Status:
COMPLETED
To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02308098
Start Date
December 1 2014
End Date
June 1 2015
Last Update
June 30 2015
Active Locations (1)
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1
Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Rousse, Bulgaria