This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma. The study is planned to be conducted at 4-10 study sites in the United States. The study intends to include 24 patients (12 to 17-year-old patients). For each patient, the duration of participation in the study will be approximately 5 to 7 weeks (37 to 52 days).
This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma. The study is planned to be conducted at 4-10 study sites in the United States. Eligible 12 to 17-year-old patients with asthma controlled on Global Initiative for Asthma (GINA) step 2 medication (ie, low dose inhaled corticosteroid \[ICS\] or leukotriene receptor antagonist \[LTRA\]), as evidenced by an asthma control questionnaire (ACQ-5) score ≤1.5, will be asked to stop their ongoing asthma maintenance treatment. After a washout period (14 to 21 days), all patients with confirmed reversibility will start study treatment, consisting of inhalations of AZD7594 (360 µg, delivered dose, via dry powder inhaler \[DPI\]) once daily for 15 to 16 days. The study intends to include 24 patients in order to have 18 evaluable patients, enrolled in equal proportion in the age group of 12 to 14 years (inclusive), and the age group of 15 to 17 years (inclusive), with at least 7 patients in each subgroup. For each patient, the duration of participation in the study will be approximately 5 to 7 weeks (37 to 52 days)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
During treatment period, AZD7594 (360 µg per day) will be administered as oral inhalation via dry powder inhaler or DPI (SD3FL inhaler).
Research Site
Rolling Hills Estates, California, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Bethesda, Maryland, United States
Maximum observed plasma concentration at steady state (Cmax,ss) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Minimum observed plasma concentration at steady state (Cmin,ss) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Observed trough plasma concentration at end of dosing interval (τ) (Ctrough) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Time of maximum observed plasma concentration at steady state (tmax,ss) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Area under the plasma concentration-time curve over a dosing interval (τ) at steady state (AUCτ) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Area under the plasma concentration curve from time zero to 12 hours post-dose (AUC0-12) under plasma concentration at Day 15 as part of PK evaluation
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Research Site
Kansas City, Missouri, United States
Research Site
Columbus, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Boerne, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Murray, Utah, United States
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Apparent total body clearance after extravascular administration at steady state (CLss/F) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Relative change from baseline in plasma cortisol area under the effect curve from time zero to 12 hours post-dose (AUEC0-12) on Day 15 as part of PD evaluation
To evaluate the PD of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: Pre-dose and 2, 4, 6, 8, 12 hours post-dose at Day 15
Change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 as part of PD evaluation
To evaluate the PD of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma.
Time frame: At screening, Day 1 (pre-dose and 5, 15, 60 minutes post dose), Day 15 (pre-dose) and at end of study
Change from baseline in asthma control questionnaire (ACQ-5) on Day 15 as part of PD evaluation
To evaluate the PD of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma. ACQ-5 is a 5 item questionnaire that scores symptoms on a 0-6 scale (where 0=none/no symptoms and 6=worst symptoms) . The form is completed by the patient during visits.
Time frame: At screening, Day 1 (pre-dose) and Day 15 (pre-dose)