Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02091986 |
Date of registration:
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18/03/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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 |
Scientific title:
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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 |
Date of first enrolment:
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April 2014 |
Target sample size:
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882 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02091986 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Panama
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Slovakia
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United States
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Contacts
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Name:
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David S Pearlman, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Colorado Allergy Asthma Centers, PC, US |
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Name:
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Carin Jorup, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca Mölndal, Sweden |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
11 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Symbicort pMDI
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Other: Budesonide pMDI
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Primary Outcome(s)
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Change From Baseline to Week 12 in 1h Post-dose FEV1
[Time Frame: Week 0 (baseline), Week 12]
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Secondary Outcome(s)
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Number of Patients With an Asthma Exacerbation During Study
[Time Frame: Week 0 (baseline) up to Week 12]
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Change From Baseline to End of Study Average in Total Asthma Symptoms
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in Pre-dose FEF25-75
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in Pre-dose FVC
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to End of Study Average in Total Daily Reliever Medication
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Study Period Average in Overall PAQLQ Score
[Time Frame: Week 0 (baseline), week 4, week 8, week 12]
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Change From Baseline to Week 12 in 15 Min Post-dose FEV1
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in Pre-dose FEV1
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in 1h Post-dose FVC
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in 1h Post-dose FEF25-75
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in 1h Post-dose PEF
[Time Frame: Week 0 (baseline), Week 12]
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Change From Baseline to Week 12 in Pre-dose PEF
[Time Frame: Week 0 (baseline), Week 12]
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Secondary ID(s)
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D589GC00003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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