Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736489
• Other study ID #: D0570C00007
• Secondary ID: ToBe
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2008
• Last updated: May 8, 2014
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardDenmark: Danish Medicines AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Asthma

Intervention

Drug:
• AZD3199
Dry powder for inhalation, single dose
• Formoterol
Dry powder for inhalation, single dose
• Placebo
Dry powder for inhalation, single dose

Locations

Country	Name	City	State
Denmark	Research Site	Hvidovre
Sweden	Research Site	Gothenburg
Sweden	Research Site	Lulea
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 Peak Effect Within 0 - 24 h Post-dose	Maximum FEV1 value	0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h	No
Primary	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	22- 26 h post dose	No
Primary	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.	0, 15min, 30min,1h, 2h, 4h	No
Primary	S-potassium, Average Effect Over 0 - 4 h Post-dose	Average S-potassium concentration	0, 15min, 30min,1h, 2h, 4h	No
Secondary	FEV1 Effect at 5 Min Post-dose	FEV1 at 5 minutes	5min	No
Secondary	FEV1 Average Effect Over 0 - 24 h Post-dose	FEV1 average effect over 24 h dosing interval	0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h	No
Secondary	FEV1 Average Effect Over 0 - 12 h Post-dose	FEV1 average effect over 12 h day-time period	0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h	No
Secondary	FEV1 Average Effect Over 12 - 24 h Post-dose	FEV1 average effect over 12 h night-time period	12h, 14h, 18h, 22h, 24h	No
Secondary	Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose	Maximum SBP value over 4 h	0, 30min, 2h, 4h	No
Secondary	Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose	Average SBP value over 4 h	0, 30min, 2h, 4h	No
Secondary	Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose	Minimum DBP value over 4 h	0, 30min, 2h, 4h	No
Secondary	Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose	Average DBP value over 4 h	0, 30min, 2h, 4h	No
Secondary	Pulse, Peak Effect Over 0 - 4 h Post-dose	Maximum pulse over 4 h	0, 30min, 2h, 4h	No
Secondary	Pulse, Average Effect Over 0 - 4 h Post-dose	Average pulse over 4 h	0, 30min, 2h, 4h	No
Secondary	Heart Rate, Peak Effect Over 0 - 4 h Post-dose	Maximum heart rate over 4 h	0, 30min, 2h, 4h	No
Secondary	Heart Rate, Average Effect Over 0 - 4 h Post-dose	Average heart rate over 4 h	0, 30min, 2h, 4h	No
Secondary	QTcB, Peak Effect Over 0 - 4 h Post-dose	Maximum QTc Bazett over 4 h	0, 30min, 2h, 4h	No
Secondary	QTcB, Average Effect Over 0 - 4 h Post-dose	Average QTc Bazett over 4 h	0, 30min, 2h, 4h	No
Secondary	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.	0, 15min, 30min, 1h, 2h, 4h	No
Secondary	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.	0, 15min, 30min, 1h, 2h, 4h	No
Secondary	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	0, 15min, 30min, 1h, 2h, 4h	No
Secondary	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	0, 15min, 30min, 1h, 2h, 4h	No
Secondary	Plasma AZD3199 Cmax	Maximum plasma concentration of AZD3199 measured	0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h	No
Secondary	Plasma AZD3199 AUC0-24	Area under the plasma concentration curve from time 0 to 24 h post-dose	0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h	No

External Links

•   Link
•   D0570C00007 CSR Synopsis