A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
Overview
- Phase
- Phase 3
- Intervention
- budesonide/formoterol 'as needed' + budesonide placebo bid
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 3850
- Locations
- 1
- Primary Endpoint
- 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.
Detailed Description
A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 μg 'as needed' compared with terbutaline Turbuhaler® 0.4 mg 'as needed' and with Pulmicort® (budesonide) Turbuhaler® 200 μg twice daily plus terbutaline Turbuhaler® 0.4 mg 'as needed'
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Symbicort "as needed"+placebo Pulmicort bid
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
Intervention: budesonide/formoterol 'as needed' + budesonide placebo bid
terbutaline "as needed"+placebo Pulmicort bid
terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid
Intervention: terbutaline 'as needed' + placebo budesonide bid
Pulmicort bid + terbutaline "as needed"
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Intervention: budesonide bid + terbutaline 'as needed'
Outcomes
Primary Outcomes
'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
Time Frame: Weekly, up to 52 weeks
A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score \>1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
Secondary Outcomes
- Average Change From Baseline in Evening PEF(up to 52 weeks)
- Number of Participants Experiencing at Least One Severe Asthma Exacerbation(Day 1 up to 52 weeks)
- Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation(Day 1 up to 52 weeks)
- Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)(Study weeks 0,4,16,28,40,52)
- Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma(up to 52 weeks)
- Average Change From Baseline in Morning Peak Expiratory Flow (PEF)(up to 52 weeks)
- Change From Baseline in Percentage of 'As Needed' Free Days(up to 52 weeks)
- Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.(up to 52 weeks)
- Average Change From Baseline in Asthma Symptom Score(up to 52 weeks)
- Change From Baseline in Percentage of Symptom-free Days(up to 52 weeks)
- Change From Baseline in Percentage of Asthma Control Days(up to 52 weeks)
- Number of Patients With Study Specific Asthma Related Discontinuation(up to 52 weeks)
- Poorly Controlled Asthma Weeks(Weekly for up to 52 weeks)
- Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma(Day 1 up to 52 weeks)
- Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)(Study weeks 0,4,16,28,40,52)
- Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))(Study weeks 0,16,28,40,52)
- Percentage of Controller Use Days(up to 52 weeks)
- Annual Severe Asthma Exacerbation Rate(up to 52 weeks)
- Annual Moderate or Severe Asthma Exacerbation Rate(up to 52 weeks)