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CompletedNCT00736489Updated May 19, 2014Results posted

Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

A Phase 2 interventional study of AZD3199 and Formoterol in Asthma and Airway Obstruction, sponsored by AstraZeneca. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-19.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma
  • Airway Obstruction

Browse trials for

Keywords

  • Asthma
  • airway obstruction
  • beta2-agonist
  • efficacy
  • inhalation
03

In context

Airway Obstruction

154 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.

This study's enrollment of 37 is below the median of 56 across 92 interventional studies indexed under Airway Obstruction.

Browse Airway Obstruction studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    crossover dose 1

    AZD3199 120 microgram

    Drug: AZD3199

  • Experimental
    crossover dose 2

    AZD3199 480 microgram

    Drug: AZD3199

  • Experimental
    crossover dose 3

    AZD3199 1920 microgram

    Drug: AZD3199

  • Placebo comparator
    crossover dose 4

    Placebo

    Drug: Placebo

  • Active comparator
    crossover dose 5

    Formoterol 9 microgram

    Drug: Formoterol

  • Active comparator
    crossover dose 6

    Formoterol 36 microgram

    Drug: Formoterol

Interventions

  • DrugAZD3199

    Dry powder for inhalation, single dose

  • DrugFormoterol

    Dry powder for inhalation, single dose

    Also known as: Oxis

  • DrugPlacebo

    Dry powder for inhalation, single dose

06

What researchers measure

Primary outcomes

  1. FEV1 Peak Effect Within 0 - 24 h Post-dose

    Maximum FEV1 value

    Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h

  2. 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

    Time frame: 22- 26 h post dose

  3. 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.

    Time frame: 0, 15min, 30min,1h, 2h, 4h

  4. S-potassium, Average Effect Over 0 - 4 h Post-dose

    Average S-potassium concentration

    Time frame: 0, 15min, 30min,1h, 2h, 4h

Secondary outcomes

  1. FEV1 Effect at 5 Min Post-dose

    FEV1 at 5 minutes

    Time frame: 5min

  2. FEV1 Average Effect Over 0 - 24 h Post-dose

    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

  3. FEV1 Average Effect Over 0 - 12 h Post-dose

    FEV1 average effect over 12 h day-time period

    Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h

  4. FEV1 Average Effect Over 12 - 24 h Post-dose

    FEV1 average effect over 12 h night-time period

    Time frame: 12h, 14h, 18h, 22h, 24h

  5. Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose

    Maximum SBP value over 4 h

    Time frame: 0, 30min, 2h, 4h

  6. Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose

    Average SBP value over 4 h

    Time frame: 0, 30min, 2h, 4h

  7. Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose

    Minimum DBP value over 4 h

    Time frame: 0, 30min, 2h, 4h

  8. Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose

    Average DBP value over 4 h

    Time frame: 0, 30min, 2h, 4h

  9. Pulse, Peak Effect Over 0 - 4 h Post-dose

    Maximum pulse over 4 h

    Time frame: 0, 30min, 2h, 4h

  10. Pulse, Average Effect Over 0 - 4 h Post-dose

    Average pulse over 4 h

    Time frame: 0, 30min, 2h, 4h

  11. Heart Rate, Peak Effect Over 0 - 4 h Post-dose

    Maximum heart rate over 4 h

    Time frame: 0, 30min, 2h, 4h

  12. Heart Rate, Average Effect Over 0 - 4 h Post-dose

    Average heart rate over 4 h

    Time frame: 0, 30min, 2h, 4h

  13. QTcB, Peak Effect Over 0 - 4 h Post-dose

    Maximum QTc Bazett over 4 h

    Time frame: 0, 30min, 2h, 4h

  14. QTcB, Average Effect Over 0 - 4 h Post-dose

    Average QTc Bazett over 4 h

    Time frame: 0, 30min, 2h, 4h

  15. 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.

    Time frame: 0, 15min, 30min, 1h, 2h, 4h

  16. 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.

    Time frame: 0, 15min, 30min, 1h, 2h, 4h

  17. 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

    Time frame: 0, 15min, 30min, 1h, 2h, 4h

  18. 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

    Time frame: 0, 15min, 30min, 1h, 2h, 4h

  19. Plasma AZD3199 Cmax

    Maximum plasma concentration of AZD3199 measured

    Time frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h

  20. Plasma AZD3199 AUC0-24

    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

07

Results

Posted Apr 3, 2014

Participant flow

The study has been performed in Sweden and Denmark at two University hospital clinics and two CROs. The recruitment period was between 11 August 2008 to 22 October 2008.

Period 1
Participant flow — Period 1
MilestoneAPCDEBaBADEPCaCBEPADaDCPABEaEDABCPaPEBCDAa
Started656776
Completed556775
Not completed100001
Withdrew: Lost to follow-up100000
Withdrew: Withdrawal by subject000001
Period 2
Participant flow — Period 2
MilestoneAPCDEBaBADEPCaCBEPADaDCPABEaEDABCPaPEBCDAa
Started556775
Completed556775
Not completed000000
Period 3
Participant flow — Period 3
MilestoneAPCDEBaBADEPCaCBEPADaDCPABEaEDABCPaPEBCDAa
Started556775
Completed556775
Not completed000000
Period 4
Participant flow — Period 4
MilestoneAPCDEBaBADEPCaCBEPADaDCPABEaEDABCPaPEBCDAa
Started556775
Completed556775
Not completed000000
Period 5
Participant flow — Period 5
MilestoneAPCDEBaBADEPCaCBEPADaDCPABEaEDABCPaPEBCDAa
Started556775
Completed556775
Not completed000000
Period 6
Participant flow — Period 6
MilestoneAPCDEBaBADEPCaCBEPADaDCPABEaEDABCPaPEBCDAa
Started556775
Completed556775
Not completed000000

Outcome measures

PrimaryFEV1 Peak Effect Within 0 - 24 h Post-dose

Maximum FEV1 value

Time frame:
0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
Reported as:
Mean · L
FEV1 Peak Effect Within 0 - 24 h Post-dose
LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
FEV1 Peak Effect Within 0 - 24 h Post-dose3.56 ± 0.943.62 ± 0.943.70 ± 1.023.62 ± 1.013.69 ± 0.973.44 ± 0.99
PrimaryE22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.

Residual FEV1 24 h post-dose

Time frame:
22- 26 h post dose
Reported as:
Mean · L
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.3.31 ± 0.963.35 ± 0.933.40 ± 0.943.26 ± 0.943.36 ± 0.973.23 ± 0.96
PrimaryS-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.

Time frame:
0, 15min, 30min,1h, 2h, 4h
Reported as:
Mean · mmol/L
S-potassium, Peak Effect Over 0 - 4 h Post-dose
mmol/LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
S-potassium, Peak Effect Over 0 - 4 h Post-dose4.04 ± 0.194.03 ± 0.253.98 ± 0.284.04 ± 0.203.84 ± 0.214.04 ± 0.23
PrimaryS-potassium, Average Effect Over 0 - 4 h Post-dose

Average S-potassium concentration

Time frame:
0, 15min, 30min,1h, 2h, 4h
Reported as:
Mean · mmol/L
S-potassium, Average Effect Over 0 - 4 h Post-dose
mmol/LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
S-potassium, Average Effect Over 0 - 4 h Post-dose4.22 ± 0.194.21 ± 0.264.17 ± 0.264.19 ± 0.203.99 ± 0.174.21 ± 0.25
SecondaryFEV1 Effect at 5 Min Post-dose

FEV1 at 5 minutes

Time frame:
5min
Reported as:
Mean · L
FEV1 Effect at 5 Min Post-dose
LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
FEV1 Effect at 5 Min Post-dose3.36 ± 0.883.38 ± 0.923.33 ± 1.033.37 ± 0.953.47 ± 0.933.13 ± 0.86
SecondaryFEV1 Average Effect Over 0 - 24 h Post-dose

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
Reported as:
Mean · L
FEV1 Average Effect Over 0 - 24 h Post-dose
LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
FEV1 Average Effect Over 0 - 24 h Post-dose3.31 ± 0.933.36 ± 0.913.44 ± 0.953.35 ± 0.983.46 ± 0.963.19 ± 0.95
SecondaryFEV1 Average Effect Over 0 - 12 h Post-dose

