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Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

Primary Purpose

Asthma, Airway Obstruction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD3199
Formoterol
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, airway obstruction, beta2-agonist, efficacy, inhalation

Eligibility Criteria

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

Inclusion Criteria:

  • Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters.
  • Men and post-menopausal women above 18 years of age.
  • Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
  • Non/ex-smokers

Exclusion Criteria:

  • Any clinically significant disease or disorder other than asthma
  • Any clinically relevant abnormal findings at screening examinations
  • Treatment with systemic glucocorticosteroids within the past 30 days
  • Inhaled corticosteroid use if dosing is not kept constant

Sites / Locations

  • Research Site
  • 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

Experimental

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

crossover dose 1

crossover dose 2

crossover dose 3

crossover dose 4

crossover dose 5

crossover dose 6

Arm Description

AZD3199 120 microgram

AZD3199 480 microgram

AZD3199 1920 microgram

Placebo

Formoterol 9 microgram

Formoterol 36 microgram

Outcomes

Primary Outcome Measures

FEV1 Peak Effect Within 0 - 24 h Post-dose
Maximum FEV1 value
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
Residual FEV1 24 h post-dose
S-potassium, Peak Effect Over 0 - 4 h Post-dose
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
S-potassium, Average Effect Over 0 - 4 h Post-dose
Average S-potassium concentration

Secondary Outcome Measures

FEV1 Effect at 5 Min Post-dose
FEV1 at 5 minutes
FEV1 Average Effect Over 0 - 24 h Post-dose
FEV1 average effect over 24 h dosing interval
FEV1 Average Effect Over 0 - 12 h Post-dose
FEV1 average effect over 12 h day-time period
FEV1 Average Effect Over 12 - 24 h Post-dose
FEV1 average effect over 12 h night-time period
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Maximum SBP value over 4 h
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Average SBP value over 4 h
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Minimum DBP value over 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Average DBP value over 4 h
Pulse, Peak Effect Over 0 - 4 h Post-dose
Maximum pulse over 4 h
Pulse, Average Effect Over 0 - 4 h Post-dose
Average pulse over 4 h
Heart Rate, Peak Effect Over 0 - 4 h Post-dose
Maximum heart rate over 4 h
Heart Rate, Average Effect Over 0 - 4 h Post-dose
Average heart rate over 4 h
QTcB, Peak Effect Over 0 - 4 h Post-dose
Maximum QTc Bazett over 4 h
QTcB, Average Effect Over 0 - 4 h Post-dose
Average QTc Bazett over 4 h
Tremor, Peak Effect Over 0 - 4 h Post-dose
Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
Tremor, Average Effect Over 0 - 4 h Post-dose
Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
Palpitations, Peak Effect Over 0 - 4 h Post-dose
Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
Palpitations, Average Effect Over 0 - 4 h Post-dose
Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
Plasma AZD3199 Cmax
Maximum plasma concentration of AZD3199 measured
Plasma AZD3199 AUC0-24
Area under the plasma concentration curve from time 0 to 24 h post-dose

Full Information

First Posted
August 15, 2008
Last Updated
May 8, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00736489
Brief Title
Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199
Official Title
A Phase II, Double-blind, Placebo-controlled, Randomised, 6-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of 3 Doses of Inhaled AZD3199 (a β2-agonist) Compared to Formoterol in Asthmatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Airway Obstruction
Keywords
Asthma, airway obstruction, beta2-agonist, efficacy, inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
crossover dose 1
Arm Type
Experimental
Arm Description
AZD3199 120 microgram
Arm Title
crossover dose 2
Arm Type
Experimental
Arm Description
AZD3199 480 microgram
Arm Title
crossover dose 3
Arm Type
Experimental
Arm Description
AZD3199 1920 microgram
Arm Title
crossover dose 4
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
crossover dose 5
Arm Type
Active Comparator
Arm Description
Formoterol 9 microgram
Arm Title
crossover dose 6
Arm Type
Active Comparator
Arm Description
Formoterol 36 microgram
Intervention Type
Drug
Intervention Name(s)
AZD3199
Intervention Description
Dry powder for inhalation, single dose
Intervention Type
Drug
Intervention Name(s)
Formoterol
Other Intervention Name(s)
Oxis
Intervention Description
Dry powder for inhalation, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dry powder for inhalation, single dose
Primary Outcome Measure Information:
Title
FEV1 Peak Effect Within 0 - 24 h Post-dose
Description
Maximum FEV1 value
Time Frame
0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
Title
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
Description
Residual FEV1 24 h post-dose
Time Frame
22- 26 h post dose
Title
S-potassium, Peak Effect Over 0 - 4 h Post-dose
Description
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
Time Frame
0, 15min, 30min,1h, 2h, 4h
Title
S-potassium, Average Effect Over 0 - 4 h Post-dose
Description
Average S-potassium concentration
Time Frame
0, 15min, 30min,1h, 2h, 4h
Secondary Outcome Measure Information:
Title
FEV1 Effect at 5 Min Post-dose
Description
FEV1 at 5 minutes
Time Frame
5min
Title
FEV1 Average Effect Over 0 - 24 h Post-dose
Description
FEV1 average effect over 24 h dosing interval
Time Frame
0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
Title
FEV1 Average Effect Over 0 - 12 h Post-dose
Description
FEV1 average effect over 12 h day-time period
Time Frame
0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h
Title
FEV1 Average Effect Over 12 - 24 h Post-dose
Description
FEV1 average effect over 12 h night-time period
Time Frame
12h, 14h, 18h, 22h, 24h
Title
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Description
Maximum SBP value over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Description
Average SBP value over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
Description
Minimum DBP value over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
Description
Average DBP value over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Pulse, Peak Effect Over 0 - 4 h Post-dose
Description
Maximum pulse over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Pulse, Average Effect Over 0 - 4 h Post-dose
Description
Average pulse over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Heart Rate, Peak Effect Over 0 - 4 h Post-dose
Description
Maximum heart rate over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Heart Rate, Average Effect Over 0 - 4 h Post-dose
Description
Average heart rate over 4 h
Time Frame
0, 30min, 2h, 4h
Title
QTcB, Peak Effect Over 0 - 4 h Post-dose
Description
Maximum QTc Bazett over 4 h
Time Frame
0, 30min, 2h, 4h
Title
QTcB, Average Effect Over 0 - 4 h Post-dose
Description
Average QTc Bazett over 4 h
Time Frame
0, 30min, 2h, 4h
Title
Tremor, Peak Effect Over 0 - 4 h Post-dose
Description
Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
Time Frame
0, 15min, 30min, 1h, 2h, 4h
Title
Tremor, Average Effect Over 0 - 4 h Post-dose
Description
Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.
Time Frame
0, 15min, 30min, 1h, 2h, 4h
Title
Palpitations, Peak Effect Over 0 - 4 h Post-dose
Description
Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
Time Frame
0, 15min, 30min, 1h, 2h, 4h
Title
Palpitations, Average Effect Over 0 - 4 h Post-dose
Description
Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
Time Frame
0, 15min, 30min, 1h, 2h, 4h
Title
Plasma AZD3199 Cmax
Description
Maximum plasma concentration of AZD3199 measured
Time Frame
0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
Title
Plasma AZD3199 AUC0-24
Description
Area under the plasma concentration curve from time 0 to 24 h post-dose
Time Frame
0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters. Men and post-menopausal women above 18 years of age. Reversible airway obstruction in response to classical beta2-agonist (salbutamol) Non/ex-smokers Exclusion Criteria: Any clinically significant disease or disorder other than asthma Any clinically relevant abnormal findings at screening examinations Treatment with systemic glucocorticosteroids within the past 30 days Inhaled corticosteroid use if dosing is not kept constant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Leif Bjermer, MD, PhD
Organizational Affiliation
University Hospital in Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
Gothenburg
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23907810
Citation
Bjermer L, Rosenborg J, Bengtsson T, Lotvall J. Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting beta(2)-adrenoceptor agonist, with formoterol in patients with asthma. Ther Adv Respir Dis. 2013 Oct;7(5):264-71. doi: 10.1177/1753465813497527. Epub 2013 Aug 1.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=238&filename=CSR-D0570C00007.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=238&filename=D0570C00007.pdf
Description
D0570C00007 CSR Synopsis

Learn more about this trial

Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

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