Phase 2 N=37 Randomized Quadruple-blind Treatment

Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

Asthma · Airway Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT00736489 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: FEV1 Peak Effect Within 0 - 24 h Post-dose — 3.56; 3.62; 3.70; 3.62 L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD3199 (Drug); Formoterol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY FEV1 Peak Effect Within 0 - 24 h Post-dose	3.56; 3.62; 3.70; 3.62; 3.69; 3.44	—
PRIMARY E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.	3.31; 3.35; 3.40; 3.26; 3.36; 3.23	—
PRIMARY S-potassium, Peak Effect Over 0 - 4 h Post-dose	4.04; 4.03; 3.98; 4.04; 3.84; 4.04	—
PRIMARY S-potassium, Average Effect Over 0 - 4 h Post-dose	4.22; 4.21; 4.17; 4.19; 3.99; 4.21	—
SECONDARY FEV1 Effect at 5 Min Post-dose	3.36; 3.38; 3.33; 3.37; 3.47; 3.13	—
SECONDARY FEV1 Average Effect Over 0 - 24 h Post-dose	3.31; 3.36; 3.44; 3.35; 3.46; 3.19	—
SECONDARY FEV1 Average Effect Over 0 - 12 h Post-dose	3.33; 3.40; 3.48; 3.40; 3.51; 3.20	—
SECONDARY FEV1 Average Effect Over 12 - 24 h Post-dose	3.28; 3.33; 3.41; 3.30; 3.40; 3.19	—
SECONDARY Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose	126.8; 128.3; 127.4; 127.3; 129.9; 126.4	—
SECONDARY Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose	121.1; 121.8; 121.3; 120.9; 122.6; 121.3	—
SECONDARY Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose	67.3; 67.6; 66.7; 66.9; 66.7; 68.8	—
SECONDARY Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose	71.4; 72.0; 71.6; 71.5; 71.0; 72.7	—
SECONDARY Pulse, Peak Effect Over 0 - 4 h Post-dose	62.1; 65.0; 66.7; 63.6; 67.3; 65.3	—
SECONDARY Pulse, Average Effect Over 0 - 4 h Post-dose	57.1; 59.0; 61.9; 58.6; 62.8; 58.8	—
SECONDARY Heart Rate, Peak Effect Over 0 - 4 h Post-dose	64.0; 64.1; 66.9; 63.8; 66.8; 64.5	—
SECONDARY Heart Rate, Average Effect Over 0 - 4 h Post-dose	58.3; 59.0; 61.8; 58.6; 62.7; 58.1	—
SECONDARY QTcB, Peak Effect Over 0 - 4 h Post-dose	412; 407; 413; 408; 415; 408	—
SECONDARY QTcB, Average Effect Over 0 - 4 h Post-dose	398; 397; 402; 395; 406; 395	—
SECONDARY Tremor, Peak Effect Over 0 - 4 h Post-dose	0.06; 0.06; 0.17; 0.11; 0.47; 0.03	—
SECONDARY Tremor, Average Effect Over 0 - 4 h Post-dose	0.00; 0.02; 0.04; 0.05; 0.16; 0.01	—
SECONDARY Palpitations, Peak Effect Over 0 - 4 h Post-dose	0.03; 0.03; 0.09; 0.00; 0.18; 0.00	—
SECONDARY Palpitations, Average Effect Over 0 - 4 h Post-dose	0.00; 0.01; 0.02; 0.00; 0.11; 0.00	—
SECONDARY Plasma AZD3199 Cmax	0.99; 5.39; 24.55	—
SECONDARY Plasma AZD3199 AUC0-24	1.83; 9.75; 46.06	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00736489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.