Clinical Trial: Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 t

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

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

• FEV1 Peak Effect Within 0 - 24 h Post-dose [ Time Frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h ]
  Maximum FEV1 value
• E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit. [ Time Frame: 22- 26 h post dose ]
  Residual FEV1 24 h post-dose
• S-potassium, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 15min, 30min,1h, 2h, 4h ]
  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 [ Time Frame: 0, 15min, 30min,1h, 2h, 4h ]
  Average S-potassium concentration

Original Primary Outcome: Potassium serum concentration [ Time Frame: Before and up to 24 h after dosing. 6 assessments per dose. ]

Current Secondary Outcome:

• FEV1 Effect at 5 Min Post-dose [ Time Frame: 5min ]
  FEV1 at 5 minutes
• FEV1 Average Effect Over 0 - 24 h Post-dose [ Time Frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h ]
  FEV1 average effect over 24 h dosing interval
• FEV1 Average Effect Over 0 - 12 h Post-dose [ Time Frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h ]
  FEV1 average effect over 12 h day-time period
• FEV1 Average Effect Over 12 - 24 h Post-dose [ Time Frame: 12h, 14h, 18h, 22h, 24h ]
  FEV1 average effect over 12 h night-time period
• Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Maximum SBP value over 4 h
• Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Average SBP value over 4 h
• Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Minimum DBP value over 4 h
• Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Average DBP value over 4 h
• Pulse, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Maximum pulse over 4 h
• Pulse, Average Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Average pulse over 4 h
• Heart Rate, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Maximum heart rate over 4 h
• Heart Rate, Average Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Average heart rate over 4 h
• QTcB, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Maximum QTc Bazett over 4 h
• QTcB, Average Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 30min, 2h, 4h ]
  Average QTc Bazett over 4 h
• Tremor, Peak Effect Over 0 - 4 h Post-dose [ Time Frame: 0, 15min, 30min, 1h, 2h, 4h ]
  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 [ Time Frame: 0, 15min, 30min, 1h, 2h, 4h ]
  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 [ Time Frame: 0, 15min, 30min, 1h, 2h, 4h ]
  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 [ Time Frame: 0, 15min, 30min, 1h, 2h, 4h ]
  Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h
• Plasma AZD3199 Cmax [ Time Frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h ]
  Maximum plasma concentration of AZD3199 measured
• Plasma AZD3199 AUC0-24 [ Time Frame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h ]
  Area under the plasma concentration curve from time 0 to 24 h post-dose

Original Secondary Outcome:

• Forced Expiratory Volume in first second [ Time Frame: Before and up to 26 h after dosing. 17 assessments per dose. ]
• Drug exposure and pharmacokinetics [ Time Frame: Before and up to 24 h after dosing. 10 assessments per dose. ]
• Incidence and nature of adverse events, clinical laboratory assessments, and physical examination [ Time Frame: Before and up to 24 h after dosing. 2 assessments per dose. ]
• Tremor, palpitations, heart rate, QTc, pulse and blood pressure [ Time Frame: Before and after dosing. 7 assessments per dose. ]

Information By: AstraZeneca

Dates:
Date Received: August 15, 2008
Date Started: August 2008
Date Completion:
Last Updated: May 8, 2014
Last Verified: April 2014