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Completed

NCT Number: NCT02091986

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

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Cuautitlán Izcalli, Mexico

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symbicort pMDI

Drug

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

Budesonide pMDI

Other

Budesonide pMDI 80µg, 2 acuations twice daily

Other names: Active comparator

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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

    • = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
    • = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
    • = 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).

  10. 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).

  11. 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).

  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.

  13. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: CHASE 3

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2014
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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