Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

Phase 2CompletedNCT00736489

AstraZeneca37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma Airway Obstruction

Interventions

AZD3199DRUG

Dry powder for inhalation, single dose

FormoterolDRUG

Dry powder for inhalation, single dose

PlaceboDRUG

Dry powder for inhalation, single dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Research Site

Hvidovre, Denmark

Research Site

Gothenburg, Sweden

Research Site

Luleå, Sweden

Research Site

Lund, Sweden

Outcomes

Primary Outcomes

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

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

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

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

Average S-potassium concentration

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

Secondary Outcomes

FEV1 Effect at 5 Min Post-dose

FEV1 at 5 minutes

Time frame: 5min

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

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

FEV1 Average Effect Over 12 - 24 h Post-dose

FEV1 average effect over 12 h night-time period

Data from ClinicalTrials.gov

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

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

Maximum SBP value over 4 h

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

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

Average SBP value over 4 h

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

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

Minimum DBP value over 4 h

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

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

Average DBP value over 4 h

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

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

Maximum pulse over 4 h

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

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

Average pulse over 4 h

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

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

Maximum heart rate over 4 h

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

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

Average heart rate over 4 h

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

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

Maximum QTc Bazett over 4 h

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

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

Average QTc Bazett over 4 h

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

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

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

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

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

Plasma AZD3199 Cmax

Maximum plasma concentration of AZD3199 measured

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

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