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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02308098
• Date of registration: 02/12/2014
• Prospective Registration: No
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product BUFODIL
• Scientific 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
• Date of first enrolment: December 2014
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02308098
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Bulgaria, Hungary

Contacts

• Name: Hristo Metev, MD
• Affiliation: Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD

Key inclusion & 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 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

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

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

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

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

Drug: Placebo 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 1inh

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

Primary Outcome(s)

Average FEV1 [Time Frame: 12 h]

Secondary Outcome(s)

FEV1 at 12 h [Time Frame: 12 h]

Maximum FEV1 [Time Frame: 12 h]

Secondary ID(s)

3103013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors