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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
1
Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)
Intervention: budesonide (Drug)
2
Placebo pMDI 2 inhalations bid
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
Time Frame: Baseline to 6 weeks
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 Outcomes
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Evening PEF From Baseline to the Treatment Period Average(Baseline to 6 weeks)
- Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average(Baseline to 6 weeks)
- Number of Withdrawals Due to Pre-defined Asthma Events(Baseline to 6 weeks)