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

Summary

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.

Conditions

• Asthma
• Efficacy
• Safety

Interventions

DRUG

800 μg AZD7594 once daily

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

DRUG

250 µg AZD7594 once daily

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

DRUG

58 µg AZD7594 once daily

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

DRUG

Placebo once daily

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

DRUG

Salbutamol

Inhalation as needed

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-25

Primary Completion

2016-02-08

Completion

2016-02-08

Countries

• Bulgaria
• Germany

Study Locations