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

Orion Pharma

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh; Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh; Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh; Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh; Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh; Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh; Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh; Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh

Study type: Interventional

Funder types: Industry

Identifiers

NCT02308098

3103013

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 4 patient groups

Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh

Experimental group

Description:

Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

Treatment:

Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh

Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh

Experimental group

Description:

Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

Treatment:

Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh

Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

Experimental group

Description:

Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh

Treatment:

Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh

Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

Experimental group

Description:

Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh

Treatment:

Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh

Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh