A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, … (NCT02479412) | Clinical Trial Compass
CompletedPhase 2
A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled, multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body mass index of 18 to 35 kg/m2
* 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 \< 10 pack years
* Documented clinical diagnosis of asthma for ≥ 6 months before the Visit 1
* Patients on low-dose inhaled corticosteroids (ICS) (equivalent of budesonide ≤ 400 μg per day) or low-dose ICS/long-acting β-2 agonist (LABA), or not on any inhaled steroids, or patients on montelukast
* Patients should be controlled on low dose budesonide during the first 14 ±2 days of Run-in Part 1, i.e., they need to have ACQ-5 of ≤ 1.5 at Visit 2.
* Prebronchodilator FEV1 at Visit 3 should be between 40% and 90% of predicted (mean of 2 predose measurements taken 30 minutes apart).
* All patients need to have FeNO concentrations of ≥ 25 parts per billion at Visit 3
* Demonstrate the ability to use the study inhalation device properly
* Women must be of nonchildbearing potential defined as meeting 1 of the following criteria:
* Permanently or surgically sterilized, including hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy
* Postmenopausal; aged ≤ 50 years and have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range
* Postmenopausal; aged \> 50 years and have been amenorrheic for 12 months or more,…
What they're measuring
1
Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15
Timeframe: On Day 1 (pre-dose) and on Day 15 in each period