To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product
NCT ID: NCT02308098
Last Updated: 2015-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2014-12-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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
Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
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
Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
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
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
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
Symbicort Turbuhaler 320/9 ug/inhalation 1inh
Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
Interventions
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Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Symbicort Turbuhaler 320/9 ug/inhalation 1inh
Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh
Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh
Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Hristo Metev, MD
Role: PRINCIPAL_INVESTIGATOR
Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Locations
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Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Rousse, , Bulgaria
Countries
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References
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Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25.
Other Identifiers
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3103013
Identifier Type: -
Identifier Source: org_study_id