NCT01348139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 5, 2013

Completed
Last Updated

March 5, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

May 3, 2011

Results QC Date

January 28, 2013

Last Update Submit

January 28, 2013

Conditions

Asthma

Keywords

Asthmapatientslung function

Outcome Measures

Primary Outcomes (2)

  • Emax: Maximum Value of FEV1 for Every Treatment Visits

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

    0-24 hrs

  • 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.

    22-26 hrs.

Secondary Outcomes (9)

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

    0 - 24 hrs.

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

    FEV1 at 5 min

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

    0 - 24 hrs

  • Emax: Maximum Value of Pulse for Every Treatment Visits

    0 - 4 hrs.

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

    0 - 4 hrs.

  • +4 more secondary outcomes

Study Arms (6)

1

EXPERIMENTAL

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

Drug: AZD3199

2

EXPERIMENTAL

AZD3199 880 µg inhaled via SID, single dose

Drug: AZD3199

3

EXPERIMENTAL

AZD3199 1400 µg inhaled via SID, single dose

Drug: AZD3199

4

EXPERIMENTAL

AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose

Drug: AZD3199

5

EXPERIMENTAL

AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose

Drug: AZD3199

6

PLACEBO COMPARATOR

Placebo inhaled via Turbuhaler inhaler and SID, single dose

Other: AZD3199 Placebo

Interventions

AZD3199DRUG

Inhaled via single inhaler device (SID)

123
AZD3199 PlaceboOTHER

Inhaled via Turbuhaler inhaler and SID

6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Gothenburg, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Lund, Sweden

Location

MeSH Terms

Conditions

Asthma

Interventions

AZD-3199

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 5, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 5, 2013

Results First Posted

March 5, 2013

Record last verified: 2013-01

Locations

SE(3)