Study Comparing Bronchodilator Efficacy of Two Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler; a Randomised, Double-blind, Double-dummy, Multicentre, Single Dose, Crossover Study in Asthmatic Subjects
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Average FEV1
Study Overview
Brief Summary
The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Intervention: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh (Drug)
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Intervention: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh (Drug)
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Intervention: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh (Drug)
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh
Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Intervention: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh (Drug)
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh
Intervention: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh (Drug)
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh
Intervention: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh (Drug)
Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh
Intervention: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh (Drug)
Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh
Intervention: Symbicort Turbuhaler 320/9 ug/inhalation 1inh (Drug)
Outcomes
Primary Outcomes
Average FEV1
Time Frame: 12 h
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
Secondary Outcomes
- Maximum FEV1(12 h)
- FEV1 at 12 h(12 h)