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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

AZD3199

AZD3199 Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, patients, lung function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

AZD3199 880 µg inhaled via SID, single dose

AZD3199 1400 µg inhaled via SID, single dose

AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose

AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose

Placebo inhaled via Turbuhaler inhaler and SID, single dose

Outcomes

Primary Outcome Measures

Emax: Maximum Value of FEV1 for Every Treatment Visits

Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.

E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit

Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.

Secondary Outcome Measures

tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit

Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.

E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.

Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.

E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit

Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.

Emax: Maximum Value of Pulse for Every Treatment Visits

Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.

E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit

Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.

Cmax: Maximum Plasma Concentration

Maximum plasma concentration (Cmax) for AZD3199 doses

AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),

Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses

Tmax:Time to Maximum Plasma Concentration

Time to maximum plasma concentration (tmax), for AZD3199 doses

t1/2 :Terminal Half-life

Terminal half-life (t1/2),for AZD3199 doses

Full Information

NCT ID

NCT01348139

First Posted

May 3, 2011

Last Updated

January 28, 2013

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01348139

Brief Title

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

Official Title

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered Via Single Inhalation Device Compared to AZD3199 Administered Via Turbuhaler™ Inhaler in Patients With Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, patients, lung function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

AZD3199 880 µg inhaled via SID, single dose

Arm Title

Arm Type

Experimental

Arm Description

AZD3199 1400 µg inhaled via SID, single dose

Arm Title

Arm Type

Experimental

Arm Description

AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose

Arm Title

Arm Type

Experimental

Arm Description

AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo inhaled via Turbuhaler inhaler and SID, single dose

Intervention Type

Drug

Intervention Name(s)

AZD3199

Intervention Description

Inhaled via single inhaler device (SID)

Intervention Type

Drug

Intervention Name(s)

AZD3199

Intervention Description

Inhaled via Turbuhaler inhaler

Intervention Type

Other

Intervention Name(s)

AZD3199 Placebo

Intervention Description

Inhaled via Turbuhaler inhaler and SID

Primary Outcome Measure Information:

Title

Emax: Maximum Value of FEV1 for Every Treatment Visits

Description

Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.

Time Frame

0-24 hrs

Title

E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit

Description

Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.

Time Frame

22-26 hrs.

Secondary Outcome Measure Information:

Title

tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit

Description

Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.

Time Frame

0 - 24 hrs.

Title

E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.

Description

Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.

Time Frame

FEV1 at 5 min

Title

E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit

Description

Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.

Time Frame

0 - 24 hrs

Title

Emax: Maximum Value of Pulse for Every Treatment Visits

Description

Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.

Time Frame

0 - 4 hrs.

Title

E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit

Description

Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.

Time Frame

0 - 4 hrs.

Title

Cmax: Maximum Plasma Concentration

Description

Maximum plasma concentration (Cmax) for AZD3199 doses

Time Frame

0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Title

AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),

Description

Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses

Time Frame

0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Title

Tmax:Time to Maximum Plasma Concentration

Description

Time to maximum plasma concentration (tmax), for AZD3199 doses

Time Frame

0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

Title

t1/2 :Terminal Half-life

Description

Terminal half-life (t1/2),for AZD3199 doses

Time Frame

0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Research Site

City

Göteborg

Country

Sweden

Facility Name

Research Site

City

Luleå

Country

Sweden

Facility Name

Research Site

City

Lund

Country

Sweden

12. IPD Sharing Statement

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

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