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Completed

NCT Number: NCT00736489

Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

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

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Key information

Conditions

Asthma Airway Obstruction Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Hvidovre, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3199

Drug

Dry powder for inhalation, single dose

Formoterol

Drug

Dry powder for inhalation, single dose

Other names: Oxis

Placebo

Drug

Dry powder for inhalation, single dose

Primary outcomes

  1. 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

  2. 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

  3. 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.

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

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

    Average S-potassium concentration

Secondary outcomes

  1. FEV1 Effect at 5 Min Post-dose

    Time frame: 5min

    FEV1 at 5 minutes

  2. 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

  3. 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

  4. 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

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

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

    Maximum SBP value over 4 h

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

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

    Average SBP value over 4 h

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

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

    Minimum DBP value over 4 h

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

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

    Average DBP value over 4 h

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

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

    Maximum pulse over 4 h

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

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

    Average pulse over 4 h

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

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

    Maximum heart rate over 4 h

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

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

    Average heart rate over 4 h

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

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

    Maximum QTc Bazett over 4 h

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

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

    Average QTc Bazett over 4 h

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. Plasma AZD3199 Cmax

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

    Maximum plasma concentration of AZD3199 measured

  20. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 18, 2008
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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