FEV1 average effect over 12 h day-time period

Time frame:
0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h
Reported as:
Mean · L
FEV1 Average Effect Over 0 - 12 h Post-dose
LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
FEV1 Average Effect Over 0 - 12 h Post-dose3.33 ± 0.923.40 ± 0.893.48 ± 0.973.40 ± 0.983.51 ± 0.953.20 ± 0.96
SecondaryFEV1 Average Effect Over 12 - 24 h Post-dose

FEV1 average effect over 12 h night-time period

Time frame:
12h, 14h, 18h, 22h, 24h
Reported as:
Mean · L
FEV1 Average Effect Over 12 - 24 h Post-dose
LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
FEV1 Average Effect Over 12 - 24 h Post-dose3.28 ± 0.953.33 ± 0.923.41 ± 0.943.30 ± 0.983.40 ± 0.983.19 ± 0.95
SecondarySystolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose

Maximum SBP value over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · mmHg
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
mmHgAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose126.8 ± 14.5128.3 ± 13.4127.4 ± 12.0127.3 ± 13.2129.9 ± 12.1126.4 ± 14.4
SecondarySystolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose

Average SBP value over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · mmHg
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
mmHgAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose121.1 ± 13.7121.8 ± 11.8121.3 ± 11.9120.9 ± 12.8122.6 ± 11.8121.3 ± 13.5
SecondaryDiastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose

Minimum DBP value over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · mmHg
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
mmHgAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose67.3 ± 10.367.6 ± 7.966.7 ± 9.666.9 ± 9.166.7 ± 9.668.8 ± 8.0
SecondaryDiastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose

Average DBP value over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · mmHg
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
mmHgAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose71.4 ± 10.072.0 ± 8.971.6 ± 9.571.5 ± 9.271.0 ± 8.672.7 ± 8.4
SecondaryPulse, Peak Effect Over 0 - 4 h Post-dose

Maximum pulse over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · bpm
Pulse, Peak Effect Over 0 - 4 h Post-dose
bpmAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Pulse, Peak Effect Over 0 - 4 h Post-dose62.1 ± 9.465.0 ± 11.066.7 ± 9.963.6 ± 11.067.3 ± 11.665.3 ± 10.4
SecondaryPulse, Average Effect Over 0 - 4 h Post-dose

Average pulse over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · bpm
Pulse, Average Effect Over 0 - 4 h Post-dose
bpmAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Pulse, Average Effect Over 0 - 4 h Post-dose57.1 ± 8.059.0 ± 8.761.9 ± 9.158.6 ± 9.462.8 ± 10.158.8 ± 8.8
SecondaryHeart Rate, Peak Effect Over 0 - 4 h Post-dose

Maximum heart rate over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · bpm
Heart Rate, Peak Effect Over 0 - 4 h Post-dose
bpmAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Heart Rate, Peak Effect Over 0 - 4 h Post-dose64.0 ± 8.864.1 ± 9.666.9 ± 9.563.8 ± 10.266.8 ± 10.964.5 ± 11.3
SecondaryHeart Rate, Average Effect Over 0 - 4 h Post-dose

Average heart rate over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · bpm
Heart Rate, Average Effect Over 0 - 4 h Post-dose
bpmAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Heart Rate, Average Effect Over 0 - 4 h Post-dose58.3 ± 7.959.0 ± 8.561.8 ± 9.058.6 ± 9.262.7 ± 10.058.1 ± 8.6
SecondaryQTcB, Peak Effect Over 0 - 4 h Post-dose

Maximum QTc Bazett over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · ms
QTcB, Peak Effect Over 0 - 4 h Post-dose
msAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
QTcB, Peak Effect Over 0 - 4 h Post-dose412 ± 21.6407 ± 22.8413 ± 22.0408 ± 21.6415 ± 24.6408 ± 20.8
SecondaryQTcB, Average Effect Over 0 - 4 h Post-dose

Average QTc Bazett over 4 h

Time frame:
0, 30min, 2h, 4h
Reported as:
Mean · ms
QTcB, Average Effect Over 0 - 4 h Post-dose
msAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
QTcB, Average Effect Over 0 - 4 h Post-dose398 ± 19.9397 ± 22.3402 ± 21.2395 ± 21.4406 ± 24.4395 ± 19.8
SecondaryTremor, 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.

