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Single-Dose Crossover Study to Investigate Pharmacodynamics of AZD3199

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00736489
First received: August 15, 2008
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
Airway Obstruction
 Drug: AZD3199
Drug: Formoterol
Drug: Placebo
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Forced Expiratory Volume in first second [ Time Frame: Before and up to 26 h after dosing. 17 assessments per dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug exposure and pharmacokinetics [ Time Frame: Before and up to 24 h after dosing. 10 assessments per dose. ] [ Designated as safety issue: No ]
  • Incidence and nature of adverse events, clinical laboratory assessments, and physical examination [ Time Frame: Before and up to 24 h after dosing. 2 assessments per dose. ] [ Designated as safety issue: No ]
  • Tremor, palpitations, heart rate, QTc, pulse and blood pressure [ Time Frame: Before and after dosing. 7 assessments per dose. ] [ Designated as safety issue: No ]
  • Potassium serum concentration [ Time Frame: Before and up to 24 h after dosing. 6 assessments per dose. ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: crossover dose 1
AZD3199 120 microgram
 Drug: AZD3199
Dry powder for inhalation, single dose
Experimental: crossover dose 2
AZD3199 480 microgram
 Drug: AZD3199
Dry powder for inhalation, single dose
Experimental: crossover dose 3
AZD3199 1920 microgram
 Drug: AZD3199
Dry powder for inhalation, single dose
Placebo Comparator: crossover dose 4
Placebo
 Drug: Placebo
Dry powder for inhalation, single dose
Active Comparator: crossover dose 5
Formoterol 9 microgram
 Drug: Formoterol
Dry powder for inhalation, single dose
Other Name: Oxis
Active Comparator: crossover dose 6
Formoterol 36 microgram
 Drug: Formoterol
Dry powder for inhalation, single dose
Other Name: Oxis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736489

Locations
Denmark
Research Site
Hvidovre, Denmark
Sweden
Research Site
Goteborg, Sweden
Research Site
Lulea, Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof Leif Bjermer, MD, PhD University Hospital in Lund, Sweden
  More Information

No publications provided

Responsible Party: Lars Grundemar, MD, Medical Science Director, Emerging Respiratory 3, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT00736489     History of Changes
Other Study ID Numbers: D0570C00007, ToBe
Study First Received: August 15, 2008
Last Updated: April 30, 2009
Health Authority: Sweden: Regional Ethical Review Board
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency

Keywords provided by AstraZeneca:
Asthma
airway obstruction
beta2-agonist
efficacy
inhalation

Additional relevant MeSH terms:
Airway Obstruction
Asthma
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013