Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

AZD3199 800 µg inhaled via single inhaler device (SID), single dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Inhaled via single inhaler device (SID)

2

AZD3199 880 µg inhaled via SID, single dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Inhaled via single inhaler device (SID)

3

AZD3199 1400 µg inhaled via SID, single dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Inhaled via single inhaler device (SID)

4

AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Inhaled via Turbuhaler inhaler

5

AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Inhaled via Turbuhaler inhaler

6

Placebo inhaled via Turbuhaler inhaler and SID, single dose

Group Type PLACEBO_COMPARATOR

AZD3199 Placebo

Intervention Type OTHER

Inhaled via Turbuhaler inhaler and SID

Interventions

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AZD3199

Inhaled via single inhaler device (SID)

Intervention Type DRUG

AZD3199

Inhaled via Turbuhaler inhaler

Intervention Type DRUG

AZD3199 Placebo

Inhaled via Turbuhaler inhaler and SID

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated written informed consent prior to any study specific procedures
* Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to study start
* A history of asthma for at least 6 months.
* Body Mass Index (BMI) 19-30 kg/m2

Exclusion Criteria

* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients
* Prolonged QTcF \> 450 msec or shortened QTcF \<340 msec
* History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No