The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
NCT ID: NCT01225549
Last Updated: 2015-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2010-11-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
AZD5423 75ug
AZD5423
Suspension for nebulisation once daily 7 days
Placebo
Solution for nebulisation once daily 7 days
2
AZD5423 300ug
AZD5423
Suspension for nebulisation once daily 7 days
Placebo
Solution for nebulisation once daily 7 days
3
Budesonide 200 microgram
Budesonide 200 microgram
Dry powder for inhalation twice daily 7 days
Placebo
Solution for nebulisation once daily 7 days
4
Placebo
Placebo
Solution for nebulisation once daily 7 days
Placebo
Solution for nebulisation once daily 7 days
Interventions
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AZD5423
Suspension for nebulisation once daily 7 days
Budesonide 200 microgram
Dry powder for inhalation twice daily 7 days
Placebo
Solution for nebulisation once daily 7 days
Placebo
Solution for nebulisation once daily 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
* Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
* Positive skin prick test to common aeroallergens
Exclusion Criteria
* Any clinically relevant abnormal finding at screening examinations
* Smoker or ex-smoker who has stopped smoking \< 12 months prior to study start
* Worsening of asthma or respiratory infection within 6 weeks from visit 1
* Allergen-specific immunotherapy within 6 months prior to visit 1
18 Years
60 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Christer Hultquist
Role: STUDY_DIRECTOR
AstraZeneca R&D, Mölndal, Sweden
Locations
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Research Site
Calgary, Alberta, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Countries
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References
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Gauvreau GM, Boulet LP, Leigh R, Cockcroft DW, Killian KJ, Davis BE, Deschesnes F, Watson RM, Swystun V, Mardh CK, Wessman P, Jorup C, Aurivillius M, O'Byrne PM. A nonsteroidal glucocorticoid receptor agonist inhibits allergen-induced late asthmatic responses. Am J Respir Crit Care Med. 2015 Jan 15;191(2):161-7. doi: 10.1164/rccm.201404-0623OC.
Related Links
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Other Identifiers
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D2340C00005
Identifier Type: -
Identifier Source: org_study_id
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