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A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo (CHASE 1)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
budesonide
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, children, budesonide pMDI

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

Placebo pMDI 2 inhalations bid

Outcomes

Primary Outcome Measures

Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

Secondary Outcome Measures

Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Change in Evening PEF From Baseline to the Treatment Period Average
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were 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.
Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were 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.
Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, "Did your asthma cause you to wake-up last night?" If yes, patients were asked, "Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?" Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.
Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"
Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"
Number of Withdrawals Due to Pre-defined Asthma Events
Patients were considered to have experienced a "pre-defined asthma event" if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.

Full Information

First Posted
June 1, 2010
Last Updated
July 30, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01136382
Brief Title
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
Acronym
CHASE 1
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, children, budesonide pMDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo pMDI 2 inhalations bid
Intervention Type
Drug
Intervention Name(s)
budesonide
Intervention Description
pMDI, inhalation, bid, 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
pMDI, inhalation, bid, 6 weeks
Primary Outcome Measure Information:
Title
Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
Description
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
Description
FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame
Baseline to 6 weeks
Title
Change in Evening PEF From Baseline to the Treatment Period Average
Description
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame
Baseline to 6 weeks
Title
Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
Description
FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame
Baseline to 6 weeks
Title
Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
Description
FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame
Baseline to 6 weeks
Title
Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Description
Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were 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.
Time Frame
Baseline to 6 weeks
Title
Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
Description
Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were 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.
Time Frame
Baseline to 6 weeks
Title
Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
Description
Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, "Did your asthma cause you to wake-up last night?" If yes, patients were asked, "Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?" Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.
Time Frame
Baseline to 6 weeks
Title
Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
Description
The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"
Time Frame
Baseline to 6 weeks
Title
Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
Description
The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, "How many albuterol/salbutamol inhalations since last diary entry?"
Time Frame
Baseline to 6 weeks
Title
Number of Withdrawals Due to Pre-defined Asthma Events
Description
Patients were considered to have experienced a "pre-defined asthma event" if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Göran Eckerwall, MD
Organizational Affiliation
AZ R&D Mölndal
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
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City
Fresno
State/Province
California
Country
United States
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Granada Hills
State/Province
California
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United States
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Huntington Beach
State/Province
California
Country
United States
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City
Mission Viejo
State/Province
California
Country
United States
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Orange
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California
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United States
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Palmdal
State/Province
California
Country
United States
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City
Rolling Hills Estate
State/Province
California
Country
United States
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San Diego
State/Province
California
Country
United States
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City
Stockton
State/Province
California
Country
United States
Facility Name
Research Site
City
Centennial
State/Province
Colorado
Country
United States
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City
Colorado Springs
State/Province
Colorado
Country
United States
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Denver
State/Province
Colorado
Country
United States
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Coral Gables
State/Province
Florida
Country
United States
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Orange City
State/Province
Florida
Country
United States
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Sarasota
State/Province
Florida
Country
United States
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Albany
State/Province
Georgia
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United States
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Gainesville
State/Province
Georgia
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United States
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Normal
State/Province
Illinois
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United States
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Overland Park
State/Province
Kansas
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United States
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Bethesda
State/Province
Maryland
Country
United States
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North Dartmouth
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Massachusetts
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United States
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Ypsilanti
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Michigan
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United States
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Plymouth
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Minnesota
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United States
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Columbia
State/Province
Missouri
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United States
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City
St Louis
State/Province
Missouri
Country
United States
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Boseman
State/Province
Montana
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United States
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City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
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City
Ocean
State/Province
New Jersey
Country
United States
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City
Skillman
State/Province
New Jersey
Country
United States
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City
Teaneck
State/Province
New Jersey
Country
United States
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City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
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City
High Point
State/Province
North Carolina
Country
United States
Facility Name
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City
Canton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
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City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
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City
Gresham
State/Province
Oregon
Country
United States
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City
Lake Oswego
State/Province
Oregon
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United States
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Medford
State/Province
Oregon
Country
United States
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City
Portland
State/Province
Oregon
Country
United States
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City
Altoona
State/Province
Pennsylvania
Country
United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
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Upland
State/Province
Pennsylvania
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United States
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Charleston
State/Province
South Carolina
Country
United States
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Dallas
State/Province
Texas
Country
United States
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City
El Paso
State/Province
Texas
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United States
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City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Georgetown
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Greenfield
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
West Allis
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Kiskunhalas
Country
Hungary
Facility Name
Research Site
City
Marcali
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Sopron
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Hungary
Facility Name
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City
Szeged
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Hungary
Facility Name
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City
Szigetvar
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Hungary
Facility Name
Research Site
City
Torokbalint
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Hungary
Facility Name
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City
Zalaegerszeg
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Hungary
Facility Name
Research Site
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Ogre
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Latvia
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Research Site
City
Rezekne
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Latvia
Facility Name
Research Site
City
Riga
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Latvia
Facility Name
Research Site
City
Bialystok
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Poland
Facility Name
Research Site
City
Czestochowa
Country
Poland
Facility Name
Research Site
City
Karpacz
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Pabianice
Country
Poland
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Lucenec
Country
Slovakia
Facility Name
Research Site
City
Krugersdorp
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Durban
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Research Site
City
Pietermariztburg
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Research Site
City
Claremont
State/Province
W Cape
Country
South Africa
Facility Name
Research Site
City
Panorama
State/Province
W Cape
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
26460293
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.
Results Reference
derived

Learn more about this trial

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

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