A multiple dosing (14 days) crossover, 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

Phase 1

• Conditions: Patients with mild to moderate asthma; MedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005306-37-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-25
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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 <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 ß-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-5of = 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified