Study identifier:D3741C00012
ClinicalTrials.gov identifier:NCT03976869
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-Label, Multi-Centre, Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of 2-Week Treatment with Inhaled AZD7594 in Adolescents (12 to 17 years) with Asthma
asthma
Phase 1
No
AZD7594
All
36
Interventional
12 Years - 17 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2021 by AstraZeneca
AstraZeneca
PAREXEL
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)
Location
Location
Rolling Hills Estates, CA, United States, 90274
Location
Miami Lakes, FL, United States, 33015
Location
Oklahoma City, OK, United States, 73106
Location
Kansas City, MO, United States, 64114
Location
Murray, UT, United States, 84107
Location
Columbus, OH, United States, 43207
Location
Dallas, TX, United States, 75225
Location
Bethesda, Maryland, United States, 20814
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 The study will include adolescent patients of 12 to 17 years of age, with subgroups of 12-14 years age and 15-17 years age. | Drug: AZD7594 During treatment period, AZD7594 (360 µg per day) will be administered as oral inhalation via dry powder inhaler or DPI (SD3FL inhaler). |
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