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 (CHASE 3)

February 24, 2017 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

882

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Cuautitlan Izcalli, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
  • Panama
      • Ciudad de Panama, Panama
        • Research Site
      • David Chiriqui, Panama
        • Research Site
      • Panama, Panama
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Poprad, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
  • United States
    • Alabama
      • Hoover, Alabama, United States
        • Research Site
      • Montgomery, Alabama, United States
        • Research Site
    • Arizona
      • Gilbert, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Huntington Beach, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Mission Viejo, California, United States
        • Research Site
      • Newport Beach, California, United States
        • Research Site
      • Ontario, California, United States
        • Research Site
      • Stockton, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
      • Denver, Colorado, United States
        • Research Site
    • Florida
      • Aventura, Florida, United States
        • Research Site
      • Coral Gables, Florida, United States
        • Research Site
      • Fort Walton Beach, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Homestead, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Largo, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Williston, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Savannah, Georgia, United States
        • Research Site
      • Stockbridge, Georgia, United States
        • Research Site
    • Kansas
      • Lenexa, Kansas, United States
        • Research Site
    • Maryland
      • Waldorf, Maryland, United States
        • Research Site
    • Minnesota
      • Plymouth, Minnesota, United States
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States
        • Research Site
    • New Jersey
      • Verona, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Rockville Centre, New York, United States
        • Research Site
      • Watertown, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
    • Ohio
      • Canton, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States
        • Research Site
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Gresham, Oregon, United States
        • Research Site
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Upland, Pennsylvania, United States
        • Research Site
    • South Carolina
      • North Charleston, South Carolina, United States
        • Research Site
      • Spartanburg, South Carolina, United States
        • Research Site
      • West Columbia, South Carolina, United States
        • Research Site
    • Texas
      • Allen, Texas, United States
        • Research Site
      • Baytown, Texas, United States
        • Research Site
      • El Paso, Texas, United States
        • Research Site
      • Fort Worth, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Kerville, Texas, United States
        • Research Site
      • Richmond, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Waco, Texas, United States
        • Research Site
    • Utah
      • Murray, Utah, United States
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States
        • Research Site
    • Washington
      • Tacoma, Washington, United States
        • Research Site
      • Washington, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Symbicort pMDI 80/2.25 µg
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Drug: Symbicort pMDI
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Drug: Symbicort pMDI
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Active Comparator: Symbicort pMDI 80/4.5µg
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Drug: Symbicort pMDI
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Drug: Symbicort pMDI
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Active Comparator: Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
Other: Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
Other Names:
  • Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in 1h Post-dose FEV1
Time Frame: Week 0 (baseline), Week 12
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in 1h Post-dose PEF
Time Frame: Week 0 (baseline), Week 12
1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FEF25-75
Time Frame: Week 0 (baseline), Week 12
1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FVC
Time Frame: Week 0 (baseline), Week 12
1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEV1
Time Frame: Week 0 (baseline), Week 12
Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose PEF
Time Frame: Week 0 (baseline), Week 12
Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEF25-75
Time Frame: Week 0 (baseline), Week 12
Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FVC
Time Frame: Week 0 (baseline), Week 12
Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 15 Min Post-dose FEV1
Time Frame: Week 0 (baseline), Week 12
15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Asthma Symptoms
Time Frame: Week 0 (baseline), Week 12

End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma

  1. = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
  2. = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
  3. = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep

Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6).
Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
Time Frame: Week 0 (baseline), Week 12
End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Daily Reliever Medication
Time Frame: Week 0 (baseline), Week 12
End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Week 0 (baseline), Week 12
Change From Baseline to Study Period Average in Overall PAQLQ Score
Time Frame: Week 0 (baseline), week 4, week 8, week 12

Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated.
Week 0 (baseline), week 4, week 8, week 12
Number of Patients With an Asthma Exacerbation During Study
Time Frame: Week 0 (baseline) up to Week 12
Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.
Week 0 (baseline) up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: David S Pearlman, MD, Colorado Allergy Asthma Centers, PC, US
  • Study Director: Carin Jorup, MD, AstraZeneca Mölndal, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589GC00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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