Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

NCT ID: NCT00736489

Last Updated: 2014-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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crossover dose 1

AZD3199 120 microgram

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Dry powder for inhalation, single dose

crossover dose 2

AZD3199 480 microgram

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Dry powder for inhalation, single dose

crossover dose 3

AZD3199 1920 microgram

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Dry powder for inhalation, single dose

crossover dose 4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dry powder for inhalation, single dose

crossover dose 5

Formoterol 9 microgram

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

Dry powder for inhalation, single dose

crossover dose 6

Formoterol 36 microgram

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

Dry powder for inhalation, single dose

Interventions

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AZD3199

Dry powder for inhalation, single dose

Intervention Type DRUG

Formoterol

Dry powder for inhalation, single dose

Intervention Type DRUG

Placebo

Dry powder for inhalation, single dose

Intervention Type DRUG

Other Intervention Names

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Oxis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof Leif Bjermer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital in Lund, Sweden

Locations

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Research Site

Hvidovre, , Denmark

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Lund, , Sweden

Site Status

Countries

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Denmark Sweden

References

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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.

Reference Type DERIVED
PMID: 23907810 (View on PubMed)

Other Identifiers

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ToBe

Identifier Type: -

Identifier Source: secondary_id

D0570C00007

Identifier Type: -

Identifier Source: org_study_id

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