Clinical trial NCT01136382: A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
Official title: Phase 2, Double-blind, Randomized, Parallel-group, Placebo-controlled, Multicenter Study, Comparing Budesonide pMDI 160 ug Bid With Placebo: a 6-week Efficacy and Safety Study in Children Aged 6 to <12 Years With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma, children, budesonide pMDI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 304
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

Detailed description: Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to \<12 years with asthma

Eligibility criteria: Inclusion Criteria:

* Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2.
* Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal
* Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.

Exclusion Criteria:

* Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2
* Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2

Primary outcomes:
measure: Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Evening PEF From Baseline to the Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
timeFrame: Baseline to 6 weeks
measure: Number of Withdrawals Due to Pre-defined Asthma Events
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Fresno
country: United States
facility: Research Site
state: California
city: Granada Hills
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Palmdal
country: United States
facility: Research Site
state: California
city: Rolling Hills Estate
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Centennial
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Orange City
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Albany
country: United States
facility: Research Site
state: Georgia
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Ypsilanti
country: United States
facility: Research Site
state: Michigan
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: Boseman
country: United States
facility: Research Site
state: Montana
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Ocean
country: United States
facility: Research Site
state: New Jersey
city: Skillman
country: United States
facility: Research Site
state: New Jersey
city: Teaneck
country: United States
facility: Research Site
state: New Jersey
city: Rockville Centre
country: United States
facility: Research Site
state: New York
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Sylvania
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Gresham
country: United States
facility: Research Site
state: Oregon
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Georgetown
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Greenfield
country: United States
facility: Research Site
state: Wisconsin
city: West Allis
country: United States
facility: Research Site
state: Wisconsin
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kiskunhalas
country: Hungary
facility: Research Site
city: Marcali
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szigetvar
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Ogre
country: Latvia
facility: Research Site
city: Rezekne
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Czestochowa
country: Poland
facility: Research Site
city: Karpacz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Pabianice
country: Poland
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Krugersdorp
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site
state: Kwa Zulu Natal
city: Pietermariztburg
country: South Africa
facility: Research Site
state: Kwa Zulu Natal
city: Claremont
country: South Africa
facility: Research Site
state: W Cape
city: Panorama
country: South Africa
facility: Research Site
state: W Cape
Study officials:
affiliation: AZ R&D Mölndal
name: Göran Eckerwall, MD
role: STUDY_DIRECTOR
References:
citation: Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015 Dec;115(6):516-22. doi: 10.1016/j.anai.2015.09.007. Epub 2015 Oct 13.