Clinical trial NCT00736489: Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199
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 to Formoterol in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Airway Obstruction
Keywords: Asthma
airway obstruction
beta2-agonist
efficacy
inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: FEV1 Peak Effect Within 0 - 24 h Post-dose
timeFrame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
measure: E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
timeFrame: 22- 26 h post dose
measure: S-potassium, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 15min, 30min,1h, 2h, 4h
measure: S-potassium, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 15min, 30min,1h, 2h, 4h
Secondary outcomes:
measure: FEV1 Effect at 5 Min Post-dose
timeFrame: 5min
measure: FEV1 Average Effect Over 0 - 24 h Post-dose
timeFrame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
measure: FEV1 Average Effect Over 0 - 12 h Post-dose
timeFrame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h
measure: FEV1 Average Effect Over 12 - 24 h Post-dose
timeFrame: 12h, 14h, 18h, 22h, 24h
measure: Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Pulse, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Pulse, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Heart Rate, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Heart Rate, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: QTcB, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: QTcB, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 30min, 2h, 4h
measure: Tremor, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 15min, 30min, 1h, 2h, 4h
measure: Tremor, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 15min, 30min, 1h, 2h, 4h
measure: Palpitations, Peak Effect Over 0 - 4 h Post-dose
timeFrame: 0, 15min, 30min, 1h, 2h, 4h
measure: Palpitations, Average Effect Over 0 - 4 h Post-dose
timeFrame: 0, 15min, 30min, 1h, 2h, 4h
measure: Plasma AZD3199 Cmax
timeFrame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
measure: Plasma AZD3199 AUC0-24
timeFrame: 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Research Site
city: Gothenburg
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: University Hospital in Lund, Sweden
name: Prof Leif Bjermer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.