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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 (CHASE 3)

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ClinicalTrials.gov Identifier: NCT02091986
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 18, 2014
First Posted Date  ICMJE March 19, 2014
Results First Submitted Date  ICMJE October 11, 2016
Results First Posted Date  ICMJE April 10, 2017
Last Update Posted Date April 10, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
Change from baseline in one-hour post-dose forced expiratory volume in the first second (FEV1) [ Time Frame: Baseline to Week 12 ]
Change from baseline to Week 12 in one-hour post-dose FEV1
Change History Complete list of historical versions of study NCT02091986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
  • Change from baseline in one-hour post-dose clinic FVC (L) [ Time Frame: Baseline taken at Week 0 then at Weeks 2, 4, 8 and 12 ]
    Change from baseline to one-hour post-dose FVC at Weeks 2, 4, 8 and 12
  • Change from baseline in one-hour post-dose clinic FEF25-75 (L/s) measured in the clinic [ Time Frame: Baseline taken at Week 0 then at Weeks 2,4,8 and 12 ]
    Change from baseline to one-hour post-dose FEF25-75 at Weeks 2, 4, 8 and 12
  • Change from baseline in one-hour post-dose peak expiratory flow (PEF) (L/min) measured in the clinic (clinic PEF) [ Time Frame: Baseline taken at Week 0 then at Weeks 2,4,8 and 12 ]
    Change from baseline to one-hour post-dose PEF at Weeks 2, 4, 8 and 12
  • Change from baseline in one-hour post-dose FEV1 [ Time Frame: Weeks 2, 4 and 8 ]
    Change from baseline in one-hour post dose FEV1 at Weeks 2, 4 and 8
  • Change from baseline in pre-dose clinic FEV1 in liter (L). [ Time Frame: Baseline to Week 2,4,8 and12 ]
    Change from baseline to pre-dose FEV1 at Weeks 2,4,8 and 12
  • Change from baseline in pre-dose clinic FVC (L) [ Time Frame: Baseline to Week 2,4,8 and12 ]
    Change from baseline to pre-dose FVC (L) at Weeks 2,4,8 and 12
  • Change from baseline in pre-dose clinic FEF25-75 (L/s) [ Time Frame: Baseline to Week 2,4,8 and12 ]
    Change from baseline to pre-dose FEF25-75 at Weeks 2,4,8 and 12
  • Change from baseline in pre-dose clinic Peak expiratory flow (PEF) (L/min) [ Time Frame: Baseline to Week 2, 4, 8 and12 ]
    Change from baseline to pre-dose PEF at Weeks 2, 4, 8 and 12
  • Change from baseline in fifteen-minute post-dose clinic FEV1 (L) [ Time Frame: Baseline taken at Week 0 then at Week 12. ]
    Change from baseline to one-hour post-dose FEV1 at Week 12
  • Change from baseline in fifteen-minute post-dose clinic clinic FVC (L) [ Time Frame: Baseline taken at Week 0 then at Week 12. ]
    Change from baseline to one-hour post-dose FVC at Week 12
  • Change from baseline in fifteen-minute post-dose clinic FEF25-75 (L/s) [ Time Frame: Baseline taken at Week 0 then at Week 12. ]
    Change from baseline to one-hour post-dose FEF25-75 at Week 12
  • Change from baseline in fifteen-minute post-dose clinic PEF (L/min) [ Time Frame: Baseline taken at Week 0 then at Week 12. ]
    Change from baseline to one-hour post-dose clinic PEF (L/min) at Week 12
  • Time to occurrence of first asthma exacerbation [ Time Frame: Randomized 12-week treatment period ]
    Time in days from randomization until first exacerbation during the 12-week treatment period.
  • Change from baseline in nighttime awakenings due to asthma symptoms requiring reliever use recorded in the eDiary during the single blind run in and the double blind treatment periods [ Time Frame: Baseline taken as percentage of nighttime awakenings during the last 7 days of run-in. Week 12 taken as percentage of nighttime awakenings during Treatment Week 12. ]
    Change in percentage of nighttime awakenings from baseline Treatment Week 12
  • Change from baseline in paediatric Asthma Quality of Life Questionnaire with Standardised Activities (PAQLQ[S]) scores (overall and each domain) [ Time Frame: Baseline taken at Week 0 then at Weeks 4, 8 and 12 ]
    Change from baseline PAQLQ(S) to mean of Weeks 4, 8 and 12
  • Change from baseline in morning and evening FEV1 (L) recorded in the electronic diary (eDiary) [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from baseline mean in diary FEV1 to mean at Week 12
  • Change from baseline in nighttime reliever medication use recorded in the eDiary [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from mean baseline to Treatment Week 12 mean in nighttime reliever medication use.
  • Change from baseline in daytime reliever medication use recorded in the eDiary [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from mean baseline to Treatment Week 12 mean in daytime reliever medication use.
  • Change from baseline in total daily reliever medication use recorded in the eDiary [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from mean baseline to Treatment Week 12 mean in total reliever medication use.
  • Change from baseline in nighttime asthma symptom scores recorded in the eDiary [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from mean baseline score to mean score during Week 12
  • Change from baseline in daytime asthma symptom scores recorded in the eDiary [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from mean baseline score to mean score during Week 12
  • Change from baseline in total daily asthma symptom scores recorded in the eDiary [ Time Frame: Baseline taken as the mean of the last 7 days of the run-in period. Week 12 taken as the mean during Week 12 of the treatment period. ]
    Change from mean baseline score to mean score during Week 12
  • Time to discontinuation of investigational product (IP). [ Time Frame: Randomized 12-week treatment period ]
    Time in days from randomization until discontinuation of investigational product during the 12-week treatment period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
  • Other: Budesonide pMDI
    Budesonide pMDI 80µg, 2 acuations twice daily
    Other Name: Active comparator
Study Arms  ICMJE
  • Active Comparator: Symbicort pMDI 80/2.25 µg
    Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
    Intervention: Drug: Symbicort pMDI
  • Active Comparator: Symbicort pMDI 80/4.5µg
    Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
    Intervention: Drug: Symbicort pMDI
  • Active Comparator: Budesonide pMDI
    Budesonide pMDI 80µg, 2 acuations twice daily
    Intervention: Other: Budesonide pMDI
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2016)
882
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2014)
1116
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama,   Mexico,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02091986
Other Study ID Numbers  ICMJE D589GC00003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S Pearlman, MD Colorado Allergy Asthma Centers, PC, US
Study Director: Carin Jorup, MD AstraZeneca Mölndal, Sweden
PRS Account AstraZeneca
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP