Patients with mild to moderate asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AZD7594 inhalation powder hard capsule 29 - 450 µg
Product Code: AZD7594 inhalation powder hard capsule 29 - 450 µg
Pharmaceutical Form: Inhalation powder, hard capsule
Current Sponsor c
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women 18 to 75 years of age, inclusive • Patients need to be non-smokers or ex-smokers (quit = 6 months before the Visit 1) with total smoking history of =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Known or suspected hypersensitivity to the IMPs or excipients, including lactose • Systemic steroid use in the 6 weeks before Visit 1 • Any active disease other than asthma • Patients on medium to high-dose ICS (equivalent of budesonide > 400 µg per day) or on inhaled anticholinergic combination within the 6 weeks prior to Visit 1 • Compliance with the eDiary of at least 80% of the days is expected in both Run-in and Treatment Periods. Patients with < 80% eDiary compliance during Run-in Periods would not be randomized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the efficacy of AZD7594 as measured by change in trough forced expiratory volume in 1 second (FEV1) from baseline, as compared to placebo.;Secondary Objective: The secondary objectives are: To investigate the effect of AZD7594 on patient-reported outcomes of Asthma Control Questionnaire (ACQ-5), daily symptoms, nighttime awakenings, use of daily rescue medication and morning peak expiratory flow (mPEF) and evening peak expiratory flow (ePEF) • To investigate the effect of AZD7594 on airway inflammation and hyper-reactivity, as measured by fractional exhaled nitric oxide (FeNO) • To investigate the pharmacokinetic (PK) profile of AZD7594 in patients with mild to moderate asthma • To investigate cortisol suppression from AZD7594, as measured by 24-hour plasma cortisol level;Primary end point(s): Efficacy: Change from baseline in morning trough FEV1 on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of IMP on Day 14 ;Timepoint(s) of evaluation of this end point: Efficacy: In each period: before the first dose and in the morning of Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • Change from baseline in FeNO on Day 8 • Change from baseline in FeNO on Day 15 • Change from baseline in morning trough FEV1 on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after the dose of IMP on Day 7) • Change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after the dose of IMP on Day 14) • Change from baseline in morning trough FVC on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after the dose of IMP on Day 7) • Change from baseline in mPEF before administration over the Treatment Period • Change from baseline in ePEF over the Treatment Period • Change from baseline in average daily use of rescue salbutamol over the Treatment Period • Change from baseline in ACQ-5 on Day 15 • Change from baseline in ACQ-5 on Day 8 • Change from baseline in nighttime awakenings over the Treatment Period • Change from baseline in daily symptom score over the Treatment Period • Change from baseline in asthma control days over the Treatment Period Pharmacokinetics (PK, intense PK subgroup): • Observed maximum plasma concentration (Cmax, Day 1 only) • Area under the plasma concentration-time curve from time zero to 4 hours after administration (AUC[0-4], Day 1 only) • Observed maximum plasma concentration at steady state (Cmax,ss, Day 14 only) • Area under the plasma concentration-time curve from time zero to 24 hours after administration (AUC[0-24], Day 14 only) • Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-last], Days 1 and 14) • Time to reach maximum plasma concentration (tmax, Day 1 only) • Time to reach maximum plasma concentration at steady state (tmax,ss, Day 14 only) • Average plasma concentration during a dosing interval at steady state (Cavg,ss, Day 14 only) • Dose-normalized Cmax (Cmax/D) • Dose-normaliz | — |
Countries
Bulgaria, Germany
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed