A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Study Overview
Brief Summary
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female 12 years and above
- •Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
- •Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
- •Patients with reversible airway obstruction
- •Documented daily use of inhaled corticosteroids for ≥ 3 months
Exclusion Criteria
- •History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
- •Hospitalized during previous 6 months for asthma
- •Required emergency treatment more than once during previous 6 months for an asthma-related condition
- •Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
- •Respiratory infection affecting the asthma within 30 days
Arms & Interventions
1 Symbicort/inhaler
Symbicort BA MDI 2x160/4.5 μg twice daily
Intervention: Symbicort (Drug)
Symbicort/inhaler
Symbicort AC pDMI 2x160/4.5 μg twice daily
Intervention: Symbicort (Drug)
Budesonide/inhaler
Budesonide AC pMDI 2x160 μg twice daily
Intervention: Budesonide (Drug)
Outcomes
Primary Outcomes
Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Time Frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
Time Frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Secondary Outcomes
- Peak Expiratory Flow(Recorded morning upon rising and evening before sleep for 14 weeks)
- Asthma Symptoms Score (Total)(Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks)
- Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)(Recorded 6:00 - 11:00 AM for 14 weeks)
- Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)(Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks)