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

Asthma Clinical Trial

— BUFODIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308098
• Other study ID #: 3103013
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2014
• Last updated: June 29, 2015
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2015
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß2-agonist, a xanthine-derivative, a ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bulgaria	Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD	Ruse

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average FEV1	FEV1 determined from serial spirometry and calculated on the basis of area under the curve	12 h	No
Secondary	Maximum FEV1	Maximum FEV1 over the 12-hour serial assessments	12 h	No
Secondary	FEV1 at 12 h	FEV1 at 12 hours post-dose	12 h	No