 to placebo. The comparison between active comparator (FF) and placebo will be used for bench marking. The efficacy is assessed by the evaluation of change in trough forced expiratory volume in 1 second (FEV1). The aim is to develop AZD7594 as a once daily inhaled non-steroidal selective GR modulator (SGRM), which may ultimately lead to better disease control of both chronic obstructive pulmonary disease (COPD) and asthma through improved efficacy and compliance. The overall rationale for developing a once daily AZD7594 in a dry powder inhaler (DPI) is to provide a safe and effective future treatment option for both asthma and COPD subjects.
This is a randomised, placebo-controlled, double-blind multi center (8 countries: Europe, United States [US], South Africa, and Japan) study conducted on 714 subjects (102 subject per arm) with asthma symptomatic on low dose inhaled corticosteroids (ICS). The study consists of 3 periods:
The Run-in period consist of 3 visits: Screening visit (1), reversibility visit (2) and randomization visit (3). All subjects will sign an informed consent form (ICF) prior to participating in any study-specific procedures. Subjects found to be eligible at Visit 1 (Screening Visit) will discontinue all asthma medications and switch to low dose budesonide (200 μg twice a day [BID] in Europe and 180 μg BID in US) and rescue medication will be taken as needed. Subjects on long-acting beta agonist (LABA), fixed dose combination ICS/LABA treatment or a long-acting muscarinic antagonist (LAMA) will return for Visit 2 between 2 to 7 days after Visit 1 to have a sufficient wash-out time of their asthma medications. If reversibility criteria are met at Visit 2, subjects will proceed to Visit 3 (Randomization will occur within 21 to 28 days of Visit 1). At Visit 3, subjects who remain symptomatic while on low dose budesonide will be randomized in an overall ratio of 1:1:1:1:1:1:1 to one of 7 possible treatments and will receive inhalation powder via oral route:
The total duration of the study will be between 113 to 135 days for each individual subject and is planned to run approximately 12 months (it should not exceed 18 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD7594 Dose 1 | Experimental | The randomized subjects will receive AZD7594 55 μg/50 μg (nominal/delivered dose), oral inhalation via dry powder inhaler (DPI) once daily. |
|
| AZD7594 Dose 2 | Experimental | The randomized subjects will receive AZD7594 99 µg/90 µg, oral inhalation via DPI once daily. |
|
| AZD7594 Dose 3 | Experimental | The randomized subjects will receive treatment with AZD7594 198 µg/180 µg, oral inhalation via DPI once daily. |
|
| AZD7594 Dose 4 | Experimental | The randomized subjects will receive treatment with AZD7594 396 µg/360 µg, oral inhalation via DPI once daily. |
|
| AZD7594 Dose 5 | Experimental | The randomized subjects will receive treatment with AZD7594 792 µg/720 µg, oral inhalation via DPI once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7594 DPI 55μg/50μg. | Drug | A non-steroidal and selective modulator of the GR. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough FEV1 at Week 12 | Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analyses were based on a Mixed-effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose Inhaled corticosteroid (ICS). | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough FEV1 at Weeks 2, 4, 8 and Average Over the Treatment Period | Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analysis of covariance (ANCOVA) with treatment and region (ie, US, Japan, and RoW) as fixed effects, and baseline as covariate was used for the analysis of average over the Treatment Period. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. |
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Inclusion criteria
1. Provision of informed consent prior to any study-specific procedures 2. Men and women 18 to 85 years of age, inclusive, with body mass index (BMI)≤35 3. Subjects need to be non-smokers or ex-smokers (have quit e cigarettes or other inhaled tobacco products ≥6 months before Visit 1) with a total smoking history of less than 10 pack-years (not applicable for e cigarettes) 4. Documented clinical diagnosis of asthma for ≥6 months before Visit 1 5. Subjects on stable medium to high dose ICS (equivalent of budesonide >400 μg/day) or low to medium dose ICS/LABA for at least 4 weeks prior to screening (Visit 1) (Appendix A, GINA, 2018) 6. Subjects must demonstrate reversibility to inhaled bronchodilators at Visit 2 (a ≥12% and ≥200 mL improvement in FEV1 after administration of a 4 puffs of salbutamol/albuterol) 7. Pre-bronchodilator FEV1 at Visit 3 between 40% and 90% predicted at either -45 or -15 minutes pre-dose 8. At Visit 3, subjects need to be symptomatic on low dose ICS as evidenced by combined daily asthma mean symptom score of >1 over the previous 7 days or SABA use on ≥3 of the last 7 days during the Run-in Period 9. Demonstrate the ability to use the study inhalation device properly 10. Subject able to perform acceptable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society (ATS/ERS) acceptability criteria 11. Subject is willing and able to follow study procedures and restrictions. Women of child bearing potential (WOCBP) should be stable on their chosen method of highly effective birth control for a minimum of 3 months prior to Visit 1, and willing to use that for the entire duration of the study (from the time they sign the informed consent), and for 1 month after the last dose of IP 12. For optional inclusion in the Gx component of the study, subjects must provide separate informed consent for the genomic sampling and analysis Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kai Michael Beeh, Dr med | Insaf - Institut für Atemwegsforschung GmbH, D65187, Germany. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sheffield | Alabama | 35660 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| The CSP redacted. | View source |
| The SAP redacted. | View source |
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Subjects attended a Screening Visit within 28 days before receiving their first dose. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. One patient in the AZD7594 50 μg treatment arm did not receive any treatment and was randomised in error (protocol deviation).
The study was conducted in 92 sites in 8 countries; Bulgaria, Germany, Hungary, Poland, and Ukraine, United States (US), South Africa, and Japan. In this study, 806 patients (including 82 Japanese patients) were randomised. For sites in the US, no patients were randomised to the AZD7594 792 μg/720 μg once daily (QD) treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD7594 50 μg | Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily. |
| FG001 | AZD7594 90 μg | Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2019 | Sep 24, 2020 |
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All double-blind medication kits will have similar appearance regardless of the IP (AZD7594 or placebo) contained in a DPI device and will be labelled using a unique medication identification number (Kit ID) that is linked to a treatment arm. IVRS/IWRS will assign the study medication to be dispensed to each subjects at Visit 3.
Supplies of budesonide, FF and SABA (salbutamol/albuterol) will be open-label.
| Placebo |
| Placebo Comparator |
The randomized subjects will receive AZD7594 matching placebo oral inhalation via DPI once daily. |
|
| Fluticasone Furoate | Active Comparator | The randomized subjects will receive treatment with fluticasone furoate (FF) oral inhalation via DPI, 100 µg per nominal dose, once daily (open-label). |
|
| AZD7594 DPI 99 µg/90 µg |
| Drug |
A non-steroidal and selective modulator of the GR. |
|
| AZD7594 DPI 198 µg/180 µg | Drug | A non-steroidal and selective modulator of the GR. |
|
| AZD7594 DPI 396 µg/360 µg once daily. | Drug | A non-steroidal and selective modulator of the GR. |
|
| AZD7594 DPI 792 µg/720 µg | Drug | A non-steroidal and selective modulator of the GR. |
|
| Placebo for AZD7594 once daily. | Drug | Placebo for AZD7594 |
|
| FF 100 µg once daily (open-label) | Drug | Fluticasone furoate |
|
| At week 2, 4 and 8 |
| Change From Baseline in Fractional Exhaled Nitic Oxide (FENO) at Weeks 2, 4, 8, 12 and Average Over the Treatment Period | Baseline was defined as the last value obtained prior to the first dose of investigational product. Analyses were based on a MMRM with change from baseline on the log-scale as the response, treatment, visit, treatment by visit interaction and region as fixed effects, and log-transformed baseline value and baseline by visit interaction as covariates. | At week 2, 4, 8, and 12 |
| Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12 and Average Over the Treatment Period | Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analyses were based on a MMRM with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. | At week 12 |
| Change From Baseline in Asthma Control Questionnaire -5 (ACQ-5) at Week 12 and Average Over the Treatment Period | Baseline was defined as the ACQ-5 score at Visit 3. Analyses were based on a MMRM with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Patients are asked to recall how their asthma was during the previous week and to evaluate their symptoms. The questionnaire has 5 items each item is scored on a scale of 0 to 6, where higher scores represent more severe impairment/symptoms. ACQ is the sum of the scores from all 5 items. | At week 12 |
| Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period | Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Average Evening PEF Over the Treatment Period | Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Average Daily Use of Rescue Medication Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Percent Night-time Awakening Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Average Daily Asthma Symptom Score Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS (Full Analysis Set). Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. During the Run-in and Treatment Periods, subjects recorded the severity of their asthma symptoms during night-time and day-time each morning and evening, using the eDiary. Asthma symptom scores during night-time/day-time were assessed by the subject each morning/evening according to the following scoring system and recorded on the eDiary: 0: No asthma symptoms, 1: The subjects were aware of their asthma symptoms but they can easily tolerate the symptoms, 2: asthma was causing enough discomfort to cause problems with sleep, 3: Subjects were unable to sleep/do normal activities because of their asthma. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Percent Asthma Control Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Asthma-control days is defined as days with no symptoms, nonight-waking, no reliever use, and no exacerbation. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Percent Rescue-free Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. A rescue-free day (RFD) was defined as a day where the number of puffs of medication for the relief of asthma symptoms was reported as zero. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Week 0 (7 days prior to randomisation) to Week 12 |
| Change From Baseline in Percent Symptom-free Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Days without asthma symptoms, or symptom-free days, are defined as a day without asthma symptoms, short-acting β-agonist (SABA) use, systemic corticosteroid use, or need for urgent asthma care. | Week 0 (7 days prior to randomisation) to Week 12 |
| Observed Maximum Concentration at Steady State (Css,Max) of AZD7594 at Day 84 | Summary of PK parameter Css,mx, observed maximum concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Observed Minimum Concentration at the End of the Dosing Interval (Css,Min) of AZD7594 at Day 84 | Summary of PK parameter Css,min, observed minimum concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Time to Maximum Concentration at Steady State, Taken Directly From the Individual Concentration-time Curve (Tss, Max) of AZD7594 at Day 84 | Summary of PK parameter tss, max, Time to maximum concentration at steady state, taken directly from the individual concentration-time curve, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Time of Last Quantifiable Analyte Concentration (Tlast) of AZD7594 at Day 84 | Summary of PK parameter Tlast, Time of last quantifiable analyte concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUClast) of AZD7594 at Day 84 | Summary of PK parameter AUClast, Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Area Under the Plasma Concentration-curve Within a Dosing Interval (AUCτ) of AZD7594 at Day 84 | Summary of PK parameter AUCτ, Area under the plasma concentration-curve within a dosing interval, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Average Plasma Concentration During a Dosing Interval at Steady State (Css,Avg) of AZD7594 at Day 84 | Summary of PK parameter Css,avg, Average plasma concentration during a dosing interval at steady state, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Dose Normalised Css,Max (Css,Max/D) of AZD7594 at Day 84 | Summary of PK parameter Css,max/D Dose normalised Css,max, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Dose Normalised AUCτ (AUCτ/D) of AZD7594 at Day 84 | Summary of PK parameter AUCτ/D, Dose normalised AUCτ, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Percentage Fluctuation of AZD7594 at Day 84 | To describe the (steady state) PK of AZD7594 in a subset of asthmatics symptomatic on low dose ICS (subset of subjects at EU sites) (PK Analysis Set). The presented results are summary statistics of the PK parameter. No statistical analysis is done for this endpoint. Fluctuation index during a dosing interval estimated as 100*(Css,max - Css,min)/Css,avg (%), where Css,min is the minimum concentration at the end of the dosing interval. | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
| Change From Baseline in Area Under Plasma Cortisol Concentration-time Curve (AUEC0-24hrs Post Dose), of AZD7594 vs Placebo at Day 84 | Area under the plasma cortisol concentration-time curve from zero to 24 hours after dosing compared to Placebo, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | At Day -1 (-24 to -12 h prior to the dose on Day 0) and at Day 84 (0 to 12 hours post dose) |
| Number of Participants With Adverse Events | To evaluate the safety and tolerability of AZD7594 in relation to Placebo in asthmatics symptomatic on low dose ICS | From screening to follow-up period (7 to 10 days after visit 7) |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Research Site | Fullerton | California | 92835 | United States |
| Research Site | Gold River | California | 95670 | United States |
| Research Site | New Haven | Connecticut | 06520 | United States |
| Research Site | Celebration | Florida | 34747 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Port Orange | Florida | 32127 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | Farmington Hills | Michigan | 48336 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Gastonia | North Carolina | 28054 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Dublin | Ohio | 43016 | United States |
| Research Site | Medford | Oregon | 97504-9741 | United States |
| Research Site | Portland | Oregon | 97202 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Boerne | Texas | 78006 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Gabrovo | 5300 | Bulgaria |
| Research Site | Kozloduy | 3320 | Bulgaria |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Rousse | 7002 | Bulgaria |
| Research Site | Sofia | 1407 | Bulgaria |
| Research Site | Sofia | 1606 | Bulgaria |
| Research Site | Stara Zagora | 6000 | Bulgaria |
| Research Site | Vidin | 3700 | Bulgaria |
| Research Site | Berlin | 10119 | Germany |
| Research Site | Berlin | 10625 | Germany |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Berlin | 10969 | Germany |
| Research Site | Berlin | 14050 | Germany |
| Research Site | Dortmund | 44263 | Germany |
| Research Site | Großhansdorf | 22927 | Germany |
| Research Site | Hamburg | 20354 | Germany |
| Research Site | Hanover | D-30173 | Germany |
| Research Site | Lübeck | 23552 | Germany |
| Research Site | Marburg | 35037 | Germany |
| Research Site | Wiesbaden | 65187 | Germany |
| Research Site | Balassagyarmat | 2660 | Hungary |
| Research Site | Budapest | H-1036 | Hungary |
| Research Site | Gödöllő | 2100 | Hungary |
| Research Site | Komló | 7300 | Hungary |
| Research Site | Miskolc | 3529 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Pécs | 7635 | Hungary |
| Research Site | Százhalombatta | H-2400 | Hungary |
| Research Site | Szigetszentmiklós | 2310 | Hungary |
| Research Site | Szombathely | 9700 | Hungary |
| Research Site | Chūōku | 103-0028 | Japan |
| Research Site | Fukuoka | 811-1394 | Japan |
| Research Site | Fukuoka | 819-8555 | Japan |
| Research Site | Himeji | 672-8064 | Japan |
| Research Site | Kagoshima | 890-0073 | Japan |
| Research Site | Kishiwada-shi | 596-8501 | Japan |
| Research Site | Naka-gun | 319-1113 | Japan |
| Research Site | Osaka | 531-0073 | Japan |
| Research Site | Sakaide-shi | 762-8550 | Japan |
| Research Site | Shinjuku-ku | 169-0073 | Japan |
| Research Site | Tokyo | 103-0027 | Japan |
| Research Site | Yanagawa-shi | 832-0059 | Japan |
| Research Site | Yokohama | 232-0064 | Japan |
| Research Site | Bialystok | 15-044 | Poland |
| Research Site | Częstochowa | 42-200 | Poland |
| Research Site | Kielce | 25-751 | Poland |
| Research Site | Krakow | 30-033 | Poland |
| Research Site | Ksawerów | 95-054 | Poland |
| Research Site | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Research Site | Proszowice | 32-100 | Poland |
| Research Site | Skarżysko-Kamienna | 26-110 | Poland |
| Research Site | Skierniewice | 96-100 | Poland |
| Research Site | Sopot | 81-741 | Poland |
| Research Site | Tarnów | 33-100 | Poland |
| Research Site | Bellville | 7530 | South Africa |
| Research Site | Johannesburg | 1724 | South Africa |
| Research Site | Mowbray | 7700 | South Africa |
| Research Site | Port Elizabeth | 6001 | South Africa |
| Research Site | Cherkasy | 18009 | Ukraine |
| Research Site | Ivano-Frankivsk | 76018 | Ukraine |
| Research Site | Kharkiv Region | 61002 | Ukraine |
| Research Site | Kharkiv Region | 61039 | Ukraine |
| Research Site | Kharkiv Region | 61124 | Ukraine |
| Research Site | Kyiv | 02002 | Ukraine |
| Research Site | Kyiv | 02125 | Ukraine |
| Research Site | Kyiv | 04201 | Ukraine |
| Research Site | Kyiv | 3049 | Ukraine |
| Research Site | Lutsk | 43005 | Ukraine |
| Research Site | Odesa | 65025 | Ukraine |
| Research Site | Poltava | 36011 | Ukraine |
| Research Site | Sumy | 40031 | Ukraine |
| Research Site | Vinnytsia | 21018 | Ukraine |
| Research Site | Zaporizhzhia | 69035 | Ukraine |
| FG002 | AZD7594 180 μg | Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily. |
| FG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| FG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| FG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| FG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD7594 50 μg | Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily. |
| BG001 | AZD7594 90 μg | Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily. |
| BG002 | AZD7594 180 μg | Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily. |
| BG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| BG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| BG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| BG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Trough FEV1 at Week 12 | Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analyses were based on a Mixed-effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose Inhaled corticosteroid (ICS). | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | At week 12 |
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| Secondary | Change From Baseline in Trough FEV1 at Weeks 2, 4, 8 and Average Over the Treatment Period | Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analysis of covariance (ANCOVA) with treatment and region (ie, US, Japan, and RoW) as fixed effects, and baseline as covariate was used for the analysis of average over the Treatment Period. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. | Full analysis set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | At week 2, 4 and 8 |
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| Secondary | Change From Baseline in Fractional Exhaled Nitic Oxide (FENO) at Weeks 2, 4, 8, 12 and Average Over the Treatment Period | Baseline was defined as the last value obtained prior to the first dose of investigational product. Analyses were based on a MMRM with change from baseline on the log-scale as the response, treatment, visit, treatment by visit interaction and region as fixed effects, and log-transformed baseline value and baseline by visit interaction as covariates. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ppb | At week 2, 4, 8, and 12 |
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| Secondary | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12 and Average Over the Treatment Period | Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analyses were based on a MMRM with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | At week 12 |
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| Secondary | Change From Baseline in Asthma Control Questionnaire -5 (ACQ-5) at Week 12 and Average Over the Treatment Period | Baseline was defined as the ACQ-5 score at Visit 3. Analyses were based on a MMRM with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Patients are asked to recall how their asthma was during the previous week and to evaluate their symptoms. The questionnaire has 5 items each item is scored on a scale of 0 to 6, where higher scores represent more severe impairment/symptoms. ACQ is the sum of the scores from all 5 items. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 12 |
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| Secondary | Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period | Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Average Evening PEF Over the Treatment Period | Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. | Full Analysis set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Average Daily Use of Rescue Medication Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | number of puffs | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Percent Night-time Awakening Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percentage | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Average Daily Asthma Symptom Score Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS (Full Analysis Set). Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. During the Run-in and Treatment Periods, subjects recorded the severity of their asthma symptoms during night-time and day-time each morning and evening, using the eDiary. Asthma symptom scores during night-time/day-time were assessed by the subject each morning/evening according to the following scoring system and recorded on the eDiary: 0: No asthma symptoms, 1: The subjects were aware of their asthma symptoms but they can easily tolerate the symptoms, 2: asthma was causing enough discomfort to cause problems with sleep, 3: Subjects were unable to sleep/do normal activities because of their asthma. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Percent Asthma Control Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Asthma-control days is defined as days with no symptoms, nonight-waking, no reliever use, and no exacerbation. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percent | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Percent Rescue-free Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. A rescue-free day (RFD) was defined as a day where the number of puffs of medication for the relief of asthma symptoms was reported as zero. Baseline was defined as the average over the 7 days prior to randomisation. Analyses were based on an ANCOVA model with treatment and region as fixed effects, and baseline value as a covariate. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percent | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Change From Baseline in Percent Symptom-free Days Over the Treatment Period | To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose ICS. Days without asthma symptoms, or symptom-free days, are defined as a day without asthma symptoms, short-acting β-agonist (SABA) use, systemic corticosteroid use, or need for urgent asthma care. | Full Analysis Set: All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percent | Week 0 (7 days prior to randomisation) to Week 12 |
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| Secondary | Observed Maximum Concentration at Steady State (Css,Max) of AZD7594 at Day 84 | Summary of PK parameter Css,mx, observed maximum concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Observed Minimum Concentration at the End of the Dosing Interval (Css,Min) of AZD7594 at Day 84 | Summary of PK parameter Css,min, observed minimum concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Time to Maximum Concentration at Steady State, Taken Directly From the Individual Concentration-time Curve (Tss, Max) of AZD7594 at Day 84 | Summary of PK parameter tss, max, Time to maximum concentration at steady state, taken directly from the individual concentration-time curve, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Median | Full Range | hours | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Time of Last Quantifiable Analyte Concentration (Tlast) of AZD7594 at Day 84 | Summary of PK parameter Tlast, Time of last quantifiable analyte concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Median | Full Range | hours | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUClast) of AZD7594 at Day 84 | Summary of PK parameter AUClast, Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomized patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pmol/L | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Area Under the Plasma Concentration-curve Within a Dosing Interval (AUCτ) of AZD7594 at Day 84 | Summary of PK parameter AUCτ, Area under the plasma concentration-curve within a dosing interval, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pmol/L | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Average Plasma Concentration During a Dosing Interval at Steady State (Css,Avg) of AZD7594 at Day 84 | Summary of PK parameter Css,avg, Average plasma concentration during a dosing interval at steady state, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Dose Normalised Css,Max (Css,Max/D) of AZD7594 at Day 84 | Summary of PK parameter Css,max/D Dose normalised Css,max, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L/umol | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Dose Normalised AUCτ (AUCτ/D) of AZD7594 at Day 84 | Summary of PK parameter AUCτ/D, Dose normalised AUCτ, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pmol/μmol | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Percentage Fluctuation of AZD7594 at Day 84 | To describe the (steady state) PK of AZD7594 in a subset of asthmatics symptomatic on low dose ICS (subset of subjects at EU sites) (PK Analysis Set). The presented results are summary statistics of the PK parameter. No statistical analysis is done for this endpoint. Fluctuation index during a dosing interval estimated as 100*(Css,max - Css,min)/Css,avg (%), where Css,min is the minimum concentration at the end of the dosing interval. | All randomised patients participating in the PK subset, who took at least one dose of IP and for whom at least one of the primary PK parameters could be calculated, and who had no major protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | Day 84 (pre-dose and 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0 and 24 h post-dose) |
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| Secondary | Change From Baseline in Area Under Plasma Cortisol Concentration-time Curve (AUEC0-24hrs Post Dose), of AZD7594 vs Placebo at Day 84 | Area under the plasma cortisol concentration-time curve from zero to 24 hours after dosing compared to Placebo, of AZD7594 at day 84 in PK analysis set. The presented results are summary statistics of the PK parameter. | All randomised patients who took at least one dose of IP and for whom 24-hour cortisol sampling was performed and baseline and post baseline AUEC0-24 could be calculated. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng*hr/mL | At Day -1 (-24 to -12 h prior to the dose on Day 0) and at Day 84 (0 to 12 hours post dose) |
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| Secondary | Number of Participants With Adverse Events | To evaluate the safety and tolerability of AZD7594 in relation to Placebo in asthmatics symptomatic on low dose ICS | All participants randomised and receiving at least 1 dose of randomised study drug. | Posted | Count of Participants | Participants | From screening to follow-up period (7 to 10 days after visit 7) |
|
From Screening to follow-up period (7 to 10 days after visit 7), maximum up to 1 year.
An AE was the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition could be symptoms (e.g: nausea, chest pain), signs (e.g: tachycardia, enlarged liver) or abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). SAEs were recorded from the time of informed consent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD7594 50 μg | Oral inhalation of AZD5794 55 microgram/ 50 microgram (nominal dose/delivered dose) once daily. | 0 | 110 | 0 | 110 | 14 | 110 |
| EG001 | AZD7594 90 μg | Oral inhalation of AZD5794 99 microgram/ 90 microgram (nominal dose/delivered dose) once daily. | 0 | 112 | 3 | 112 | 15 | 112 |
| EG002 | AZD7594 180 μg | Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily. | 0 | 111 | 1 | 111 | 8 | 111 |
| EG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. | 1 | 113 | 3 | 113 | 14 | 113 |
| EG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. | 0 | 134 | 3 | 134 | 8 | 134 |
| EG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. | 0 | 113 | 0 | 113 | 24 | 113 |
| EG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. | 0 | 112 | 1 | 112 | 11 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Spinal compression fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca AB | 301-398-5799 | ClinicalTrialTransparency@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Sep 24, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Final Values) |
| -0.054 |
| 2-Sided |
| 95 |
| -0.143 |
| 0.035 |
| Superiority |
| Mixed Models Analysis | 0.389 | Mean Difference (Final Values) | 0.039 | 2-Sided | 95 | -0.050 | 0.128 | Superiority |
| Mixed Models Analysis | 0.094 | Mean Difference (Final Values) | 0.076 | 2-Sided | 95 | -0.013 | 0.165 | Superiority |
| Mixed Models Analysis | 0.060 | Mean Difference (Final Values) | 0.082 | 2-Sided | 95 | -0.003 | 0.167 | Superiority |
| Mixed Models Analysis | 0.014 | Mean Difference (Final Values) | 0.111 | 2-Sided | 95 | 0.023 | 0.199 | Superiority |
Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily.
| OG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
| OG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily.
| OG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
| OG002 | AZD7594 180 μg | Oral inhalation of AZD5794 198 microgram/ 180 microgram (nominal dose/delivered dose) once daily. |
| OG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
| OG003 |
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
| OG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily.
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
| OG003 | AZD7594 360 μg | Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
| AZD7594 360 μg |
Oral inhalation of AZD5794 396 microgram/ 360 microgram (nominal dose/delivered dose) once daily. |
| OG004 | AZD7594 720 μg | Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
| OG004 |
| AZD7594 720 μg |
Oral inhalation of AZD5794 792 microgram/ 720 microgram (nominal dose/delivered dose) once daily. |
| OG005 | Placebo to AZD7594 | Oral inhalation of placebo to AZD7594 once daily. |
| OG006 | Fluticasone Furoate | Oral inhalation of fluticasone furoate 100 microgram once daily. |
|
|
|
|
|
|
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