Time frame:
0, 15min, 30min, 1h, 2h, 4h
Reported as:
Mean · Score on a scale
Tremor, Peak Effect Over 0 - 4 h Post-dose
Score on a scaleAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Tremor, Peak Effect Over 0 - 4 h Post-dose0.06 ± 0.240.06 ± 0.240.17 ± 0.450.11 ± 0.320.47 ± 0.660.03 ± 0.17
SecondaryTremor, 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.

Time frame:
0, 15min, 30min, 1h, 2h, 4h
Reported as:
Mean · Score on a scale
Tremor, Average Effect Over 0 - 4 h Post-dose
Score on a scaleAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Tremor, Average Effect Over 0 - 4 h Post-dose0.00 ± 0.020.02 ± 0.080.04 ± 0.110.05 ± 0.180.16 ± 0.340.01 ± 0.06
SecondaryPalpitations, 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

Time frame:
0, 15min, 30min, 1h, 2h, 4h
Reported as:
Mean · Score on a scale
Palpitations, Peak Effect Over 0 - 4 h Post-dose
Score on a scaleAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Palpitations, Peak Effect Over 0 - 4 h Post-dose0.03 ± 0.170.03 ± 0.170.09 ± 0.370.00 ± 0.000.18 ± 0.520.00 ± 0.00
SecondaryPalpitations, 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

Time frame:
0, 15min, 30min, 1h, 2h, 4h
Reported as:
Mean · Score on a scale
Palpitations, Average Effect Over 0 - 4 h Post-dose
Score on a scaleAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Palpitations, Average Effect Over 0 - 4 h Post-dose0.00 ± 0.020.01 ± 0.050.02 ± 0.080.00 ± 0.000.11 ± 0.330.00 ± 0.00
SecondaryPlasma AZD3199 Cmax

Maximum plasma concentration of AZD3199 measured

Time frame:
0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
Reported as:
Geometric mean · nmol/L
Plasma AZD3199 Cmax
nmol/LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Plasma AZD3199 Cmax0.99 (0.21 to 2.83)5.39 (1.32 to 12.4)24.55 (8.99 to 44.3)———
SecondaryPlasma AZD3199 AUC0-24

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
Reported as:
Geometric mean · nmol*h/L
Plasma AZD3199 AUC0-24
nmol*h/LAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
Plasma AZD3199 AUC0-241.83 (0.3 to 5.2)9.75 (2.9 to 23.5)46.06 (14.6 to 106.2)———

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD3199 120 mcg—0/36 (0%)4/36 (11.1%)
AZD3199 480 mcg—0/35 (0%)3/35 (8.6%)
AZD3199 1920 mcg—0/35 (0%)10/35 (28.6%)
Formoterol 9 mcg—0/35 (0%)2/35 (5.7%)
Formoterol 36 mcg—0/35 (0%)4/35 (11.4%)
Placebo—0/36 (0%)6/36 (16.7%)
Most frequent other events
Most frequent other events
EventAZD3199 120 mcgAZD3199 480 mcgAZD3199 1920 mcgFormoterol 9 mcgFormoterol 36 mcgPlacebo
HeadacheNervous system disorders1/363/354/352/353/352/36
NasopharyngitisInfections and infestations3/361/354/350/351/354/36
Throat irritationRespiratory, thoracic and mediastinal disorders0/360/354/350/350/350/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)Baseline Total
Mean40.3 (22 to 68)
Sex: Female, Male
Sex: Female, Male(Participants)Baseline Total
Female5
Male32
08

Study locations

4 sites
  • Research Site
    Hvidovre, Denmark
  • Research Site
    Gothenburg, Sweden
  • Research Site
    Lulea, Sweden
  • Research Site
    Lund, Sweden
09

References and documents

Publications

  • 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. PubMed 23907810 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00736489
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 18, 2008
Start date
Aug 2008
Primary completion
Dec 2008
Completion
Dec 2008
Results posted
Apr 3, 2014
Last update
May 19, 2014

Study contacts

Prof Leif Bjermer, MD, PhD
principal investigator · University Hospital in Lund, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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