A RANDOMIZED, DOUBLE BLIND, MULTIPLE DOSING (14 DAYS), PLACEBO-CONTROLLED, INCOMPLETE BLOCK 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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
54
2 countries
10
Study Start
June 25, 2015
Actual (reported)Primary Completion
February 8, 2016
Actual (reported)Study Completion
February 8, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 8, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2015
Actual (reported)June 24, 2015
Actual (reported)June 25, 2015
Actual (reported)February 8, 2016
Actual (reported)February 8, 2016
Actual (reported)June 23, 2017
Actual (reported)Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15
Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product \[IMP\] on Day 14) with placebo
On Day 1 (pre-dose) and on Day 15 in each period
Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8
On Day 1 (pre-dose) and on Day 8 in each period
Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15
On Day 1 (pre-dose) and on Day 15 in each period
Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8
On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period
Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15
On Day 1 (pre-dose) and on Day 15 (pre-dose) in each period
Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8
On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period
Placebo once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3
Placebo once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Research Site
Sofia, 1612, Bulgaria
Research Site
Berlin, 10717, Germany
Research Site
Berlin, 10969, Germany
Research Site
Berlin, 14050, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Großhansdorf, 22927, Germany
Research Site
Hamburg, 20354, Germany
Brown MN, Fuhr R, Beier J, Su HL, Chen Y, Forsman H, Hamren UW, Jackson H, Aggarwal A. Efficacy and safety of AZD7594, an inhaled non-steroidal selective glucocorticoid receptor modulator, in patients with asthma: a phase 2a randomized, double blind, placebo-controlled crossover trial. Respir Res. 2019 Feb 18;20(1):37. doi: 10.1186/s12931-019-1000-7.
Rainard Fuhr, Dr. med.
PAREXEL International GmbH, Berlin, Germany
Ulrike Westerhausen, Dr.
Pneumologisches Studienzentrum, Berlin, Germany
Oliver Kornmann, Dr.
IKF Pneumologie GmbH, Frankfurt, Germany
Jutta Beier, Dr. med.
Insaf GmbH, Wiesbaden, Germany
54 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2015
First Posted
June 24, 2015
Study Start
June 25, 2015
Actual (reported)Placebo once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3
58 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3
250 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3
800 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3
58 µg AZD7594 once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3
250 µg AZD7594 once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3
800 µg AZD7594 once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
Inhalation as needed
Contact the study team to confirm eligibility.
Research Site
Hamburg, 22143, Germany
Research Site
Lübeck, 23552, Germany
Research Site
Wiesbaden, 65187, Germany
Christine Grigat, Dr.
Clinical Research Hamburg GmbH, Hamburg, Germany
Andrea Ludwig-Sengpiel, Dr.
KLB Gesundheitsforschung Lübeck GmbH, Lübeck, Germany
Dirk Skowasch, Prof.
University hospital of Bonn, Department of Internal Medicine II, Bonn, Germany
Anne-Marie Kirsten, Dr.
Pneumologisches Forschungsinstitut an der LungenClinic Großhansdorf, Großhansdorf, Germany
Tanya Kralimarkova, Dr.
COMAC Medical Ltd., Sofia, Bulgaria
Anneliese Linnhoff, Dr. med.
Praxis für Lungen- und Bronchialheilkunde, Allergologie und Umweltmedizin
Margret Jandl, Dr.
Hamburger Institut für Therapie Forschung GmbH
Primary Completion
February 8, 2016
Actual (reported)Study Completion
February 8, 2016
Actual (reported)Last Updated
February 15, 2018
Results First Posted
June 23, 2017
Record last verified: 2017-08
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