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A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

NCT ID: NCT01136382

Last Updated: 2014-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Detailed Description

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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

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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1

Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)

Group Type EXPERIMENTAL

budesonide

Intervention Type DRUG

pMDI, inhalation, bid, 6 weeks

2

Placebo pMDI 2 inhalations bid

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

pMDI, inhalation, bid, 6 weeks

Interventions

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budesonide

pMDI, inhalation, bid, 6 weeks

Intervention Type DRUG

placebo

pMDI, inhalation, bid, 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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
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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Göran Eckerwall, MD

Role: STUDY_DIRECTOR

AZ R&D Mölndal

Locations

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Research Site

Scottsdale, Arizona, United States

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Fresno, California, United States

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Granada Hills, California, United States

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Huntington Beach, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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Palmdal, California, United States

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Rolling Hills Estate, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Coral Gables, Florida, United States

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Orange City, Florida, United States

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Sarasota, Florida, United States

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Albany, Georgia, United States

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Gainesville, Georgia, United States

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Normal, Illinois, United States

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Overland Park, Kansas, United States

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Bethesda, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Ypsilanti, Michigan, United States

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Plymouth, Minnesota, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Bozeman, Montana, United States

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Bellevue, Nebraska, United States

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Omaha, Nebraska, United States

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Ocean City, New Jersey, United States

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Skillman, New Jersey, United States

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Teaneck, New Jersey, United States

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Rockville Centre, New York, United States

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High Point, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Sylvania, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Gresham, Oregon, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Charleston, South Carolina, United States

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Dallas, 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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Georgetown, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Richmond, Virginia, United States

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Greenfield, Wisconsin, United States

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West Allis, Wisconsin, United States

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Kiskunhalas, , Hungary

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Marcali, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Sopron, , Hungary

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Szeged, , Hungary

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Szigetvár, , Hungary

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Törökbálint, , Hungary

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Zalaegerszeg, , Hungary

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Ogre, , Latvia

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Rēzekne, , Latvia

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Riga, , Latvia

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Bialystok, , Poland

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Częstochowa, , Poland

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Karpacz, , Poland

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Lodz, , Poland

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Pabianice, , Poland

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Bratislava, , Slovakia

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Lučenec, , Slovakia

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Krugersdorp, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Pietermariztburg, KwaZulu-Natal, South Africa

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Claremont, W Cape, South Africa

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Panorama, W Cape, South Africa

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Countries

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United States Bulgaria Hungary Latvia Poland Slovakia South Africa

References

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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.

Reference Type DERIVED
PMID: 26460293 (View on PubMed)

Other Identifiers

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D589GC00001

Identifier Type: -

Identifier Source: org_study_id

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