Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

NCT00736489 | Completed Phase 2 Results

• 2 other identifiers: D0570C00007ToBe
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Asthma; Airway Obstruction

Keywords

Asthma; airway obstruction; beta2-agonist; efficacy; inhalation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

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

  Average S-potassium concentration

  0, 15min, 30min,1h, 2h, 4h

Secondary Outcomes (20)

• FEV1 Effect at 5 Min Post-dose

  5min

• FEV1 Average Effect Over 0 - 24 h Post-dose

  0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h

• FEV1 Average Effect Over 0 - 12 h Post-dose

  0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h

• FEV1 Average Effect Over 12 - 24 h Post-dose

  12h, 14h, 18h, 22h, 24h

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

  0, 30min, 2h, 4h

Study Arms (6)

crossover dose 1

EXPERIMENTAL

AZD3199 120 microgram

Drug: AZD3199

crossover dose 2

EXPERIMENTAL

AZD3199 480 microgram

Drug: AZD3199

crossover dose 3

EXPERIMENTAL

AZD3199 1920 microgram

Drug: AZD3199

crossover dose 4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

crossover dose 5

ACTIVE COMPARATOR

Formoterol 9 microgram

Drug: Formoterol

crossover dose 6

ACTIVE COMPARATOR

Formoterol 36 microgram

Drug: Formoterol

Interventions

AZD3199 DRUG

Dry powder for inhalation, single dose

crossover dose 1; crossover dose 2; crossover dose 3

Formoterol DRUG

Dry powder for inhalation, single dose

Also known as: Oxis

crossover dose 5; crossover dose 6

Placebo DRUG

Dry powder for inhalation, single dose

crossover dose 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Hvidovre, Denmark

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Lund, Sweden

Location

Related Publications (1)

• 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.

  PMID: 23907810 DERIVED

Related Links

• Related Info
• D0570C00007 CSR Synopsis

MeSH Terms

Conditions

Asthma; Airway Obstruction; Respiratory Aspiration

Interventions

AZD-3199; Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Carin Jorup, MSD
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Prof Leif Bjermer, MD, PhD

  University Hospital in Lund, Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 19, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-04

Locations

SE (3); DK (1)