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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

NCT ID: NCT02091986

Last Updated: 2017-04-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Symbicort pMDI 80/2.25 µg

Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily

Group Type ACTIVE_COMPARATOR

Symbicort pMDI

Intervention Type DRUG

Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily

Symbicort pMDI 80/4.5µg

Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

Group Type ACTIVE_COMPARATOR

Symbicort pMDI

Intervention Type DRUG

Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

Budesonide pMDI

Budesonide pMDI 80µg, 2 acuations twice daily

Group Type ACTIVE_COMPARATOR

Budesonide pMDI

Intervention Type OTHER

Budesonide pMDI 80µg, 2 acuations twice daily

Interventions

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Symbicort pMDI

Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily

Intervention Type DRUG

Symbicort pMDI

Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

Intervention Type DRUG

Budesonide pMDI

Budesonide pMDI 80µg, 2 acuations twice daily

Intervention Type OTHER

Other Intervention Names

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Active comparator

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 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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David S Pearlman, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Allergy Asthma Centers, PC, US

Carin Jorup, MD

Role: STUDY_DIRECTOR

AstraZeneca Mölndal, Sweden

Locations

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Research Site

Hoover, Alabama, United States

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Montgomery, Alabama, United States

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Gilbert, Arizona, United States

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Little Rock, Arkansas, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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Newport Beach, California, United States

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Ontario, California, United States

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Stockton, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Aventura, Florida, United States

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Coral Gables, Florida, United States

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Fort Walton Beach, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Williston, Florida, United States

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Winter Park, Florida, United States

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Savannah, Georgia, United States

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Stockbridge, Georgia, United States

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Lenexa, Kansas, United States

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Waldorf, Maryland, United States

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Plymouth, Minnesota, United States

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Bellevue, Nebraska, United States

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Verona, New Jersey, United States

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Albuquerque, New Mexico, United States

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Rockville Centre, New York, United States

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Watertown, New York, United States

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Charlotte, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Edmond, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Gresham, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Upland, Pennsylvania, United States

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North Charleston, South Carolina, United States

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Spartanburg, South Carolina, United States

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West Columbia, South Carolina, United States

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Allen, Texas, United States

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Baytown, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Kerville, Texas, United States

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Richmond, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Murray, Utah, United States

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Fairfax, Virginia, United States

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Tacoma, Washington, United States

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Washington, Washington, United States

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Cuautitlán Izcalli, , Mexico

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México, , Mexico

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Monterrey, , Mexico

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David Chiriqui, , Panama

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Panama City, , Panama

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Lučenec, , Slovakia

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Poprad, , Slovakia

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Prešov, , Slovakia

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Countries

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United States Mexico Panama Slovakia

References

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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.

Reference Type DERIVED
PMID: 28256307 (View on PubMed)

Other Identifiers

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D589GC00003

Identifier Type: -

Identifier Source: org_study_id

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