A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
NCT ID: NCT01136655
Last Updated: 2013-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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BUD 160/FM 2.25
2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
80/2.25 μg Symbicort pMDI
inhalation
40 μg budesonide HFA pMDI
inhalation
BUD 160/FM 4.5
placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations)
80/2.25 μg Symbicort pMDI
inhalation
placebo HFA pMDI
inhalation
BUD 160/FM 9.0
placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations)
80/4.5 μg Symbicort pMDI
inhalation
placebo HFA pMDI
inhalation
BUD 160
placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
40 μg budesonide HFA pMDI
inhalation
placebo HFA pMDI
inhalation
BUD 160/Foradil 12.0
Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
Foradil Aerolizer 12 μg
inhalation
40 μg budesonide HFA pMDI
inhalation
Interventions
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80/2.25 μg Symbicort pMDI
inhalation
80/4.5 μg Symbicort pMDI
inhalation
Foradil Aerolizer 12 μg
inhalation
40 μg budesonide HFA pMDI
inhalation
placebo HFA pMDI
inhalation
Eligibility Criteria
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Inclusion Criteria
* Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
* Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist
Exclusion Criteria
* Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.
6 Years
11 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lars-Goran Carlsson, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Huntington, California, United States
Research Site
Long Beach, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Orange, California, United States
Research Site
Rolling Hills Estate, California, United States
Research Site
Sarasota, Florida, United States
Research Site
Omaha, Nebraska, United States
Research Site
Morrisville, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Eugene, Oregon, United States
Research Site
Lake Oswego, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Altoona, Pennsylvania, United States
Research Site
Upland, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
El Paso, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Waco, Texas, United States
Research Site
Springfield, Virginia, United States
Research Site
Dublin, , Bulgaria
Research Site
Dublin, , Czechia
Research Site
Budapest, , Hungary
Research Site
Dublin, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Sopron, , Hungary
Research Site
Dublin, , Poland
Research Site
Krugersdorp, Gauteng, South Africa
Research Site
Pietermariztburg, KwaZulu-Natal, South Africa
Research Site
Durban, Kz-natal, South Africa
Research Site
Cape Town, South Africa, South Africa
Research Site
Cape Town, W Cape, South Africa
Research Site
Claremont, W Cape, South Africa
Research Site
Dublin, , South Africa
Countries
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References
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Berger WE, Gillen M, Eckerwall G, Uryniak T, Trudo FJ, Lampl KL. Bronchodilator effect of single-dose formoterol administered by pressurized metered-dose inhaler in children with asthma aged 6 to <12 years receiving budesonide. Allergy Asthma Proc. 2014 Mar-Apr;35(2):134-40. doi: 10.2500/aap.2014.35.3746.
Other Identifiers
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D589GC00002
Identifier Type: -
Identifier Source: org_study_id