Clinical trial NCT02091986: A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
Official title: A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma, children, budesonide pMDI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 882
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: The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.

Detailed description: A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma

Eligibility criteria: Inclusion Criteria:

* Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
* Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
* Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.

Exclusion Criteria:

* Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
* Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1

Primary outcomes:
measure: Change From Baseline to Week 12 in 1h Post-dose FEV1
timeFrame: Week 0 (baseline), Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in 1h Post-dose PEF
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in 1h Post-dose FEF25-75
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in 1h Post-dose FVC
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in Pre-dose FEV1
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in Pre-dose PEF
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in Pre-dose FEF25-75
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in Pre-dose FVC
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Week 12 in 15 Min Post-dose FEV1
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to End of Study Average in Total Asthma Symptoms
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to End of Study Average in Total Daily Reliever Medication
timeFrame: Week 0 (baseline), Week 12
measure: Change From Baseline to Study Period Average in Overall PAQLQ Score
timeFrame: Week 0 (baseline), week 4, week 8, week 12
measure: Number of Patients With an Asthma Exacerbation During Study
timeFrame: Week 0 (baseline) up to Week 12
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Research Site
state: Alabama
city: Montgomery
country: United States
facility: Research Site
state: Alabama
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Ontario
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Fort Walton Beach
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Homestead
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Largo
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Williston
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Lenexa
country: United States
facility: Research Site
state: Kansas
city: Waldorf
country: United States
facility: Research Site
state: Maryland
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Verona
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Rockville Centre
country: United States
facility: Research Site
state: New York
city: Watertown
country: United States
facility: Research Site
state: New York
city: Charlotte
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: Toledo
country: United States
facility: Research Site
state: Ohio
city: Edmond
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Gresham
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: Upland
country: United States
facility: Research Site
state: Pennsylvania
city: North Charleston
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: West Columbia
country: United States
facility: Research Site
state: South Carolina
city: Allen
country: United States
facility: Research Site
state: Texas
city: Baytown
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: Houston
country: United States
facility: Research Site
state: Texas
city: Kerville
country: United States
facility: Research Site
state: Texas
city: Richmond
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: Murray
country: United States
facility: Research Site
state: Utah
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Washington
country: United States
facility: Research Site
state: Washington
city: Cuautitlan Izcalli
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Ciudad de Panama
country: Panama
facility: Research Site
city: David Chiriqui
country: Panama
facility: Research Site
city: Panama
country: Panama
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
Study officials:
affiliation: Colorado Allergy Asthma Centers, PC, US
name: David S Pearlman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Mölndal, Sweden
name: Carin Jorup, MD
role: STUDY_DIRECTOR
References:
citation: Pearlman DS, Eckerwall G, McLaren J, Lamarca R, Puu M, Gilbert I, Jorup C, Sandin K, Lanz MJ. Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years). Ann Allergy Asthma Immunol. 2017 Apr;118(4):489-499.e1. doi: 10.1016/j.anai.2017.01.020. Epub 2017 Mar 1.