To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

Study Overview
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Brief Summary
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The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
* Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
* Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
* Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh
* Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
* Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
* Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
* Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Written informed consent Asthma diagnosis for at least 6 months Prebronchodilator FEV1 45-90% of the predicted value Demonstration of reversible airway obstruction Stable asthma on the same regular treatment for at least 4 weeks before the study Non-smoker for at least 6 months before the study Main exclusion criteria Respiratory infection within 4 weeks before the study Smoking history of more than 10 pack-years Other severe chronic respiratory disease than asthma Concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study Corrected QT interval > 450 ms in males or > 470 ms in females Abnormal serum potassium value or other clinically significant laboratory finding Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg Treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study Use of drugs that prolong QT-interval Women who are pregnant, breast-feeding or without reliable contraception Participation in another clinical drug study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh<br>Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh | Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh<br> <br> Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh<br> <br> |
| Experimental: Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh<br>Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh | Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh<br> <br> Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh<br> <br> |
| Experimental: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh<br>Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh | Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh<br> <br> Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh<br> <br> |
| Experimental: Symbicort Turbuhaler 320/9 ug/inhalation 1 inh<br>Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh | Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh<br> <br> Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average FEV1 | FEV1 determined from serial spirometry and calculated on the basis of area under the curve | 12 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum FEV1 | Maximum FEV1 over the 12-hour serial assessments | 12 h | 
| FEV1 at 12 h | FEV1 at 12 hours post-dose | 12 h |