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Clinical Trials/NCT01136382
NCT01136382CompletedPhase 2

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

AstraZeneca1 site in 1 country304 target enrollmentStarted: July 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Experimental

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

Intervention: budesonide (Drug)

2

Placebo Comparator

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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